A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
Study Details
Study Description
Brief Summary
The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Insulin Peglispro Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs). |
Drug: Insulin Peglispro
Administered SC using a prefilled pen.
Other Names:
Drug: Oral Antihyperglycemic Medications (OAMs)
Administered orally
Other Names:
|
| Active Comparator: Insulin Glargine Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs. |
Drug: Insulin Glargine
Administered SC using a prefilled pen
Drug: Oral Antihyperglycemic Medications (OAMs)
Administered orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) [Baseline, Week 26]
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein [LDL-C], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.
Secondary Outcome Measures
- 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events [Baseline to Week 26]
Hypoglycemia Events (HE) occurs when blood glucose level ≤ 70 milligram per deciliter (mg/dL) (<3.9 micromoles per liter [mmol/L]). Nocturnal HE includes any total HE that occurred between bedtime and waking. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline total hypoglycemia event rate, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
- Fasting Serum Glucose (FSG) [Weeks 0 and 26]
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and sulfonylurea [SU]/meglitinide use), visit, and treatment-by-visit interaction.
- Fasting Blood Glucose (FBG) [Weeks 0 and 26]
LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.
- Change From Baseline to Week 26 in Body Weight [Baseline, Week 26]
LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.
- 9-Point Self-Monitored Blood Glucose (SMBG) [Week 0 and Week 26]
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. The 9-point SMBG are measured at: Pre-morning meal, 2 hours(hr) post morning meal, pre-midday meal, 2 hr post midday meal, pre-evening meal, 2 hr post pre-evening meal, bedtime, 0300 hr, and pre-morning meal next day, and should be performed on 2 non-consecutive days.
- Percentage of Participants With HbA1c ≤6.5% [Week 26]
Percentage of participants with HbA1c ≤6.5% at Week 26 were made using a logistic regression model for endpoint used last observation carried forward (LOCF) method including treatment, baseline HbA1c value.
- Insulin Dose Per Kilogram (kg) of Body Weight [Week 26]
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide), visit, and treatment-by-visit interaction.
- Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose]) [Week 26]
- Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26 [Week 26]
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit, and treatment-by-visit interaction.
- Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26 [Week 26]
For participants with detectable anti-insulin peglispro antibody level, the percentage of participants with positive cross-react with endogenous insulin was summarized.
- Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26 [Baseline, Week 26]
The EuroQoL-5D-3L questionnaire 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 anxiety/depression using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. Overall health state score was self-reported using a VAS marked on a scale of 0 to 100 (0 indicates worst imaginable health state and 100 indicates best imaginable health state. LS means were calculated using analysis of covariance (ANCOVA) for actual measures and changes from baseline at endpoint using LOCF method: adjusting for treatment, stratification factors (region, HbA1c and SU/meglitin.
- Insulin Treatment Satisfaction Questionnaire (ITSQ) Score [Week 4 and 26]
The Insulin Treatment Satisfaction Questionnaire is a validated instrument containing 22 items that assessed treatment satisfaction for participants with diabetes on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means was achieved using a MMRM model for post-baseline measures with stratification factors (country, HbA1c, and SU/meglitinide use) treatment, visit, treatment-by-visit as fixed effects. ITSQ was assessed at Week 4 (baseline) and Week 26.
- Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores [Baseline, Week 26]
LBSS is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 5 - always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range 0 to 132). Higher total scores reflect greater fear of hypoglycemia. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. LBSS was assessed during screening visit (baseline) and again at Week 26.
- Intra-Participant Variability of the Fasting Blood Glucose (FBG) [Week 26]
Intra-participant variability of Fasting Blood Glucose (FBG), which was measured by Self Monitored Blood Glucose (SMBG), was assessed by the standard deviation of the FBG measurement at the Week 26 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
- Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c) [Baseline, Week 12]
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months.LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
- Percent Hemoglobin A1c at Week 26 [Week 26]
HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
- Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE) [Baseline to Week 26]
Percentage of participants with hypoglycemic events (total or nocturnal) to Week 26 based on BG Threshold 70mg/dL.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin
-
Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening
-
Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central laboratory at screening
-
Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m^2)
-
Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG)
-
Record keeping as required by this protocol
-
Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening, do not plan to become pregnant during the study, have practiced reliable birth control during the study and 2 weeks following the last dose of investigational product
Exclusion Criteria:
-
Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions
-
Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months prior to screening
-
Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
-
Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
-
Are taking, or have taken within 3 months before screening, prescription or over-the-counter medications to promote weight loss
-
Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
-
Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6 months
-
Have cardiac disease with functional status that is New York Heart Association Class III or IV
-
Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2.0 milligram per deciliter (mg/dL) (177 micromole per liter [μmol/L]). Participants taking metformin should not exceed the creatinine level specified in the local label
-
Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or any chronic hepatitis, non alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
-
Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
-
Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
-
Have known hypersensitivity or allergy to any of LY2605541 and insulin glargine or their excipients
-
Have pre proliferative and proliferative retinopathy, maculopathy requiring treatment or not clinically stable in the last 6 months, or participants with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months
-
Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
-
Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening as determined by the central laboratory
-
Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
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. | Aichi | Japan | 455-8530 | |
| 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. | Chiba | Japan | 277-0825 | |
| 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. | Fukuoka | Japan | 807-0857 | |
| 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. | Hokkaido | Japan | 060-0062 | |
| 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. | Hyogo | Japan | 662-0971 | |
| 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. | Ibaraki | Japan | 311-0113 | |
| 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. | Kagawa | Japan | 765-0071 | |
| 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. | Kanagawa | Japan | 247-0056 | |
| 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. | Kumamoto | Japan | 862-0976 | |
| 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. | Kyoto | Japan | 6150035 | |
| 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. | Miyagi | Japan | 980-0021 | |
| 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. | Miyazaki | Japan | 880-0034 | |
| 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. | Nagano | Japan | 399-0006 | |
| 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. | Ooita | Japan | 8700039 | |
| 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. | Osaka | Japan | 569-1096 | |
| 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. | Tochigi | Japan | 323-0022 | |
| 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. | Tokyo | Japan | 143-8541 | |
| 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. | Yamaguchi | Japan | 751-0815 | |
| 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. | Daegu | Korea, Republic of | 700-712 | |
| 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. | Incheon | Korea, Republic of | 405-760 | |
| 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. | Pusan | Korea, Republic of | 602-739 | |
| 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. | Seoul | Korea, Republic of | 158-710 | |
| 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. | Ulsan-Si | Korea, Republic of | 682-714 | |
| 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. | Wonju-Si | Korea, Republic of | 220-701 | |
| 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. | Jhonghe City | Taiwan | 235 | |
| 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. | Sindian City | Taiwan | 23148 | |
| 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. | Taichung County | Taiwan | 433 | |
| 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. | Taichung | Taiwan | 404 | |
| 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. | Tainan | Taiwan | 70403 | |
| 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. | Taipei | Taiwan | 220 | |
| 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. | Yongkang City | Taiwan | 71004 |
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.- 13422
- I2R-JE-BIAQ
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Period Title: Overall Study | ||
| STARTED | 192 | 196 |
| Received at Least 1 Dose of Study Drug | 192 | 196 |
| COMPLETED | 182 | 186 |
| NOT COMPLETED | 10 | 10 |
Baseline Characteristics
| Arm/Group Title | Insulin Peglispro | Insulin Glargine | Total |
|---|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. | Total of all reporting groups |
| Overall Participants | 192 | 196 | 388 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
141
73.4%
|
153
78.1%
|
294
75.8%
|
| >=65 years |
51
26.6%
|
43
21.9%
|
94
24.2%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
81
42.2%
|
90
45.9%
|
171
44.1%
|
| Male |
111
57.8%
|
106
54.1%
|
217
55.9%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
192
100%
|
196
100%
|
388
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| Japan |
103
53.6%
|
102
52%
|
205
52.8%
|
| Taiwan |
40
20.8%
|
42
21.4%
|
82
21.1%
|
| South Korea |
49
25.5%
|
52
26.5%
|
101
26%
|
| Baseline Hemoglobin A1c (HbA1c) (percent of HbA1c) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [percent of HbA1c] |
8.59
(1.09)
|
8.48
(0.85)
|
8.53
(0.97)
|
| Fasting Serum Glucose (FSG) (milligram per deciliter (mg/dL)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [milligram per deciliter (mg/dL)] |
165.11
(41.25)
|
166.64
(36.81)
|
165.88
(39.03)
|
Outcome Measures
| Title | Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) |
|---|---|
| Description | Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein [LDL-C], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C. |
| Time Frame | Baseline, Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 179 | 184 |
| Least Squares Mean (Standard Error) [percent of HbA1c] |
-1.61
(0.06)
|
-1.36
(0.06)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Peglispro, Insulin Glargine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | 0.4% is the margin of Non-inferiority | |
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.41 to -0.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events |
|---|---|
| Description | Hypoglycemia Events (HE) occurs when blood glucose level ≤ 70 milligram per deciliter (mg/dL) (<3.9 micromoles per liter [mmol/L]). Nocturnal HE includes any total HE that occurred between bedtime and waking. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline total hypoglycemia event rate, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. |
| Time Frame | Baseline to Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable HE data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 192 | 196 |
| Total HE |
1.28
(0.23)
|
1.21
(0.23)
|
| Nocturnal HE |
0.19
(0.12)
|
0.27
(0.18)
|
| Title | Fasting Serum Glucose (FSG) |
|---|---|
| Description | LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and sulfonylurea [SU]/meglitinide use), visit, and treatment-by-visit interaction. |
| Time Frame | Weeks 0 and 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable FSG data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 191 | 194 |
| Week 0 |
164.31
(2.78)
|
166.61
(2.76)
|
| Week 26 |
103.85
(1.93)
|
110.32
(1.90)
|
| Title | Fasting Blood Glucose (FBG) |
|---|---|
| Description | LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. |
| Time Frame | Weeks 0 and 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable FBG data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 190 | 195 |
| Week 0 |
159.53
(2.51)
|
161.19
(2.48)
|
| Week 26 |
108.39
(1.58)
|
108.22
(1.55)
|
| Title | Change From Baseline to Week 26 in Body Weight |
|---|---|
| Description | LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. |
| Time Frame | Baseline, Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable body weight data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 190 | 193 |
| Least Squares Mean (Standard Error) [Kilogram (kg)] |
1.06
(0.16)
|
1.57
(0.16)
|
| Title | 9-Point Self-Monitored Blood Glucose (SMBG) |
|---|---|
| Description | LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. The 9-point SMBG are measured at: Pre-morning meal, 2 hours(hr) post morning meal, pre-midday meal, 2 hr post midday meal, pre-evening meal, 2 hr post pre-evening meal, bedtime, 0300 hr, and pre-morning meal next day, and should be performed on 2 non-consecutive days. |
| Time Frame | Week 0 and Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable SMBG data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 188 | 192 |
| Morning Pre-meal Wk0 |
160.19
(2.65)
|
162.83
(2.62)
|
| Morning Pre-meal Wk26 |
108.24
(1.68)
|
108.71
(1.65)
|
| Morning Post-meal Wk0 |
237.19
(4.26)
|
233.37
(4.21)
|
| Morning Post-meal Wk26 |
176.97
(3.31)
|
176.93
(3.23)
|
| Mid-day Pre-meal Wk0 |
169.24
(3.80)
|
166.68
(3.76)
|
| Mid-day Pre-meal Wk26 |
122.01
(2.56)
|
122.85
(2.50)
|
| Mid-day Post-meal Wk0 |
224.22
(4.23)
|
226.11
(4.21)
|
| Mid-day Post-meal Wk26 |
182.32
(3.26)
|
183.88
(3.18)
|
| Evening Pre-meal Wk0 |
176.49
(3.80)
|
172.83
(3.75)
|
| Evening Pre-meal Wk26 |
131.65
(3.08)
|
135.55
(2.99)
|
| Evening Post-meal Wk0 |
219.45
(4.20)
|
219.54
(4.16)
|
| Evening Post-meal Wk26 |
176.23
(3.37)
|
182.80
(3.26)
|
| Bed Time Wk0 |
198.64
(3.90)
|
197.68
(3.83)
|
| Bed Time Wk26 |
153.41
(2.95)
|
161.44
(2.87)
|
| 0300 Hours (Hrs) Wk0 |
158.82
(3.23)
|
162.13
(3.20)
|
| 0300 Hrs Wk26 |
115.18
(2.34)
|
114.77
(2.27)
|
| Pre-morning Meal Next Day Wk0 |
156.28
(2.57)
|
159.96
(2.55)
|
| Pre-morning Meal Next Day Wk26 |
108.42
(1.73)
|
105.18
(1.71)
|
| Title | Percentage of Participants With HbA1c ≤6.5% |
|---|---|
| Description | Percentage of participants with HbA1c ≤6.5% at Week 26 were made using a logistic regression model for endpoint used last observation carried forward (LOCF) method including treatment, baseline HbA1c value. |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 191 | 194 |
| Number [Percentage of participants] |
29.8
15.5%
|
22.7
11.6%
|
| Title | Insulin Dose Per Kilogram (kg) of Body Weight |
|---|---|
| Description | LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide), visit, and treatment-by-visit interaction. |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable insulin dose and body weight data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 191 | 195 |
| Least Squares Mean (Standard Error) [units per kg] |
0.26
(0.01)
|
0.26
(0.01)
|
| Title | Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose]) |
|---|---|
| Description | |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable insulin dose data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 192 | 196 |
| Number [percentage of participants] |
96.9
50.5%
|
97.2
49.6%
|
| Title | Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26 |
|---|---|
| Description | LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit, and treatment-by-visit interaction. |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable laboratory data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 192 | 196 |
| Cholesterol Wk26 |
175.76
(1.65)
|
177.90
(1.63)
|
| HDL Wk26 |
51.64
(0.49)
|
52.99
(0.48)
|
| Triglycerides Wk26 |
132.43
(4.71)
|
122.83
(4.65)
|
| LDL Wk26 |
97.95
(1.48)
|
101.07
(1.46)
|
| Title | Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26 |
|---|---|
| Description | For participants with detectable anti-insulin peglispro antibody level, the percentage of participants with positive cross-react with endogenous insulin was summarized. |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable antibody data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 192 | 196 |
| Number [percentage of participants] |
24.6
12.8%
|
32.5
16.6%
|
| Title | Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26 |
|---|---|
| Description | The EuroQoL-5D-3L questionnaire 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 anxiety/depression using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. Overall health state score was self-reported using a VAS marked on a scale of 0 to 100 (0 indicates worst imaginable health state and 100 indicates best imaginable health state. LS means were calculated using analysis of covariance (ANCOVA) for actual measures and changes from baseline at endpoint using LOCF method: adjusting for treatment, stratification factors (region, HbA1c and SU/meglitin. |
| Time Frame | Baseline, Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable EQ-5D data. Missing endpoints were imputed with last observation carried forward (LOCF). |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 184 | 192 |
| Change from Baseline to Endpoint EQ-5D-3L Score |
0.01
(0.01)
|
0.00
(0.01)
|
| Change from Baseline VAS Health State Score |
2.29
(0.92)
|
3.66
(0.90)
|
| Title | Insulin Treatment Satisfaction Questionnaire (ITSQ) Score |
|---|---|
| Description | The Insulin Treatment Satisfaction Questionnaire is a validated instrument containing 22 items that assessed treatment satisfaction for participants with diabetes on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means was achieved using a MMRM model for post-baseline measures with stratification factors (country, HbA1c, and SU/meglitinide use) treatment, visit, treatment-by-visit as fixed effects. ITSQ was assessed at Week 4 (baseline) and Week 26. |
| Time Frame | Week 4 and 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and have evaluable ITSQ data. Missing endpoints were imputed using last observation carried forward (LOCF). |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 188 | 192 |
| ITSQ Wk4 |
74.13
(1.04)
|
75.94
(1.03)
|
| ITSQ Wk26 |
78.73
(1.06)
|
78.29
(1.05)
|
| Title | Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores |
|---|---|
| Description | LBSS is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 5 - always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range 0 to 132). Higher total scores reflect greater fear of hypoglycemia. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. LBSS was assessed during screening visit (baseline) and again at Week 26. |
| Time Frame | Baseline, Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable LBSS data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 184 | 192 |
| Least Squares Mean (Standard Error) [units on a scale] |
1.51
(0.69)
|
1.62
(0.68)
|
| Title | Intra-Participant Variability of the Fasting Blood Glucose (FBG) |
|---|---|
| Description | Intra-participant variability of Fasting Blood Glucose (FBG), which was measured by Self Monitored Blood Glucose (SMBG), was assessed by the standard deviation of the FBG measurement at the Week 26 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and had at least 1 dose of study drug and had evaluable FBG data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 179 | 185 |
| Least Squares Mean (Standard Error) [mg/dL] |
14.97
(0.76)
|
15.12
(0.75)
|
| Title | Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c) |
|---|---|
| Description | Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months.LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 191 | 194 |
| Least Squares Mean (Standard Error) [percent of HbA1c] |
-1.43
(0.05)
|
-1.22
(0.05)
|
| Title | Percent Hemoglobin A1c at Week 26 |
|---|---|
| Description | HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 191 | 194 |
| Least Squares Mean (Standard Error) [percent of HbA1c] |
6.92
(0.06)
|
7.17
(0.06)
|
| Title | Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE) |
|---|---|
| Description | Percentage of participants with hypoglycemic events (total or nocturnal) to Week 26 based on BG Threshold 70mg/dL. |
| Time Frame | Baseline to Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least 1 dose of study drug and had evaluable HE data. |
| Arm/Group Title | Insulin Peglispro | Insulin Glargine |
|---|---|---|
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. |
| Measure Participants | 192 | 196 |
| Nocturnal Hypoglycemia BG 70mg/dL |
26.6
13.9%
|
29.6
15.1%
|
| Total Hypoglycemia BG 70mg/dL |
77.1
40.2%
|
76.5
39%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Insulin Peglispro | Insulin Glargine | ||
| Arm/Group Description | Insulin Peglispro administered SC once daily for 26 weeks. | Insulin Glargine administered SC once daily for 26 weeks. | ||
All Cause Mortality |
||||
| Insulin Peglispro | Insulin Glargine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Insulin Peglispro | Insulin Glargine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/192 (4.7%) | 5/196 (2.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Haemorrhagic diathesis | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Cardiac disorders | ||||
| Cardiac failure congestive | 0/192 (0%) | 0 | 1/196 (0.5%) | 1 |
| Eye disorders | ||||
| Glaucoma | 2/192 (1%) | 2 | 0/196 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Infections and infestations | ||||
| Diverticulitis | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Pneumonia | 0/192 (0%) | 0 | 1/196 (0.5%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 0/192 (0%) | 0 | 1/196 (0.5%) | 1 |
| Meniscus injury | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Radius fracture | 0/192 (0%) | 0 | 2/196 (1%) | 2 |
| Ulna fracture | 0/192 (0%) | 0 | 1/196 (0.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Haemarthrosis | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Intervertebral disc displacement | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Synovitis | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Renal and urinary disorders | ||||
| Nephrolithiasis | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Surgical and medical procedures | ||||
| Fracture treatment | 0/192 (0%) | 0 | 1/196 (0.5%) | 1 |
| Glaucoma surgery | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
| Suprapubic prostatectomy | 1/192 (0.5%) | 1 | 0/196 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Insulin Peglispro | Insulin Glargine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 61/192 (31.8%) | 42/196 (21.4%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 4/192 (2.1%) | 4 | 1/196 (0.5%) | 1 |
| Nausea | 6/192 (3.1%) | 7 | 1/196 (0.5%) | 1 |
| Infections and infestations | ||||
| Bronchitis | 4/192 (2.1%) | 4 | 4/196 (2%) | 5 |
| Gastroenteritis | 4/192 (2.1%) | 5 | 1/196 (0.5%) | 2 |
| Nasopharyngitis | 35/192 (18.2%) | 46 | 29/196 (14.8%) | 40 |
| Pharyngitis | 8/192 (4.2%) | 8 | 3/196 (1.5%) | 4 |
| Upper respiratory tract infection | 5/192 (2.6%) | 7 | 1/196 (0.5%) | 1 |
| Investigations | ||||
| Weight increased | 6/192 (3.1%) | 6 | 6/196 (3.1%) | 6 |
| Nervous system disorders | ||||
| Headache | 6/192 (3.1%) | 7 | 2/196 (1%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
- 13422
- I2R-JE-BIAQ