A Study for Patients With Type 2 Diabetes Mellitus
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00804986
Collaborator
(none)
247
60
6
13
4.1
0.3
Study Details
Study Description
Brief Summary
A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
247 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 12-Week,Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients With Type 2 Diabetes Mellitus
Study Start Date
:
Dec 1, 2008
Actual Primary Completion Date
:
Jan 1, 2010
Actual Study Completion Date
:
Jan 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.5 mg LY2428757 Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
Drug: LY2428757
Once weekly for 12 weeks as a subcutaneous injection.
|
| Experimental: 2.0 mg LY2428757 Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
Drug: LY2428757
Once weekly for 12 weeks as a subcutaneous injection.
|
| Experimental: 6.2 mg LY2428757 Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
Drug: LY2428757
Once weekly for 12 weeks as a subcutaneous injection.
|
| Experimental: 12.0 mg LY2428757 Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
Drug: LY2428757
Once weekly for 12 weeks as a subcutaneous injection.
|
| Experimental: 17.6 mg LY2428757 Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
Drug: LY2428757
Once weekly for 12 weeks as a subcutaneous injection.
|
| Placebo Comparator: Placebo Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
Drug: Placebo
1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.
|
Outcome Measures
Primary Outcome Measures
- Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint [baseline, 12 weeks]
LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.
Secondary Outcome Measures
- Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint [baseline, 12 weeks]
The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
- Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study [baseline through 16 weeks]
Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.
- Total Average Concentration (Cavg) of LY2428757 [4 weeks, 6 weeks, 8 weeks, 10 weeks]
Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).
- Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint [baseline, 12 weeks]
Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
- Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint [baseline, 12 weeks]
An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
- Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint [baseline, 12 weeks]
An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
- Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint [baseline, 12 weeks]
An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
- Change in Fasting Lipids From Baseline to Week 12 Endpoint [baseline, 12 weeks]
Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.
- Change in Fasting Weight From Baseline to Week 12 Endpoint [baseline, 12 weeks]
LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
- Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint [baseline, 12 weeks]
Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
- Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint [baseline, 12 weeks]
DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
- Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint [baseline, 12 weeks]
Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
- Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint [Baseline, 12 Weeks]
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
-
Treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
-
Have a glycosylated fraction of hemoglobin A (HbA1c) value of 7.0% - 10.0% at screening
-
Women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
-
Have a body mass index (BMI) between 25 and 40 kilograms per square meters kg/m^2) at screening
-
Stable weight during the 3 months prior to screening.
Exclusion Criteria:
-
Use any antidiabetic agent other than metformin during the 2 months prior to screening.
-
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
-
Are currently taking prescription or over-the counter medications to promote weight loss.
-
Have been previously diagnosed with pancreatitis
-
Women who are breastfeeding.
-
Have a history of myocardial infarction, unstable angina, coronary artery bypass graft (CABG), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
-
Have poorly controlled hypertension
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bermuda Dunes | California | United States | 92203 |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chula Vista | California | United States | 91911 |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Huntington Beach | California | United States | 92648 |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Long Beach | California | United States | 90806 |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pomona | California | United States | 91767 |
| 6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sacramento | California | United States | 95825 |
| 7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Melbourne | Florida | United States | 32901 |
| 8 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chicago | Illinois | United States | 60607 |
| 9 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baltimore | Maryland | United States | 21204 |
| 10 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Waltham | Massachusetts | United States | 02453 |
| 11 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St Louis | Missouri | United States | 63141 |
| 12 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Las Vegas | Nevada | United States | 89101 |
| 13 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mentor | Ohio | United States | 44060 |
| 14 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Spokane | Washington | United States | 99220 |
| 15 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vancouver | Washington | United States | 98664 |
| 16 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vienna | Austria | 1090 | |
| 17 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vorarlberg | Austria | 6800 | |
| 18 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Berlin | Germany | 12627 | |
| 19 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamburg | Germany | 20253 | |
| 20 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Koln | Germany | 50931 | |
| 21 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lubeck | Germany | 23562 | |
| 22 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Magdeburg | Germany | 39104 | |
| 23 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mainz | Germany | D-55116 | |
| 24 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bangalore | India | 580043 | |
| 25 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chennai | India | 60004 | |
| 26 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cooperage | India | 400021 | |
| 27 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shivajinagar | India | 411005 | |
| 28 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Garza Garcia | Mexico | 66260 | |
| 29 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guadalajara | Mexico | 44340 | |
| 30 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | Mexico | 10700 | |
| 31 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Monterrey | Mexico | 64461 | |
| 32 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rio Piedras | Puerto Rico | 00921 | |
| 33 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brasov | Romania | 500365 | |
| 34 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucharest | Romania | 010507 | |
| 35 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cluj-Napoca | Romania | 400006 | |
| 36 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ploiesti | Romania | 100163 | |
| 37 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Satu Mare | Romania | 440055 | |
| 38 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sf Gheorghe | Romania | ||
| 39 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Targu Mures | Romania | 540142 | |
| 40 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bellville | South Africa | 7531 | |
| 41 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Benoni | South Africa | 1500 | |
| 42 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kempton Park | South Africa | 1619 | |
| 43 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Somerset West | South Africa | 7129 | |
| 44 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Granada | Spain | 18012 | |
| 45 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lleida | Spain | 25198 | |
| 46 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | Spain | 28046 | |
| 47 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santiago De Compostela | Spain | 15706 | |
| 48 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | Spain | 46017 | |
| 49 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dnepropetrovsk | Ukraine | 49027 | |
| 50 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dnipropetrovsk | Ukraine | 49023 | |
| 51 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Donetsk | Ukraine | 83037 | |
| 52 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kharkiv | Ukraine | 61048 | |
| 53 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kirovograd | Ukraine | 25001 | |
| 54 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyiv | Ukraine | 02175 | |
| 55 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Odessa | Ukraine | 65114 | |
| 56 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vinnytsia | Ukraine | 21010 | |
| 57 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bath | Banes | United Kingdom | BA1 3NG |
| 58 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barnsley | United Kingdom | S75 2EP | |
| 59 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Birmingham | United Kingdom | BS 5SS | |
| 60 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Liverpool | United Kingdom | L9 7AL |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00804986
Other Study ID Numbers:
- 12134
- I1I-MC-GECD
- CTRI/2009/091/000091
First Posted:
Dec 9, 2008
Last Update Posted:
Jul 14, 2011
Last Verified:
Jul 1, 2011
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Period Title: Overall Study | ||||||
| STARTED | 36 | 43 | 42 | 42 | 43 | 41 |
| COMPLETED | 35 | 35 | 40 | 34 | 34 | 31 |
| NOT COMPLETED | 1 | 8 | 2 | 8 | 9 | 10 |
Baseline Characteristics
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Total of all reporting groups |
| Overall Participants | 36 | 43 | 42 | 42 | 43 | 41 | 247 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
54.5
(8.06)
|
54.6
(8.33)
|
56.4
(8.07)
|
55.2
(9.78)
|
54.0
(9.45)
|
56.3
(9.88)
|
55.2
(8.93)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
15
41.7%
|
20
46.5%
|
24
57.1%
|
18
42.9%
|
22
51.2%
|
24
58.5%
|
123
49.8%
|
| Male |
21
58.3%
|
23
53.5%
|
18
42.9%
|
24
57.1%
|
21
48.8%
|
17
41.5%
|
124
50.2%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||||
| American Indian or Alaska Native |
2
5.6%
|
4
9.3%
|
1
2.4%
|
4
9.5%
|
1
2.3%
|
3
7.3%
|
15
6.1%
|
| Asian |
1
2.8%
|
1
2.3%
|
3
7.1%
|
1
2.4%
|
0
0%
|
1
2.4%
|
7
2.8%
|
| Black or African American |
9
25%
|
6
14%
|
8
19%
|
6
14.3%
|
10
23.3%
|
8
19.5%
|
47
19%
|
| Native Hawaiian or Pacific Islander |
0
0%
|
1
2.3%
|
1
2.4%
|
1
2.4%
|
0
0%
|
0
0%
|
3
1.2%
|
| White |
24
66.7%
|
31
72.1%
|
29
69%
|
30
71.4%
|
32
74.4%
|
28
68.3%
|
174
70.4%
|
| Multiple Race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.4%
|
1
0.4%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
11
30.6%
|
17
39.5%
|
12
28.6%
|
18
42.9%
|
16
37.2%
|
19
46.3%
|
93
37.7%
|
| Mexico |
2
5.6%
|
4
9.3%
|
1
2.4%
|
4
9.5%
|
2
4.7%
|
4
9.8%
|
17
6.9%
|
| Spain |
0
0%
|
0
0%
|
1
2.4%
|
1
2.4%
|
2
4.7%
|
0
0%
|
4
1.6%
|
| Ukraine |
4
11.1%
|
4
9.3%
|
9
21.4%
|
5
11.9%
|
7
16.3%
|
5
12.2%
|
34
13.8%
|
| Romania |
4
11.1%
|
5
11.6%
|
6
14.3%
|
5
11.9%
|
3
7%
|
1
2.4%
|
24
9.7%
|
| Austria |
4
11.1%
|
2
4.7%
|
0
0%
|
1
2.4%
|
0
0%
|
0
0%
|
7
2.8%
|
| South Africa |
10
27.8%
|
8
18.6%
|
10
23.8%
|
6
14.3%
|
8
18.6%
|
7
17.1%
|
49
19.8%
|
| Germany |
1
2.8%
|
2
4.7%
|
3
7.1%
|
2
4.8%
|
5
11.6%
|
4
9.8%
|
17
6.9%
|
| United Kingdom |
0
0%
|
1
2.3%
|
0
0%
|
0
0%
|
0
0%
|
1
2.4%
|
2
0.8%
|
Outcome Measures
| Title | Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint |
|---|---|
| Description | LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 34 | 34 | 39 | 32 | 35 | 32 |
| Least Squares Mean (95% Confidence Interval) [percentage of glycosylated hemoglobin] |
-0.60
|
-0.80
|
-1.24
|
-1.41
|
-1.37
|
-0.13
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0109 |
| Comments | p-value represents change from baseline to Week 12 HbA1c for 0.5 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant. | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.47 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to -0.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | p-value represents change from baseline to week 12 HbA1c for 2.0 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant. | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.67 | |
| Confidence Interval |
(2-Sided) 95% -1.02 to -0.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 HbA1c for 6.2 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant. | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -1.11 | |
| Confidence Interval |
(2-Sided) 95% -1.46 to -0.76 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 HbA1c for 12.0 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant. | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -1.28 | |
| Confidence Interval |
(2-Sided) 95% -1.64 to -0.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 HbA1c for 17.6 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant. | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -1.24 | |
| Confidence Interval |
(2-Sided) 95% -1.59 to -0.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint |
|---|---|
| Description | The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 34 | 34 | 38 | 34 | 35 | 34 |
| Hunger |
-2.28
(3.05)
|
-0.85
(3.03)
|
-3.76
(2.88)
|
-0.92
(3.04)
|
-1.37
(3.00)
|
-4.22
(3.05)
|
| How Full |
13.32
(3.53)
|
3.04
(3.48)
|
5.98
(3.33)
|
2.38
(3.50)
|
4.41
(3.44)
|
10.43
(3.49)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.655 |
| Comments | p-value represents change from baseline to Week 12 for hunger, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 1.93 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.436 |
| Comments | p-value represents change from baseline to Week 12 for hunger, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 3.36 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.914 |
| Comments | p-value represents change from baseline to Week 12 for hunger, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 0.45 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.446 |
| Comments | p-value represents change from baseline to Week 12 for hunger, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 3.30 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.508 |
| Comments | p-value represents change from baseline to Week 12 for hunger, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 2.84 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.561 |
| Comments | p-value represents change from baseline to Week 12 for how full, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 2.89 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.135 |
| Comments | p-value represents change from baseline to Week 12 for how full, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -7.40 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.357 |
| Comments | p-value represents change from baseline to Week 12 for how full, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -4.45 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.105 |
| Comments | p-value represents change from baseline to Week 12 for how full, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -8.05 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.221 |
| Comments | p-value represents change from baseline to Week 12 for how full, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -6.02 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study |
|---|---|
| Description | Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary. |
| Time Frame | baseline through 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 36 | 43 | 42 | 42 | 43 | 41 |
| Number [participants] |
1
2.8%
|
2
4.7%
|
1
2.4%
|
3
7.1%
|
2
4.7%
|
1
2.4%
|
| Title | Total Average Concentration (Cavg) of LY2428757 |
|---|---|
| Description | Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval). |
| Time Frame | 4 weeks, 6 weeks, 8 weeks, 10 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 34 | 34 | 39 | 32 | 35 | 32 |
| Number [nanograms per milliliter (ng/mL)] |
29.5
|
118
|
453
|
877
|
1290
|
0
|
| Title | Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint |
|---|---|
| Description | Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 30 | 29 | 36 | 30 | 31 | 29 |
| Fasting |
-2.14
|
-17.08
|
-30.13
|
-28.05
|
-32.85
|
2.39
|
| 2 Hours Post Breakfast (n=29, 28, 34,28 30,29) |
-7.85
|
-32.25
|
-45.02
|
-45.58
|
-53.91
|
-2.53
|
| Prior to Lunch (n=29, 27, 34, 28, 29, 28) |
-6.22
|
-7.92
|
-25.42
|
-22.09
|
-26.37
|
13.98
|
| 2 Hours Post Lunch (n=28, 27, 35, 28, 30, 29) |
-17.71
|
-23.79
|
-44.43
|
-35.97
|
-54.77
|
-11.30
|
| Prior to Dinner (n=29, 27, 35, 28, 29, 29) |
-24.25
|
-33.82
|
-38.10
|
-39.90
|
-45.82
|
0.45
|
| 2 Hours Post Dinner (n=29, 28, 35, 29, 29, 29) |
-13.35
|
-22.63
|
-36.70
|
-31.10
|
-51.41
|
-1.51
|
| Prior to Bed (n=27, 23, 33, 25, 29, 25) |
-12.33
|
-24.08
|
-26.48
|
-29.05
|
-41.48
|
11.69
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4848 |
| Comments | p-value represents change from baseline to Week 12 for fasting glucose, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -4.54 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0029 |
| Comments | p-value represents change from baseline to Week 12 for fasting glucose, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -19.48 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for fasting glucose, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -32.52 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for fasting glucose, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -30.45 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for fasting glucose, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -35.25 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6279 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -5.32 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0072 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -29.72 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -42.49 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -43.05 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -51.38 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0335 |
| Comments | p-value represents change from baseline to Week 12 for prior to lunch glucose, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -20.21 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0221 |
| Comments | p-value represents change from baseline to Week 12 for prior to lunch glucose, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -21.91 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for prior to lunch glucose, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -39.41 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | p-value represents change from baseline to Week 12 for prior to lunch glucose, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -36.07 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for prior to lunch glucose, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -40.36 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5030 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -6.41 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1938 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -12.49 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -33.13 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0101 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -24.66 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -43.47 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0060 |
| Comments | p-value represents change from baseline to Week 12 for prior to dinner glucose, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -24.69 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | p-value represents change from baseline to Week 12 for prior to dinner glucose, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -34.26 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for prior to dinner glucose, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -38.55 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for prior to dinner glucose, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -40.34 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for prior to dinner glucose, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -46.26 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2468 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -11.84 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0413 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, visit, treatment and visit by treatment interaction as fixed effects | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -21.13 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0004 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -35.19 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0040 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -29.59 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -49.90 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0199 |
| Comments | p-value represents change from baseline to Week 12 for prior to bed glucose, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -24.02 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0008 |
| Comments | p-value represents change from baseline to Week 12 for prior to bed glucose, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -35.77 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | p-value represents change from baseline to Week 12 for prior to bed glucose, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -38.17 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | p-value represents change from baseline to Week 12 for prior to bed glucose, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -40.74 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 for prior to bed glucose, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -53.16 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint |
|---|---|
| Description | An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 30 | 28 | 35 | 27 | 32 | 29 |
| Least Squares Mean (95% Confidence Interval) [milligrams per minute per deciliter] |
-1370.49
|
-1709.67
|
-5786.59
|
-6354.83
|
-8025.33
|
-238.64
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4193 |
| Comments | p-value represents change from baseline to Week 12 total glucose AUC for 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -1131.85 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3026 |
| Comments | p-value represents change from baseline to Week 12 total glucose AUC for 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -1471.04 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 total glucose AUC for 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -5547.95 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 total glucose AUC for 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -6116.19 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | p-value represents change from baseline to Week 12 total glucose AUC for 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -7786.69 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint |
|---|---|
| Description | An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 23 | 23 | 32 | 23 | 27 | 27 |
| Least Squares Mean (95% Confidence Interval) [picomole per minute per liter] |
3111.25
|
3984.37
|
12521.89
|
14179.28
|
8778.23
|
3540.52
|
| Title | Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint |
|---|---|
| Description | An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 29 | 27 | 33 | 27 | 30 | 30 |
| Least Squares Mean (95% Confidence Interval) [picomole per minute per liter] |
-683.72
|
31434.85
|
49370.53
|
46280.14
|
22012.58
|
8714.30
|
| Title | Change in Fasting Lipids From Baseline to Week 12 Endpoint |
|---|---|
| Description | Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. The last post-baseline measurement was carried forward if the value at week 12 was missing. |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 35 | 40 | 40 | 37 | 41 | 37 |
| Triglycerides (n=35, 40, 40, 37, 41, 37) |
-0.15
(0.139)
|
0.08
(0.130)
|
-0.35
(0.130)
|
-0.31
(0.135)
|
-0.31
(0.128)
|
-0.22
(0.135)
|
| HDL (n=35, 38, 39, 31, 39, 34) |
0.02
(0.034)
|
-0.03
(0.032)
|
-0.03
(0.032)
|
-0.03
(0.036)
|
0.02
(0.032)
|
0.01
(0.034)
|
| LDL (n=35, 37, 39, 31, 39, 34) |
0.0
(0.09)
|
-0.1
(0.09)
|
-0.1
(0.09)
|
0.0
(0.10)
|
-0.1
(0.09)
|
0.1
(0.09)
|
| Total cholesterol (n=35, 38, 39, 31, 39, 34) |
-0.10
(0.104)
|
-0.01
(0.100)
|
-0.30
(0.098)
|
-0.10
(0.112)
|
-0.25
(0.099)
|
0.02
(0.105)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.693 |
| Comments | p-value represents change from baseline to Week 12 for fasting triglycerides, 0.5 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 0.08 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.104 |
| Comments | p-value represents change from baseline to Week 12 for fasting triglycerides, 2.0 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 0.31 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.506 |
| Comments | p-value represents change from baseline to Week 12 for fasting triglycerides, 6.2 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.13 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.648 |
| Comments | p-value represents change from baseline to Week 12 for fasting triglycerides, 12.0 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.09 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.647 |
| Comments | p-value represents change from baseline to Week 12 for fasting triglycerides, 17.6 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.09 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.781 |
| Comments | p-value represents change from baseline to Week 12 for fasting HDL, 0.5 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 0.01 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.401 |
| Comments | p-value represents change from baseline to Week 12 for fasting HDL, 2.0 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.04 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.464 |
| Comments | p-value represents change from baseline to Week 12 for fasting HDL, 6.2 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.03 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.420 |
| Comments | p-value represents change from baseline to Week 12 for fasting HDL, 12.0 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.04 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.762 |
| Comments | p-value represents change from baseline to Week 12 for fasting HDL, 17.6 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | 0.01 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.738 |
| Comments | p-value represents change from baseline to Week 12 for fasting LDL, 0.5 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.04 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.277 |
| Comments | p-value represents change from baseline to Week 12 for fasting LDL, 2.0 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.14 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.094 |
| Comments | p-value represents change from baseline to Week 12 for fasting LDL, 6.2 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.21 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.792 |
| Comments | p-value represents change from baseline to Week 12 for fasting LDL, 12.0 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.04 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.105 |
| Comments | p-value represents change from baseline to Week 12 for fasting LDL, 17.6 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.21 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.403 |
| Comments | p-value represents change from baseline to Week 12 for fasting total cholesterol, 0.5 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.12 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.799 |
| Comments | p-value represents change from baseline to Week 12 for fasting total cholesterol, 2.0 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.04 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.029 |
| Comments | p-value represents change from baseline to Week 12 for fasting total cholesterol, 6.2 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.32 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.439 |
| Comments | p-value represents change from baseline to Week 12 for fasting total cholesterol, 12.0 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.12 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.062 |
| Comments | p-value represents change from baseline to Week 12 for fasting total cholesterol, 17.6 mg treatment arm in comparison to placebo | |
| Method | ANCOVA | |
| Comments | ANCOVA: baseline and treatment | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.27 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Fasting Weight From Baseline to Week 12 Endpoint |
|---|---|
| Description | LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 35 | 36 | 40 | 36 | 35 | 34 |
| Least Squares Mean (95% Confidence Interval) [kilograms (kg)] |
-0.75
|
-0.85
|
-2.12
|
-1.03
|
-2.60
|
-0.59
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 0.5 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8003 |
| Comments | p-value represents change from baseline to Week 12 for fasting weight, 0.5 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.16 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 2.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6736 |
| Comments | p-value represents change from baseline to Week 12 for fasting weight, 2.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.26 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 6.2 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0123 |
| Comments | p-value represents change from baseline to Week 12 for fasting weight, 6.2 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -1.53 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 12.0 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4771 |
| Comments | p-value represents change from baseline to Week 12 for fasting weight, 12.0 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -0.44 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 17.6 mg LY2428757, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0013 |
| Comments | p-value represents change from baseline to Week 12 for fasting weight, 17.6 mg treatment arm in comparison to placebo | |
| Method | Mixed Models Analysis | |
| Comments | Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction | |
| Method of Estimation | Estimation Parameter | Difference in mean change from baseline |
| Estimated Value | -2.01 | |
| Confidence Interval |
() 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint |
|---|---|
| Description | Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12) |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 35 | 39 | 40 | 38 | 40 | 37 |
| Least Squares Mean (Standard Error) [units on a scale] |
0.2
(0.22)
|
-0.1
(0.20)
|
0.3
(0.21)
|
0.2
(0.21)
|
0.1
(0.21)
|
0.2
(0.21)
|
| Title | Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint |
|---|---|
| Description | DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12) |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 35 | 39 | 40 | 37 | 40 | 38 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.3
(0.30)
|
-0.1
(0.28)
|
-0.9
(0.28)
|
-0.4
(0.29)
|
-0.3
(0.29)
|
-0.7
(0.28)
|
| Title | Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint |
|---|---|
| Description | Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment. |
| Time Frame | baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12) |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 35 | 39 | 40 | 38 | 40 | 37 |
| Least Squares Mean (Standard Error) [millimeters] |
6.9
(2.59)
|
6.2
(2.33)
|
6.0
(2.41)
|
6.0
(2.46)
|
7.1
(2.47)
|
2.7
(2.48)
|
| Title | Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint |
|---|---|
| Description | The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant. |
| Time Frame | Baseline, 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Measure Participants | 36 | 42 | 42 | 39 | 42 | 40 |
| Mobility-Baseline |
88.9
246.9%
|
73.8
171.6%
|
76.2
181.4%
|
84.6
201.4%
|
81.0
188.4%
|
75.0
182.9%
|
| Mobility-Endpoint |
94.3
261.9%
|
77.8
180.9%
|
90.0
214.3%
|
77.8
185.2%
|
88.6
206%
|
85.3
208%
|
| Self Care-Baseline |
97.2
270%
|
97.6
227%
|
90.5
215.5%
|
94.9
226%
|
95.2
221.4%
|
97.5
237.8%
|
| Self Care- Endpoint |
94.3
261.9%
|
97.2
226%
|
100.0
238.1%
|
94.4
224.8%
|
100.0
232.6%
|
97.1
236.8%
|
| Usual Activities- Baseline |
80.6
223.9%
|
81.0
188.4%
|
83.3
198.3%
|
87.2
207.6%
|
81.0
188.4%
|
75.0
182.9%
|
| Usual Activities- Endpoint |
91.4
253.9%
|
88.9
206.7%
|
90.0
214.3%
|
91.7
218.3%
|
97.1
225.8%
|
88.2
215.1%
|
| Pain/Discomfort- Baseline |
61.1
169.7%
|
59.5
138.4%
|
54.8
130.5%
|
59.0
140.5%
|
54.8
127.4%
|
52.5
128%
|
| Pain/Discomfort- Endpoint |
60.0
166.7%
|
52.8
122.8%
|
70.0
166.7%
|
63.9
152.1%
|
71.4
166%
|
61.8
150.7%
|
| Anxiety/Depression- Baseline |
66.7
185.3%
|
64.3
149.5%
|
73.8
175.7%
|
74.4
177.1%
|
66.7
155.1%
|
70.0
170.7%
|
| Anxiety/Depression- Endpoint |
68.6
190.6%
|
69.4
161.4%
|
87.5
208.3%
|
77.8
185.2%
|
74.3
172.8%
|
70.6
172.2%
|
Adverse Events
| Time Frame | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The safety population includes all randomized participants who received at least one administration of study medication. | |||||||||||
| Arm/Group Title | 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo | ||||||
| Arm/Group Description | Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. | ||||||
All Cause Mortality |
||||||||||||
| 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/36 (2.8%) | 4/42 (9.5%) | 1/42 (2.4%) | 1/41 (2.4%) | 0/43 (0%) | 0/40 (0%) | ||||||
| Cardiac disorders | ||||||||||||
| Acute myocardial infarction | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Atrial fibrillation | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Crohn's disease | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Urinary tract infection | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Hypoglycaemia | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Squamous cell carcinoma | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Chronic obstructive pulmonary disease | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| 0.5 mg LY2428757 | 2.0 mg LY2428757 | 6.2 mg LY2428757 | 12.0 mg LY2428757 | 17.6 mg LY2428757 | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/36 (52.8%) | 25/42 (59.5%) | 26/42 (61.9%) | 24/41 (58.5%) | 28/43 (65.1%) | 23/40 (57.5%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Leukocytosis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| Angina pectoris | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Atrial fibrillation | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Atrioventricular block first degree | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Myocardial ischaemia | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Ventricular extrasystoles | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||||||
| Ear pain | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Tympanic membrane disorder | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Vertigo | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Eye disorders | ||||||||||||
| Conjunctivitis | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Conjunctivitis allergic | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Vision blurred | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 2/40 (5%) | 2 |
| Visual acuity reduced | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Visual disturbance | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal discomfort | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Abdominal distension | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 2/43 (4.7%) | 2 | 0/40 (0%) | 0 |
| Abdominal pain | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 2/42 (4.8%) | 2 | 1/41 (2.4%) | 1 | 2/43 (4.7%) | 3 | 0/40 (0%) | 0 |
| Abdominal pain lower | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Abdominal pain upper | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 1/43 (2.3%) | 2 | 0/40 (0%) | 0 |
| Abdominal rigidity | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 2/41 (4.9%) | 3 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Constipation | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 2/42 (4.8%) | 2 | 2/41 (4.9%) | 2 | 5/43 (11.6%) | 7 | 1/40 (2.5%) | 1 |
| Crohn's disease | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Diarrhoea | 3/36 (8.3%) | 3 | 3/42 (7.1%) | 3 | 4/42 (9.5%) | 7 | 7/41 (17.1%) | 9 | 3/43 (7%) | 4 | 3/40 (7.5%) | 6 |
| Dry mouth | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Dyspepsia | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 3/42 (7.1%) | 5 | 3/41 (7.3%) | 5 | 6/43 (14%) | 9 | 0/40 (0%) | 0 |
| Eructation | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 3 | 2/43 (4.7%) | 2 | 0/40 (0%) | 0 |
| Flatulence | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Food poisoning | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Frequent bowel movements | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Gastritis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 2/43 (4.7%) | 2 | 1/40 (2.5%) | 1 |
| Nausea | 1/36 (2.8%) | 2 | 6/42 (14.3%) | 6 | 9/42 (21.4%) | 21 | 13/41 (31.7%) | 18 | 16/43 (37.2%) | 29 | 6/40 (15%) | 6 |
| Pancreatitis acute | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Toothache | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Vomiting | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 4/41 (9.8%) | 4 | 7/43 (16.3%) | 12 | 1/40 (2.5%) | 1 |
| General disorders | ||||||||||||
| Asthenia | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 1/40 (2.5%) | 2 |
| Chest pain | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Cyst rupture | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Early satiety | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Fatigue | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 2/43 (4.7%) | 2 | 1/40 (2.5%) | 1 |
| Injection site bruising | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/43 (2.3%) | 3 | 0/40 (0%) | 0 |
| Injection site haematoma | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Injection site irritation | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/43 (2.3%) | 3 | 0/40 (0%) | 0 |
| Injection site pain | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 2 | 1/43 (2.3%) | 1 | 2/40 (5%) | 2 |
| Injection site pruritus | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Injection site reaction | 1/36 (2.8%) | 1 | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 2 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Local swelling | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Malaise | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Oedema peripheral | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Pyrexia | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Thirst | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Vessel puncture site haematoma | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 2 | 0/40 (0%) | 0 |
| Immune system disorders | ||||||||||||
| Seasonal allergy | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Infections and infestations | ||||||||||||
| Bronchitis | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Cellulitis | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Diverticulitis | 0/36 (0%) | 0 | 1/42 (2.4%) | 2 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Ear infection | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Gastroenteritis | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Herpes zoster | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 1/40 (2.5%) | 1 |
| Influenza | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Nasopharyngitis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 2/42 (4.8%) | 2 | 2/41 (4.9%) | 2 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Oral herpes | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Pharyngitis | 1/36 (2.8%) | 1 | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Pharyngotonsillitis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Rash pustular | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Respiratory tract infection viral | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 2/42 (4.8%) | 2 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Rhinitis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Sinusitis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Tonsillitis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Upper respiratory tract infection | 1/36 (2.8%) | 1 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Urinary tract infection | 1/36 (2.8%) | 1 | 2/42 (4.8%) | 2 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 1/43 (2.3%) | 1 | 1/40 (2.5%) | 1 |
| Viral upper respiratory tract infection | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||
| Contusion | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Limb injury | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Skin laceration | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Thermal burn | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Wound | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Investigations | ||||||||||||
| Alanine aminotransferase increased | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Aspartate aminotransferase increased | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Blood calcitonin increased | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Blood calcium increased | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Blood creatine phosphokinase increased | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Blood creatinine increased | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Blood glucose increased | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Blood pressure increased | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Blood triglycerides increased | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Blood urine present | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Electrocardiogram qt prolonged | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Gamma-glutamyltransferase increased | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Haematocrit decreased | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Haemoglobin decreased | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Lipase increased | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 2/43 (4.7%) | 2 | 0/40 (0%) | 0 |
| Protein urine | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Anorexia | 1/36 (2.8%) | 2 | 2/42 (4.8%) | 2 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 3/40 (7.5%) | 3 |
| Decreased appetite | 0/36 (0%) | 0 | 2/42 (4.8%) | 3 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 2/43 (4.7%) | 4 | 1/40 (2.5%) | 1 |
| Diabetes mellitus inadequate control | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Hypertriglyceridaemia | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Hypoglycaemia | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 2/36 (5.6%) | 2 | 2/42 (4.8%) | 2 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Back pain | 0/36 (0%) | 0 | 3/42 (7.1%) | 3 | 2/42 (4.8%) | 2 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Joint swelling | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Muscle spasms | 2/36 (5.6%) | 2 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 2/43 (4.7%) | 2 | 1/40 (2.5%) | 1 |
| Musculoskeletal chest pain | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Musculoskeletal pain | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Myalgia | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Osteoarthritis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Pain in extremity | 0/36 (0%) | 0 | 2/42 (4.8%) | 2 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Temporomandibular joint syndrome | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Tenosynovitis | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Basal cell carcinoma | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Haemangioma | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Melanocytic naevus | 0/36 (0%) | 0 | 1/42 (2.4%) | 2 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Skin papilloma | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Squamous cell carcinoma | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Burning sensation | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Dizziness | 1/36 (2.8%) | 1 | 1/42 (2.4%) | 1 | 2/42 (4.8%) | 2 | 2/41 (4.9%) | 2 | 2/43 (4.7%) | 2 | 2/40 (5%) | 2 |
| Dysgeusia | 1/36 (2.8%) | 2 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Headache | 2/36 (5.6%) | 3 | 3/42 (7.1%) | 5 | 2/42 (4.8%) | 3 | 5/41 (12.2%) | 5 | 4/43 (9.3%) | 4 | 2/40 (5%) | 2 |
| Hypoaesthesia | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Lethargy | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Neuritis | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Paraesthesia | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Polyneuropathy | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Sciatica | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Somnolence | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 1/40 (2.5%) | 1 |
| Syncope | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Syncope vasovagal | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Tremor | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 2/42 (4.8%) | 4 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Psychiatric disorders | ||||||||||||
| Depression | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Insomnia | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| Dysuria | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Haematuria | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Nocturia | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Renal pain | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 1/40 (2.5%) | 1 |
| Reproductive system and breast disorders | ||||||||||||
| Pelvic pain | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Uterine cyst | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Chronic obstructive pulmonary disease | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 2/40 (5%) | 2 |
| Cough | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 2/40 (5%) | 2 |
| Nasal congestion | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Pharyngolaryngeal pain | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Dandruff | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Dermal cyst | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Dermatitis | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Dermatitis allergic | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Dermatitis contact | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Dermatosis | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Eczema | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Erythema | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Hyperkeratosis | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Ingrowing nail | 1/36 (2.8%) | 1 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Pruritus | 1/36 (2.8%) | 1 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Rash | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
| Skin lesion | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Swelling face | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Vascular disorders | ||||||||||||
| Circulatory collapse | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Haematoma | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 2 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Hot flush | 0/36 (0%) | 0 | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Hypertension | 0/36 (0%) | 0 | 5/42 (11.9%) | 6 | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Hypotension | 0/36 (0%) | 0 | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/43 (0%) | 0 | 0/40 (0%) | 0 |
| Orthostatic hypotension | 1/36 (2.8%) | 1 | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/43 (2.3%) | 1 | 0/40 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00804986
Other Study ID Numbers:
- 12134
- I1I-MC-GECD
- CTRI/2009/091/000091
First Posted:
Dec 9, 2008
Last Update Posted:
Jul 14, 2011
Last Verified:
Jul 1, 2011