A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.

Official Title
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A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Dulaglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic criteria) for at least 1 year. Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening). Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL) at screening. Have a screening body weight of ≥50 and ≤80 kilograms. Exclusion Criteria: Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor agonists. Have had a clinically significant cardiovascular disease. Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery. Have acute or chronic hepatitis, signs and symptoms of any other liver disease. Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis. Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter squared. In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dulaglutide, Placebo<br>Dulaglutide 0.75 mg administered subcutaneously (SC) once weekly for 4 weeks in period 1 followed by placebo administered SC once weekly for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2. | Drug: Dulaglutide<br>* Administered SC<br>* Other names: LY2189265;Drug: Placebo<br>* Administered SC<br>|
| Experimental: Placebo, Dulaglutide<br>Placebo administered SC once weekly for 4 weeks in Period 1 followed by Dulaglutide 0.75 mg administered SC for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2. | Drug: Dulaglutide<br>* Administered SC<br>* Other names: LY2189265;Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h]) | Least square (LS) means of glucose AUC 0-4h change from baseline was calculated using mixed-effects linear model. The model will include treatment, sequence, period, week, and treatment-by-week as fixed effects, baseline as a covariate, and participant as random effect. | Baseline, 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Blood Glucose | Change from baseline in fasting blood glucose obtained at pre-meal. | Baseline, 4 Weeks | 
| Change From Baseline in Postprandial Blood Glucose | Change from baseline in postprandial blood glucose at 120 minutes at week 4. | Baseline, 4 Weeks | 
| Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of the insulin change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | Baseline, 4 Weeks | 
| Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of C-peptide change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | Baseline, 4 Weeks | 
| Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of glucagon change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | Baseline, 4 Weeks | 
| Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of triglyceride change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | Baseline, 4 Weeks | 
| Number of Participants Who Develop Hypoglycemic Events | Number of participants who develop hypoglycemic events. | Baseline through 4 weeks |