EGO: A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00630825
• Collaborator: (none)
• Enrollment: 262
• Locations: 34
• Arms: 4
• Duration (Months): 9
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2	Drug: LY2189265; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 262 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1.0/2.0 milligram (mg) LY2189265 LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	Drug: LY2189265; Other Names: Dulaglutide
Experimental: 1.0/1.0 milligram (mg) LY2189265 LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks	Drug: LY2189265; Other Names: Dulaglutide
Experimental: 0.5/1.0 milligram (mg) LY2189265 LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Drug: LY2189265; Other Names: Dulaglutide
Placebo Comparator: Placebo Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus [Baseline, 16 weeks]

   Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).

Secondary Outcome Measures

1. Change From Baseline in Fasting Blood Glucose [Baseline, 16 weeks]

   Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.

2. Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal) [Baseline and 16 weeks]

   Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie [Kcal], 103 grams [g] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting [0]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.

3. Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles [2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.]

   Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.

4. Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2) [Baseline, 16 weeks]

   Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.

5. Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5% [Baseline and 4 and 8 and 16 weeks]

   Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.

6. Change From Baseline in Body Weight [Baseline, 4, 8, and 16 weeks]

   LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.

7. Change From Baseline in Waist Circumference [Baseline, 16 weeks]

   Mean change from baseline in waist circumference (a measure of central obesity).

8. Nausea and Dyspepsia Measured by Visual Analog Scale [One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits]

   Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.

9. Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores [Baseline and 4 and 8 and 16 weeks]

   Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.

10. Number of Participants With a Hypoglycemic Event [Baseline through 4, 8, and 16 weeks]

    A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of <50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

11. Rate of Hypoglycemia Per 30 Days [Baseline through 16 weeks]

    Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

12. Change From Baseline in Lipids [Baseline, 16 weeks]

    Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.

13. Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire [Baseline and 4 and 8 and 16 weeks]

    The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6-point scale ranging from 1 "completely dissatisfied" to 6 "completely satisfied"; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 "all of the time" to 4 "none of the time"; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 "all of the time" to 4 "none of the time." These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized.

14. Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire [Baseline and 4 and 8 and 16 weeks]

    This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.

15. Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC) [Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks]

    The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 Diabetes Mellitus >3 months by history prior to entering the trial, based on disease diagnostic criteria from the American Diabetes Association (ADA 2007).

• Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.

• Have glycosylated hemoglobin (HbA1c) of >7.0% to ≤10.5% as determined by central laboratory at screening.

• Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m^2), inclusive.

• Have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4 (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).

Exclusion Criteria:

• Have known Type 1 Diabetes Mellitus

• Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)

• Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty [PTCA], open heart surgery, or coronary artery bypass graft [CABG]), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to screening.

• Have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) >2 milligrams per deciliter (mg/dL). If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be ≤1.5 mg/dL.

• Currently taking prescription or over the counter medications to prevent weight loss.

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.	Peoria	Arizona	United States	85381
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.	Anaheim	California	United States	92805
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.	Lancaster	California	United States	93534
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.	Northridge	California	United States	91326
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.	Palm Springs	California	United States	92262
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.	South Miami	Florida	United States	33143
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.	West Palm Beach	Florida	United States	33401
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.	Athens	Georgia	United States	30606
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.	Atlanta	Georgia	United States	30303
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.	Springfield	Illinois	United States	62704
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.	Indianapolis	Indiana	United States	46250
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.	Biddeford	Maine	United States	04005
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.	Ann Arbor	Michigan	United States	48108
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.	Bloomfield Hills	Michigan	United States	48302
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.	St Louis	Missouri	United States	63141
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.	Billings	Montana	United States	59101
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.	Flemington	New Jersey	United States	08822
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.	Syracuse	New York	United States	13210
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.	Greensboro	North Carolina	United States	27401
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.	Greenville	North Carolina	United States	27834
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.	Morehead City	North Carolina	United States	28557
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.	Memphis	Tennessee	United States	38119
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.	Austin	Texas	United States	78731
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.	Dallas	Texas	United States	75230
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.	San Antonio	Texas	United States	78237
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.	Norfolk	Virginia	United States	23510
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.	Renton	Washington	United States	98057
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.	Spokane	Washington	United States	99216
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.	Tacoma	Washington	United States	98405
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.	Wenatchee	Washington	United States	98801
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.	Menomonee Falls	Wisconsin	United States	53051
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.	Manatí		Puerto Rico	00674
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.	San Juan		Puerto Rico	00907
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.	Toa Baja		Puerto Rico	00949

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Lilly Clinical Trial Registry

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT00630825
• Other Study ID Numbers: 12068; H9X-MC-GBCJ
• First Posted: Mar 7, 2008
• Last Update Posted: Dec 10, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Dulaglutide

Study Results

Participant Flow

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Period Title: Overall Study
STARTED	65	65	66	66
Received at Least One Dose of Study Drug	65	65	66	66
COMPLETED	56	58	58	60
NOT COMPLETED	9	7	8	6

Baseline Characteristics

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo	Total
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks	Total of all reporting groups
Overall Participants	65	65	66	66	262
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.49 (11.28)	57.46 (11.72)	58.65 (11.69)	55.96 (12.49)	56.65 (11.84)
Sex: Female, Male (Count of Participants)
Female	31 47.7%	30 46.2%	31 47%	37 56.1%	129 49.2%
Male	34 52.3%	35 53.8%	35 53%	29 43.9%	133 50.8%
Race/Ethnicity, Customized (participants) [Number]
African	4 6.2%	6 9.2%	5 7.6%	4 6.1%	19 7.3%
Caucasian	36 55.4%	39 60%	40 60.6%	36 54.5%	151 57.6%
East Asian	1 1.5%	0 0%	0 0%	0 0%	1 0.4%
Hispanic	23 35.4%	20 30.8%	19 28.8%	26 39.4%	88 33.6%
Native American	1 1.5%	0 0%	2 3%	0 0%	3 1.1%
Region of Enrollment (participants) [Number]
United States	56 86.2%	56 86.2%	57 86.4%	58 87.9%	227 86.6%
Puerto Rico	9 13.8%	9 13.8%	9 13.6%	8 12.1%	35 13.4%
Glycosylated Hemoglobin (HbA1c) (percentage of glycosylated hemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	8.43 (0.99)	8.25 (0.99)	8.25 (0.89)	8.05 (0.82)	8.24 (0.93)
Body Mass Index (BMI) (kilograms per square meters (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms per square meters (kg/m^2)]	34.24 (4.11)	33.85 (3.95)	33.70 (4.11)	33.89 (4.31)	33.92 (4.10)
Body Weight (kilograms (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms (kg)]	98.60 (18.41)	96.68 (16.51)	94.76 (16.53)	94.74 (15.21)	96.18 (16.68)
Duration of Diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.63 (6.92)	8.13 (5.43)	8.97 (7.62)	7.48 (5.41)	8.30 (6.41)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Description	Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	62	63	65	65
Least Squares Mean (Standard Error) [percentage of glycosylated hemoglobin]	-1.52 (0.12)	-1.29 (0.12)	-1.28 (0.12)	-0.27 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Change From Baseline in Fasting Blood Glucose
Description	Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	51	52	48	53
Least Squares Mean (Standard Error) [millimoles per liter (mmol/L)]	-2.64 (0.33)	-2.04 (0.34)	-2.09 (0.34)	-0.49 (0.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)
Description	Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie [Kcal], 103 grams [g] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting [0]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.
Time Frame	Baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable glucose excursion data.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	52	56	54	59
Baseline (n=63, n=62, n=66, n=63)	11.03 (5.02)	11.12 (4.77)	10.32 (4.93)	10.76 (4.37)
Week 16 (n=52, n=56, n=54, n=59)	8.16 (4.58)	9.92 (5.32)	8.85 (4.94)	10.94 (4.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.047
	Comments	Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.025
	Comments	Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles
Description	Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
Time Frame	2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable blood glucose (SMBG) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	41	50	46	49
Week 4 (n=34, n=38, n=35, n=41)	-31.19 (5.85)	-35.94 (5.30)	-31.66 (5.36)	-8.10 (5.06)
Week 8 (n=34, n=41, n=38, n=41)	-43.00 (5.88)	-40.68 (5.43)	-36.02 (5.35)	-14.58 (5.38)
Week 16 (n=41, n=50, n=46, n=49)	-37.49 (5.89)	-41.79 (5.25)	-32.52 (5.40)	-8.67 (5.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)
Description	Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable HOMA2-%B or HOMA2-%S data.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	48	48	48	47
HOMA2-%B	45.61 (55.20)	44.26 (93.89)	39.20 (45.56)	1.04 (41.12)
HOMA2-%S	3.58 (18.51)	-1.65 (17.19)	0.46 (13.78)	2.46 (12.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.904
	Comments	Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.138
	Comments
	Method	ANCOVA
	Comments	Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.729
	Comments	Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%
Description	Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.
Time Frame	Baseline and 4 and 8 and 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	65	65	66	66
HbA1c levels <7.0%, Baseline	3.1 4.8%	4.6 7.1%	1.5 2.3%	4.5 6.8%
HbA1c levels ≤6.5%, Baseline	0.0 0%	1.5 2.3%	0.0 0%	0.0 0%
HbA1c levels <7.0%, Week 4	15.4 23.7%	30.8 47.4%	22.7 34.4%	7.6 11.5%
HbA1c levels ≤6.5%, Week 4	4.6 7.1%	7.7 11.8%	3.0 4.5%	1.5 2.3%
HbA1c levels <7%, Week 8	41.5 63.8%	47.7 73.4%	47.0 71.2%	15.2 23%
HbA1c levels ≤6.5%, Week 8	20.0 30.8%	26.2 40.3%	18.2 27.6%	1.5 2.3%
HbA1c levels <7%, Week 16	53.8 82.8%	50.8 78.2%	56.1 85%	15.2 23%
HbA1c levels ≤6.5%, Week 16	32.3 49.7%	32.3 49.7%	33.3 50.5%	4.5 6.8%

7. Secondary Outcome

Title	Change From Baseline in Body Weight
Description	LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
Time Frame	Baseline, 4, 8, and 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	63	63	65	65
4 weeks (n=63, n=63, n=65, n=65)	-1.28 (0.23)	-1.08 (0.23)	-0.50 (0.22)	-0.06 (0.22)
8 weeks (n=61, n=60, n=63, n=64)	-2.12 (0.31)	-1.67 (0.32)	-1.39 (0.31)	-0.12 (0.31)
16 weeks (n=63, n=63, n=65, n=65)	-2.51 (0.38)	-1.40 (0.38)	-1.58 (0.37)	-0.07 (0.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.113
	Comments	Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

8. Secondary Outcome

Title	Change From Baseline in Waist Circumference
Description	Mean change from baseline in waist circumference (a measure of central obesity).
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable waist circumference data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	59	60	63	60
Mean (Standard Deviation) [centimeters (cm)]	-1.92 (4.24)	-1.51 (4.56)	-1.33 (4.21)	0.20 (3.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1.0/2.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	1.0/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.028
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	0.5/1.0 Milligram (mg) LY2189265, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.047
	Comments	P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.
	Method	ANCOVA
	Comments

9. Secondary Outcome

Title	Nausea and Dyspepsia Measured by Visual Analog Scale
Description	Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.
Time Frame	One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable nausea or dyspepsia (abdominal pain and bloating) data.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	65	65	66	66
Nausea, Week before Baseline (n=52, 57, 61, 57)	4.81 (10.50)	3.56 (6.46)	3.70 (5.76)	3.35 (5.83)
Nausea, Week after Baseline (n=42, 46, 50, 50)	5.07 (8.58)	3.85 (6.46)	3.86 (5.96)	2.25 (4.82)
Ab pain, Week before Baseline (n=52, 57, 61, 57)	5.66 (11.37)	3.55 (9.14)	4.04 (7.15)	3.63 (6.58)
Ab pain, Week after Baseline (n=42, 46, 50, 50)	5.82 (9.41)	4.89 (13.35)	4.51 (8.60)	2.86 (7.27)
Bloating, Week before Baseline (n=52, 57, 61, 57)	11.49 (16.80)	8.11 (18.04)	10.21 (15.32)	9.30 (18.65)
Bloating, Week after Baseline (n=42, 46, 50, 50)	8.95 (12.90)	10.10 (16.64)	9.17 (15.61)	8.42 (20.05)
Nausea, Week before Week 4 (n=42, 55, 52, 59)	6.74 (10.89)	6.88 (11.47)	7.97 (15.33)	4.10 (7.32)
Nausea, Week after Week 4 (n=49, 58, 59, 54)	18.13 (24.52)	12.28 (19.46)	7.91 (12.39)	4.10 (7.57)
Ab pain, Week before Week 4 (n=42, 55, 52, 59)	6.28 (9.53)	7.74 (13.89)	6.38 (11.13)	4.45 (9.19)
Ab pain, Week after Week 4 (n=49, 58, 59, 54)	12.47 (20.44)	9.31 (15.77)	4.94 (8.89)	4.59 (7.88)
Bloating, Week before Week 4 (n=42, 55, 52, 59)	13.56 (19.51)	12.00 (19.17)	9.95 (13.27)	7.96 (15.77)
Bloating, Week after Week 4 (n=49, 58, 59, 54)	19.90 (25.61)	13.40 (21.15)	10.23 (13.88)	8.40 (14.96)
Nausea, Week before Week 8 (n=50, 51, 55, 58)	10.90 (20.26)	5.45 (10.63)	7.39 (13.53)	6.11 (12.59)
Nausea, Week after Week 8 (n=50, 54, 54, 55)	8.58 (12.88)	5.57 (11.50)	8.69 (13.41)	5.30 (11.52)
Ab pain, Week before Week 8 (n=50, 51, 55, 58)	10.76 (19.06)	5.76 (12.47)	5.12 (9.01)	6.65 (13.15)
Ab pain, Week after Week 8 (n=50, 54, 54, 55)	7.97 (14.72)	6.87 (14.56)	6.26 (11.93)	6.38 (12.74)
Bloating, Week before Week 8 (n=50, 51, 55, 58)	17.65 (26.41)	10.93 (17.92)	11.58 (20.13)	10.12 (19.20)
Bloating, Week after Week 8 (n=50, 54, 54, 55)	13.30 (18.66)	11.18 (19.56)	14.50 (20.95)	10.34 (17.17)
Nausea, Week before Week 16 (n=45, 49, 52, 54)	9.68 (17.79)	3.31 (5.53)	6.36 (10.82)	5.88 (14.41)
Nausea, Week after Week 16 (n=45, 48, 49, 53)	11.09 (17.62)	5.73 (10.80)	7.77 (12.25)	3.40 (6.40)
Ab pain, Week before Week 16 (n=45, 49, 52, 54)	6.46 (9.48)	5.68 (11.09)	6.26 (12.89)	6.17 (14.24)
Ab pain, Week after Week 16 (n=45, 48, 49, 53)	7.56 (14.28)	5.99 (11.53)	6.44 (12.58)	5.19 (11.72)
Bloating, Week before Week 16 (n=45, 49, 52, 54)	12.57 (18.93)	9.06 (16.78)	12.26 (20.06)	9.30 (18.60)
Bloating, Week after Week 16 (n=45, 48, 49, 53)	14.06 (20.46)	11.11 (19.62)	14.04 (22.26)	8.84 (17.44)

10. Secondary Outcome

Title	Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores
Description	Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.
Time Frame	Baseline and 4 and 8 and 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable Gastroparesis Cardinal Symptom Index (GCSI) questionnaire data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	65	65	66	66
Stomach fullness, Week 4 (n=62, n=60, n=65, n=65)	0.55 (1.51)	0.57 (1.35)	0.62 (1.26)	0.35 (1.39)
Stomach fullness, Week 8 (n=59, n=60, n=59, n=63)	0.46 (1.65)	0.30 (1.33)	0.71 (1.54)	0.25 (1.39)
Stomach fullness, Week 16 (n=63, n=62, n=65, n=65)	0.21 (1.58)	0.27 (1.28)	0.51 (1.34)	0.15 (1.34)
Bloating, Week 4 (n=62, n=60, n=65, n=65)	0.35 (0.10)	0.28 (0.93)	0.19 (0.91)	0.28 (0.84)
Bloating, Week 8 (n=59, n=60, n=60, n=63)	0.41 (1.34)	0.13 (1.02)	0.14 (1.32)	0.18 (0.92)
Bloating, Week 16 (n=63, n=62, n=65, n=65)	0.02 (1.04)	0.11 (0.94)	0.32 (1.32)	0.28 (0.86)
Nausea/Vomiting, Week 4 (n=62, n=60, n=64, n=65)	0.25 (0.71)	0.19 (0.71)	0.22 (0.52)	0.03 (0.40)
Nausea/Vomiting, Week 8 (n=59, n=60, n=60, n=63)	0.46 (0.97)	0.04 (0.64)	0.28 (0.62)	0.02 (0.39)
Nausea/Vomiting, Week 16 (n=63, n=62, n=65, n=65)	0.20 (0.64)	-0.01 (0.59)	0.27 (0.48)	-0.01 (0.36)

11. Secondary Outcome

Title	Number of Participants With a Hypoglycemic Event
Description	A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of <50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame	Baseline through 4, 8, and 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	65	65	66	66
Documented Hypoglycemic Event, Week 4	17 26.2%	17 26.2%	17 25.8%	9 13.6%
Documented Hypoglycemic Event, Week 8	11 16.9%	13 20%	15 22.7%	10 15.2%
Documented Hypoglycemic Event, Week 16	6 9.2%	10 15.4%	7 10.6%	8 12.1%
Severe Hypoglycemic Event, Week 4	0 0%	0 0%	0 0%	0 0%
Severe Hypoglycemic Event, Week 8	0 0%	0 0%	0 0%	0 0%
Severe Hypoglycemic Event, Week 16	0 0%	0 0%	0 0%	0 0%

12. Secondary Outcome

Title	Rate of Hypoglycemia Per 30 Days
Description	Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame	Baseline through 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	65	65	66	66
Mean (Standard Deviation) [events per participant per 30 days]	0.69 (1.29)	0.80 (1.60)	0.70 (1.18)	0.24 (0.54)

13. Secondary Outcome

Title	Change From Baseline in Lipids
Description	Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 or Placebo with evaluable lipid data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	65	65	66	66
Cholesterol (n=61, n=60, n=60, n=62)	-0.34	-0.05	-0.09	0.18
LDL-Cholesterol (n=61, n=60, n=60, n=61)	-0.26	-0.09	-0.07	0.10
HDL-Cholesterol (n=61, n=60, n=60, n=61)	-0.02	-0.02	0.00	0.00
Triglycerides (n=61, n=60, n=60, n=61)	-0.16	-0.02	-0.16	0.00

14. Secondary Outcome

Title	Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire
Description	The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6-point scale ranging from 1 "completely dissatisfied" to 6 "completely satisfied"; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 "all of the time" to 4 "none of the time"; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 "all of the time" to 4 "none of the time." These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized.
Time Frame	Baseline and 4 and 8 and 16 weeks

Outcome Measure Data

Analysis Population Description

Participants in the per-protocol population with evaluable PAM-D-S questionnaire data. The per-protocol population consisted of participants who received at least one dose of study medication, had no significant protocol violations, completed the double-blind treatment phase, and were compliant with the study drug.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	55	58	59	58
Baseline	72.7 111.8%	87.0 133.8%	87.5 132.6%	89.1 135%
Week 4	83.3 128.2%	90.2 138.8%	87.5 132.6%	87.0 131.8%
Week 8	82.9 127.5%	90.5 139.2%	90.9 137.7%	88.6 134.2%
Week 16	92.1 141.7%	90.2 138.8%	86.0 130.3%	93.0 140.9%

15. Secondary Outcome

Title	Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire
Description	This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.
Time Frame	Baseline and 4 and 8 and 16 weeks

Outcome Measure Data

Analysis Population Description

The items in the Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. Therefore, no participants were analyzed for validation purposes.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265	Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks	Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Measure Participants	0	0	0	0

16. Secondary Outcome

Title	Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)
Description	The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration).
Time Frame	Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265	1.0/1.0 Milligram (mg) LY2189265	0.5/1.0 Milligram (mg) LY2189265
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
Measure Participants	58	175	59
Mean (Standard Deviation) [nanograms*hour/milliliter (ng*h/mL)]	14587 (5674)	7876 (3064)	4488 (1746)

Adverse Events

Arm/Group Title	1.0/2.0 Milligram (mg) LY2189265		1.0/1.0 Milligram (mg) LY2189265		0.5/1.0 Milligram (mg) LY2189265		Placebo
Arm/Group Description	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks		LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks		LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks		Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
All Cause Mortality
	1.0/2.0 Milligram (mg) LY2189265		1.0/1.0 Milligram (mg) LY2189265		0.5/1.0 Milligram (mg) LY2189265		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	1.0/2.0 Milligram (mg) LY2189265		1.0/1.0 Milligram (mg) LY2189265		0.5/1.0 Milligram (mg) LY2189265		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/65 (1.5%)		2/65 (3.1%)		3/66 (4.5%)		1/66 (1.5%)
Gastrointestinal disorders
Pancreatitis	0/65 (0%)	0	0/65 (0%)	0	1/66 (1.5%)	1	0/66 (0%)	0
Infections and infestations
Pneumonia	1/65 (1.5%)	1	0/65 (0%)	0	0/66 (0%)	0	1/66 (1.5%)	1
Septic shock	0/65 (0%)	0	0/65 (0%)	0	0/66 (0%)	0	1/66 (1.5%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/65 (0%)	0	1/65 (1.5%)	2	0/66 (0%)	0	0/66 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/65 (0%)	0	1/65 (1.5%)	1	0/66 (0%)	0	0/66 (0%)	0
Psychiatric disorders
Hallucination	0/65 (0%)	0	0/65 (0%)	0	1/66 (1.5%)	1	0/66 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cryptogenic organising pneumonia	0/65 (0%)	0	0/65 (0%)	0	1/66 (1.5%)	1	0/66 (0%)	0
Other (Not Including Serious) Adverse Events
	1.0/2.0 Milligram (mg) LY2189265		1.0/1.0 Milligram (mg) LY2189265		0.5/1.0 Milligram (mg) LY2189265		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/65 (63.1%)		35/65 (53.8%)		40/66 (60.6%)		36/66 (54.5%)
Gastrointestinal disorders
Abdominal distension	9/65 (13.8%)	9	5/65 (7.7%)	5	3/66 (4.5%)	3	4/66 (6.1%)	4
Abdominal pain	4/65 (6.2%)	5	2/65 (3.1%)	2	5/66 (7.6%)	5	3/66 (4.5%)	4
Abdominal pain upper	4/65 (6.2%)	5	3/65 (4.6%)	3	2/66 (3%)	2	2/66 (3%)	2
Constipation	6/65 (9.2%)	6	3/65 (4.6%)	3	6/66 (9.1%)	6	0/66 (0%)	0
Diarrhoea	9/65 (13.8%)	10	4/65 (6.2%)	4	5/66 (7.6%)	5	5/66 (7.6%)	9
Nausea	9/65 (13.8%)	10	11/65 (16.9%)	11	9/66 (13.6%)	13	5/66 (7.6%)	5
Vomiting	7/65 (10.8%)	9	1/65 (1.5%)	1	3/66 (4.5%)	5	2/66 (3%)	2
General disorders
Chills	0/65 (0%)	0	0/65 (0%)	0	0/66 (0%)	0	3/66 (4.5%)	3
Early satiety	0/65 (0%)	0	3/65 (4.6%)	3	1/66 (1.5%)	1	0/66 (0%)	0
Infections and infestations
Influenza	0/65 (0%)	0	2/65 (3.1%)	2	3/66 (4.5%)	3	0/66 (0%)	0
Nasopharyngitis	5/65 (7.7%)	5	4/65 (6.2%)	4	2/66 (3%)	2	3/66 (4.5%)	3
Upper respiratory tract infection	0/65 (0%)	0	0/65 (0%)	0	1/66 (1.5%)	1	4/66 (6.1%)	4
Urinary tract infection	2/65 (3.1%)	2	1/65 (1.5%)	1	3/66 (4.5%)	3	0/66 (0%)	0
Musculoskeletal and connective tissue disorders
Muscle spasms	0/65 (0%)	0	1/65 (1.5%)	1	3/66 (4.5%)	3	2/66 (3%)	2
Nervous system disorders
Dizziness	3/65 (4.6%)	3	0/65 (0%)	0	3/66 (4.5%)	4	2/66 (3%)	2
Headache	1/65 (1.5%)	3	3/65 (4.6%)	5	1/66 (1.5%)	1	1/66 (1.5%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/65 (1.5%)	1	0/65 (0%)	0	2/66 (3%)	2	3/66 (4.5%)	3
Rhinitis seasonal	0/65 (0%)	0	0/65 (0%)	0	3/66 (4.5%)	3	0/66 (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.