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EGO

CompletedPhase 2Results posted

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

The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

262

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 27-40•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00630825

Org study ID12068

Secondary IDH9X-MC-GBCJEli Lilly and Company

Timeline

Milestones

Study first posted2008-03-07estimated

Last update posted2014-12-10estimated

Results first posted2014-12-10estimated

Study start2008-04 (month precision)

Primary completion2009-01actual (month precision)

Study completion2009-01actual (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Patient-reported / QoL

Weight & body composition

Cardiometabolic biomarkers

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 4, 8, and 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
1.0/2.0 Milligram (mg) LY21892654 weeks (n=63, n=63, n=65, n=65)	-1.28	—
8 weeks (n=61, n=60, n=63, n=64)	-2.12	—
16 weeks (n=63, n=63, n=65, n=65)	-2.51	—
1.0/1.0 Milligram (mg) LY21892654 weeks (n=63, n=63, n=65, n=65)	-1.08	—
8 weeks (n=61, n=60, n=63, n=64)	-1.67	—
16 weeks (n=63, n=63, n=65, n=65)	-1.40	—
0.5/1.0 Milligram (mg) LY21892654 weeks (n=63, n=63, n=65, n=65)	-0.50	—
8 weeks (n=61, n=60, n=63, n=64)	-1.39	—
16 weeks (n=63, n=63, n=65, n=65)	-1.58	—
Placebo4 weeks (n=63, n=63, n=65, n=65)	-0.06	—
8 weeks (n=61, n=60, n=63, n=64)	-0.12	—
16 weeks (n=63, n=63, n=65, n=65)	-0.07	—

p<0.001ANCOVA

p0.113ANCOVA

p<0.001ANCOVA

p0.004ANCOVA

p0.001ANCOVA

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline, 16 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeters (cm)	95% CI
1.0/2.0 Milligram (mg) LY2189265	-1.92	—
1.0/1.0 Milligram (mg) LY2189265	-1.51	—
0.5/1.0 Milligram (mg) LY2189265	-1.33	—
Placebo	0.20	—

p0.009ANCOVA

p0.028ANCOVA

p0.047ANCOVA

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 4, 8, and 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, 16 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

12 endpoints

Primary/registry result

Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Time frame:Baseline, 16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated hemoglobin	95% CI
1.0/2.0 Milligram (mg) LY2189265	-1.52	—
1.0/1.0 Milligram (mg) LY2189265	-1.29	—
0.5/1.0 Milligram (mg) LY2189265	-1.28	—
Placebo	-0.27	—

p<0.001ANCOVA

Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Time frame:Baseline, 16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, 16 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), millimoles per liter (mmol/L)	95% CI
1.0/2.0 Milligram (mg) LY2189265	-2.64	—
1.0/1.0 Milligram (mg) LY2189265	-2.04	—
0.5/1.0 Milligram (mg) LY2189265	-2.09	—
Placebo	-0.49	—

p<0.001ANCOVA

Secondary/registry result

Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)

Time frame:Baseline and 16 weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), millimoles per liter (mmol/L)*minute	95% CI
1.0/2.0 Milligram (mg) LY2189265Baseline (n=63, n=62, n=66, n=63)	11.03	—
Week 16 (n=52, n=56, n=54, n=59)	8.16	—
1.0/1.0 Milligram (mg) LY2189265Baseline (n=63, n=62, n=66, n=63)	11.12	—
Week 16 (n=52, n=56, n=54, n=59)	9.92	—
0.5/1.0 Milligram (mg) LY2189265Baseline (n=63, n=62, n=66, n=63)	10.32	—
Week 16 (n=52, n=56, n=54, n=59)	8.85	—
PlaceboBaseline (n=63, n=62, n=66, n=63)	10.76	—
Week 16 (n=52, n=56, n=54, n=59)	10.94	—

p<0.001ANCOVA

p0.047ANCOVA

p0.025ANCOVA

Secondary/registry result

Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles

Time frame:2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
1.0/2.0 Milligram (mg) LY2189265Week 4 (n=34, n=38, n=35, n=41)	-31.19	—
Week 8 (n=34, n=41, n=38, n=41)	-43.00	—
Week 16 (n=41, n=50, n=46, n=49)	-37.49	—
1.0/1.0 Milligram (mg) LY2189265Week 4 (n=34, n=38, n=35, n=41)	-35.94	—
Week 8 (n=34, n=41, n=38, n=41)	-40.68	—
Week 16 (n=41, n=50, n=46, n=49)	-41.79	—
0.5/1.0 Milligram (mg) LY2189265Week 4 (n=34, n=38, n=35, n=41)	-31.66	—
Week 8 (n=34, n=41, n=38, n=41)	-36.02	—
Week 16 (n=41, n=50, n=46, n=49)	-32.52	—
PlaceboWeek 4 (n=34, n=38, n=35, n=41)	-8.10	—
Week 8 (n=34, n=41, n=38, n=41)	-14.58	—
Week 16 (n=41, n=50, n=46, n=49)	-8.67	—

p<0.001ANCOVA

Secondary/registry result

Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)

Time frame:Baseline, 16 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), percentage of HOMA2	95% CI
1.0/2.0 Milligram (mg) LY2189265HOMA2-%B	45.61	—
HOMA2-%S	3.58	—
1.0/1.0 Milligram (mg) LY2189265HOMA2-%B	44.26	—
HOMA2-%S	-1.65	—
0.5/1.0 Milligram (mg) LY2189265HOMA2-%B	39.20	—
HOMA2-%S	0.46	—
PlaceboHOMA2-%B	1.04	—
HOMA2-%S	2.46	—

p<0.001ANCOVA

p0.004ANCOVA

p0.904ANCOVA

p0.138ANCOVA

p0.729ANCOVA

Secondary/registry result

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%

Time frame:Baseline and 4 and 8 and 16 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.0/2.0 Milligram (mg) LY2189265HbA1c levels <7.0%, Baseline	3.1	—
HbA1c levels ≤6.5%, Baseline	0.0	—
HbA1c levels <7.0%, Week 4	15.4	—
HbA1c levels ≤6.5%, Week 4	4.6	—
HbA1c levels <7%, Week 8	41.5	—
HbA1c levels ≤6.5%, Week 8	20.0	—
HbA1c levels <7%, Week 16	53.8	—
HbA1c levels ≤6.5%, Week 16	32.3	—
1.0/1.0 Milligram (mg) LY2189265HbA1c levels <7.0%, Baseline	4.6	—
HbA1c levels ≤6.5%, Baseline	1.5	—
HbA1c levels <7.0%, Week 4	30.8	—
HbA1c levels ≤6.5%, Week 4	7.7	—
HbA1c levels <7%, Week 8	47.7	—
HbA1c levels ≤6.5%, Week 8	26.2	—
HbA1c levels <7%, Week 16	50.8	—
HbA1c levels ≤6.5%, Week 16	32.3	—
0.5/1.0 Milligram (mg) LY2189265HbA1c levels <7.0%, Baseline	1.5	—
HbA1c levels ≤6.5%, Baseline	0.0	—
HbA1c levels <7.0%, Week 4	22.7	—
HbA1c levels ≤6.5%, Week 4	3.0	—
HbA1c levels <7%, Week 8	47.0	—
HbA1c levels ≤6.5%, Week 8	18.2	—
HbA1c levels <7%, Week 16	56.1	—
HbA1c levels ≤6.5%, Week 16	33.3	—
PlaceboHbA1c levels <7.0%, Baseline	4.5	—
HbA1c levels ≤6.5%, Baseline	0.0	—
HbA1c levels <7.0%, Week 4	7.6	—
HbA1c levels ≤6.5%, Week 4	1.5	—
HbA1c levels <7%, Week 8	15.2	—
HbA1c levels ≤6.5%, Week 8	1.5	—
HbA1c levels <7%, Week 16	15.2	—
HbA1c levels ≤6.5%, Week 16	4.5	—

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, 16 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)

Time frame:Baseline and 16 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles

Time frame:2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)

Time frame:Baseline, 16 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%

Time frame:Baseline and 4 and 8 and 16 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/registry result

Change From Baseline in Lipids

Time frame:Baseline, 16 weeks

change from baseline, improvement

componentsTotal cholesterol, change, LDL-C, change, HDL-C, change, Triglycerides, change

Posted result

Group	Value (median), millimoles per liter (mmol/L)	95% CI
1.0/2.0 Milligram (mg) LY2189265Cholesterol (n=61, n=60, n=60, n=62)	-0.34	-3.44 – 2.28
LDL-Cholesterol (n=61, n=60, n=60, n=61)	-0.26	-2.80 – 2.23
HDL-Cholesterol (n=61, n=60, n=60, n=61)	-0.02	-0.33 – 0.41
Triglycerides (n=61, n=60, n=60, n=61)	-0.16	-7.63 – 2.22
1.0/1.0 Milligram (mg) LY2189265Cholesterol (n=61, n=60, n=60, n=62)	-0.05	-1.37 – 2.69
LDL-Cholesterol (n=61, n=60, n=60, n=61)	-0.09	-1.22 – 1.58
HDL-Cholesterol (n=61, n=60, n=60, n=61)	-0.02	-0.37 – 0.54
Triglycerides (n=61, n=60, n=60, n=61)	-0.02	-4.84 – 2.96
0.5/1.0 Milligram (mg) LY2189265Cholesterol (n=61, n=60, n=60, n=62)	-0.09	-2.18 – 4.77
LDL-Cholesterol (n=61, n=60, n=60, n=61)	-0.07	-1.39 – 4.27
HDL-Cholesterol (n=61, n=60, n=60, n=61)	0.00	-0.26 – 0.23
Triglycerides (n=61, n=60, n=60, n=61)	-0.16	-4.25 – 2.96
PlaceboCholesterol (n=61, n=60, n=60, n=62)	0.18	-1.91 – 2.56
LDL-Cholesterol (n=61, n=60, n=60, n=61)	0.10	-0.83 – 2.12
HDL-Cholesterol (n=61, n=60, n=60, n=61)	0.00	-0.24 – 0.26
Triglycerides (n=61, n=60, n=60, n=61)	0.00	-7.39 – 5.69

Secondary/protocol endpoint

Change From Baseline in Lipids

Time frame:Baseline, 16 weeks

change from baseline, improvement

Patient-reported / QoL

5 endpoints

Secondary/registry result

Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores

Time frame:Baseline and 4 and 8 and 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
1.0/2.0 Milligram (mg) LY2189265Stomach fullness, Week 4 (n=62, n=60, n=65, n=65)	0.55	—
Stomach fullness, Week 8 (n=59, n=60, n=59, n=63)	0.46	—
Stomach fullness, Week 16 (n=63, n=62, n=65, n=65)	0.21	—
Bloating, Week 4 (n=62, n=60, n=65, n=65)	0.35	—
Bloating, Week 8 (n=59, n=60, n=60, n=63)	0.41	—
Bloating, Week 16 (n=63, n=62, n=65, n=65)	0.02	—
Nausea/Vomiting, Week 4 (n=62, n=60, n=64, n=65)	0.25	—
Nausea/Vomiting, Week 8 (n=59, n=60, n=60, n=63)	0.46	—
Nausea/Vomiting, Week 16 (n=63, n=62, n=65, n=65)	0.20	—
1.0/1.0 Milligram (mg) LY2189265Stomach fullness, Week 4 (n=62, n=60, n=65, n=65)	0.57	—
Stomach fullness, Week 8 (n=59, n=60, n=59, n=63)	0.30	—
Stomach fullness, Week 16 (n=63, n=62, n=65, n=65)	0.27	—
Bloating, Week 4 (n=62, n=60, n=65, n=65)	0.28	—
Bloating, Week 8 (n=59, n=60, n=60, n=63)	0.13	—
Bloating, Week 16 (n=63, n=62, n=65, n=65)	0.11	—
Nausea/Vomiting, Week 4 (n=62, n=60, n=64, n=65)	0.19	—
Nausea/Vomiting, Week 8 (n=59, n=60, n=60, n=63)	0.04	—
Nausea/Vomiting, Week 16 (n=63, n=62, n=65, n=65)	-0.01	—
0.5/1.0 Milligram (mg) LY2189265Stomach fullness, Week 4 (n=62, n=60, n=65, n=65)	0.62	—
Stomach fullness, Week 8 (n=59, n=60, n=59, n=63)	0.71	—
Stomach fullness, Week 16 (n=63, n=62, n=65, n=65)	0.51	—
Bloating, Week 4 (n=62, n=60, n=65, n=65)	0.19	—
Bloating, Week 8 (n=59, n=60, n=60, n=63)	0.14	—
Bloating, Week 16 (n=63, n=62, n=65, n=65)	0.32	—
Nausea/Vomiting, Week 4 (n=62, n=60, n=64, n=65)	0.22	—
Nausea/Vomiting, Week 8 (n=59, n=60, n=60, n=63)	0.28	—
Nausea/Vomiting, Week 16 (n=63, n=62, n=65, n=65)	0.27	—
PlaceboStomach fullness, Week 4 (n=62, n=60, n=65, n=65)	0.35	—
Stomach fullness, Week 8 (n=59, n=60, n=59, n=63)	0.25	—
Stomach fullness, Week 16 (n=63, n=62, n=65, n=65)	0.15	—
Bloating, Week 4 (n=62, n=60, n=65, n=65)	0.28	—
Bloating, Week 8 (n=59, n=60, n=60, n=63)	0.18	—
Bloating, Week 16 (n=63, n=62, n=65, n=65)	0.28	—
Nausea/Vomiting, Week 4 (n=62, n=60, n=64, n=65)	0.03	—
Nausea/Vomiting, Week 8 (n=59, n=60, n=60, n=63)	0.02	—
Nausea/Vomiting, Week 16 (n=63, n=62, n=65, n=65)	-0.01	—

Secondary/registry result

Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire

Time frame:Baseline and 4 and 8 and 16 weeks

descriptive

Posted result

Group	Value (number), percentage of participants	95% CI
1.0/2.0 Milligram (mg) LY2189265Baseline	72.7	—
Week 4	83.3	—
Week 8	82.9	—
Week 16	92.1	—
1.0/1.0 Milligram (mg) LY2189265Baseline	87.0	—
Week 4	90.2	—
Week 8	90.5	—
Week 16	90.2	—
0.5/1.0 Milligram (mg) LY2189265Baseline	87.5	—
Week 4	87.5	—
Week 8	90.9	—
Week 16	86.0	—
PlaceboBaseline	89.1	—
Week 4	87.0	—
Week 8	88.6	—
Week 16	93.0	—

Secondary/protocol endpoint

Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores

Time frame:Baseline and 4 and 8 and 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire

Time frame:Baseline and 4 and 8 and 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire

Time frame:Baseline and 4 and 8 and 16 weeks

descriptive

Safety / tolerability / PK

8 endpoints

Secondary/registry result

Nausea and Dyspepsia Measured by Visual Analog Scale

Time frame:One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits

descriptive

Posted result

Group	Value (mean), units on a scale	95% CI
1.0/2.0 Milligram (mg) LY2189265Nausea, Week before Baseline (n=52, 57, 61, 57)	4.81	—
Nausea, Week after Baseline (n=42, 46, 50, 50)	5.07	—
Ab pain, Week before Baseline (n=52, 57, 61, 57)	5.66	—
Ab pain, Week after Baseline (n=42, 46, 50, 50)	5.82	—
Bloating, Week before Baseline (n=52, 57, 61, 57)	11.49	—
Bloating, Week after Baseline (n=42, 46, 50, 50)	8.95	—
Nausea, Week before Week 4 (n=42, 55, 52, 59)	6.74	—
Nausea, Week after Week 4 (n=49, 58, 59, 54)	18.13	—
Ab pain, Week before Week 4 (n=42, 55, 52, 59)	6.28	—
Ab pain, Week after Week 4 (n=49, 58, 59, 54)	12.47	—
Bloating, Week before Week 4 (n=42, 55, 52, 59)	13.56	—
Bloating, Week after Week 4 (n=49, 58, 59, 54)	19.90	—
Nausea, Week before Week 8 (n=50, 51, 55, 58)	10.90	—
Nausea, Week after Week 8 (n=50, 54, 54, 55)	8.58	—
Ab pain, Week before Week 8 (n=50, 51, 55, 58)	10.76	—
Ab pain, Week after Week 8 (n=50, 54, 54, 55)	7.97	—
Bloating, Week before Week 8 (n=50, 51, 55, 58)	17.65	—
Bloating, Week after Week 8 (n=50, 54, 54, 55)	13.30	—
Nausea, Week before Week 16 (n=45, 49, 52, 54)	9.68	—
Nausea, Week after Week 16 (n=45, 48, 49, 53)	11.09	—
Ab pain, Week before Week 16 (n=45, 49, 52, 54)	6.46	—
Ab pain, Week after Week 16 (n=45, 48, 49, 53)	7.56	—
Bloating, Week before Week 16 (n=45, 49, 52, 54)	12.57	—
Bloating, Week after Week 16 (n=45, 48, 49, 53)	14.06	—
1.0/1.0 Milligram (mg) LY2189265Nausea, Week before Baseline (n=52, 57, 61, 57)	3.56	—
Nausea, Week after Baseline (n=42, 46, 50, 50)	3.85	—
Ab pain, Week before Baseline (n=52, 57, 61, 57)	3.55	—
Ab pain, Week after Baseline (n=42, 46, 50, 50)	4.89	—
Bloating, Week before Baseline (n=52, 57, 61, 57)	8.11	—
Bloating, Week after Baseline (n=42, 46, 50, 50)	10.10	—
Nausea, Week before Week 4 (n=42, 55, 52, 59)	6.88	—
Nausea, Week after Week 4 (n=49, 58, 59, 54)	12.28	—
Ab pain, Week before Week 4 (n=42, 55, 52, 59)	7.74	—
Ab pain, Week after Week 4 (n=49, 58, 59, 54)	9.31	—
Bloating, Week before Week 4 (n=42, 55, 52, 59)	12.00	—
Bloating, Week after Week 4 (n=49, 58, 59, 54)	13.40	—
Nausea, Week before Week 8 (n=50, 51, 55, 58)	5.45	—
Nausea, Week after Week 8 (n=50, 54, 54, 55)	5.57	—
Ab pain, Week before Week 8 (n=50, 51, 55, 58)	5.76	—
Ab pain, Week after Week 8 (n=50, 54, 54, 55)	6.87	—
Bloating, Week before Week 8 (n=50, 51, 55, 58)	10.93	—
Bloating, Week after Week 8 (n=50, 54, 54, 55)	11.18	—
Nausea, Week before Week 16 (n=45, 49, 52, 54)	3.31	—
Nausea, Week after Week 16 (n=45, 48, 49, 53)	5.73	—
Ab pain, Week before Week 16 (n=45, 49, 52, 54)	5.68	—
Ab pain, Week after Week 16 (n=45, 48, 49, 53)	5.99	—
Bloating, Week before Week 16 (n=45, 49, 52, 54)	9.06	—
Bloating, Week after Week 16 (n=45, 48, 49, 53)	11.11	—
0.5/1.0 Milligram (mg) LY2189265Nausea, Week before Baseline (n=52, 57, 61, 57)	3.70	—
Nausea, Week after Baseline (n=42, 46, 50, 50)	3.86	—
Ab pain, Week before Baseline (n=52, 57, 61, 57)	4.04	—
Ab pain, Week after Baseline (n=42, 46, 50, 50)	4.51	—
Bloating, Week before Baseline (n=52, 57, 61, 57)	10.21	—
Bloating, Week after Baseline (n=42, 46, 50, 50)	9.17	—
Nausea, Week before Week 4 (n=42, 55, 52, 59)	7.97	—
Nausea, Week after Week 4 (n=49, 58, 59, 54)	7.91	—
Ab pain, Week before Week 4 (n=42, 55, 52, 59)	6.38	—
Ab pain, Week after Week 4 (n=49, 58, 59, 54)	4.94	—
Bloating, Week before Week 4 (n=42, 55, 52, 59)	9.95	—
Bloating, Week after Week 4 (n=49, 58, 59, 54)	10.23	—
Nausea, Week before Week 8 (n=50, 51, 55, 58)	7.39	—
Nausea, Week after Week 8 (n=50, 54, 54, 55)	8.69	—
Ab pain, Week before Week 8 (n=50, 51, 55, 58)	5.12	—
Ab pain, Week after Week 8 (n=50, 54, 54, 55)	6.26	—
Bloating, Week before Week 8 (n=50, 51, 55, 58)	11.58	—
Bloating, Week after Week 8 (n=50, 54, 54, 55)	14.50	—
Nausea, Week before Week 16 (n=45, 49, 52, 54)	6.36	—
Nausea, Week after Week 16 (n=45, 48, 49, 53)	7.77	—
Ab pain, Week before Week 16 (n=45, 49, 52, 54)	6.26	—
Ab pain, Week after Week 16 (n=45, 48, 49, 53)	6.44	—
Bloating, Week before Week 16 (n=45, 49, 52, 54)	12.26	—
Bloating, Week after Week 16 (n=45, 48, 49, 53)	14.04	—
PlaceboNausea, Week before Baseline (n=52, 57, 61, 57)	3.35	—
Nausea, Week after Baseline (n=42, 46, 50, 50)	2.25	—
Ab pain, Week before Baseline (n=52, 57, 61, 57)	3.63	—
Ab pain, Week after Baseline (n=42, 46, 50, 50)	2.86	—
Bloating, Week before Baseline (n=52, 57, 61, 57)	9.30	—
Bloating, Week after Baseline (n=42, 46, 50, 50)	8.42	—
Nausea, Week before Week 4 (n=42, 55, 52, 59)	4.10	—
Nausea, Week after Week 4 (n=49, 58, 59, 54)	4.10	—
Ab pain, Week before Week 4 (n=42, 55, 52, 59)	4.45	—
Ab pain, Week after Week 4 (n=49, 58, 59, 54)	4.59	—
Bloating, Week before Week 4 (n=42, 55, 52, 59)	7.96	—
Bloating, Week after Week 4 (n=49, 58, 59, 54)	8.40	—
Nausea, Week before Week 8 (n=50, 51, 55, 58)	6.11	—
Nausea, Week after Week 8 (n=50, 54, 54, 55)	5.30	—
Ab pain, Week before Week 8 (n=50, 51, 55, 58)	6.65	—
Ab pain, Week after Week 8 (n=50, 54, 54, 55)	6.38	—
Bloating, Week before Week 8 (n=50, 51, 55, 58)	10.12	—
Bloating, Week after Week 8 (n=50, 54, 54, 55)	10.34	—
Nausea, Week before Week 16 (n=45, 49, 52, 54)	5.88	—
Nausea, Week after Week 16 (n=45, 48, 49, 53)	3.40	—
Ab pain, Week before Week 16 (n=45, 49, 52, 54)	6.17	—
Ab pain, Week after Week 16 (n=45, 48, 49, 53)	5.19	—
Bloating, Week before Week 16 (n=45, 49, 52, 54)	9.30	—
Bloating, Week after Week 16 (n=45, 48, 49, 53)	8.84	—

Secondary/registry result

Number of Participants With a Hypoglycemic Event

Time frame:Baseline through 4, 8, and 16 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), participants	95% CI
1.0/2.0 Milligram (mg) LY2189265Documented Hypoglycemic Event, Week 4	17	—
Documented Hypoglycemic Event, Week 8	11	—
Documented Hypoglycemic Event, Week 16	6	—
Severe Hypoglycemic Event, Week 4	0	—
Severe Hypoglycemic Event, Week 8	0	—
Severe Hypoglycemic Event, Week 16	0	—
1.0/1.0 Milligram (mg) LY2189265Documented Hypoglycemic Event, Week 4	17	—
Documented Hypoglycemic Event, Week 8	13	—
Documented Hypoglycemic Event, Week 16	10	—
Severe Hypoglycemic Event, Week 4	0	—
Severe Hypoglycemic Event, Week 8	0	—
Severe Hypoglycemic Event, Week 16	0	—
0.5/1.0 Milligram (mg) LY2189265Documented Hypoglycemic Event, Week 4	17	—
Documented Hypoglycemic Event, Week 8	15	—
Documented Hypoglycemic Event, Week 16	7	—
Severe Hypoglycemic Event, Week 4	0	—
Severe Hypoglycemic Event, Week 8	0	—
Severe Hypoglycemic Event, Week 16	0	—
PlaceboDocumented Hypoglycemic Event, Week 4	9	—
Documented Hypoglycemic Event, Week 8	10	—
Documented Hypoglycemic Event, Week 16	8	—
Severe Hypoglycemic Event, Week 4	0	—
Severe Hypoglycemic Event, Week 8	0	—
Severe Hypoglycemic Event, Week 16	0	—

Secondary/registry result

Rate of Hypoglycemia Per 30 Days

Time frame:Baseline through 16 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per participant per 30 days	95% CI
1.0/2.0 Milligram (mg) LY2189265	0.69	—
1.0/1.0 Milligram (mg) LY2189265	0.80	—
0.5/1.0 Milligram (mg) LY2189265	0.70	—
Placebo	0.24	—

Secondary/registry result

Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)

Time frame:Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanogramshour/milliliter (ngh/mL)	95% CI
1.0/2.0 Milligram (mg) LY2189265	14587	—
1.0/1.0 Milligram (mg) LY2189265	7876	—
0.5/1.0 Milligram (mg) LY2189265	4488	—

Secondary/protocol endpoint

Nausea and Dyspepsia Measured by Visual Analog Scale

Time frame:One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits

descriptive

Secondary/protocol endpoint

Number of Participants With a Hypoglycemic Event

Time frame:Baseline through 4, 8, and 16 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Rate of Hypoglycemia Per 30 Days

Time frame:Baseline through 16 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)

Time frame:Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks

AUC₀–∞

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/registry result

Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire

Time frame:Baseline and 4 and 8 and 16 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.