A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will examine the response of several doses of LY2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in Japanese patients with type 2 diabetes.

Official Title
-----------------
A Dose Response Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: exenatide (LY2148568)
* Drug: exenatide (LY2148568)
* Drug: exenatide (LY2148568)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes. Have a body weight of >=50 kg. Exclusion Criteria: Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. Have participated in this study previously, or any other study using exenatide or other GLP-1 analogs. Are treated with any exogenous insulin within 3 months of screening. Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine). Have characteristics contraindicating for concomitant medication, according to product-specific label. Have severe allergy or hypersensitivity to any drug.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide 5 mcg/exenatide 10 mcg<br> | Drug: exenatide (LY2148568)<br>* subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks<br>* Other names: Byetta;|
| Experimental: Exenatide 5 mcg/exenatide 5 mcg<br> | Drug: exenatide (LY2148568)<br>* subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks<br>* Other names: Byetta;|
| Experimental: Exenatide 2.5 mcg/exenatide 2.5 mcg<br> | Drug: exenatide (LY2148568)<br>* subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks<br>* Other names: Byetta;|
| Placebo Comparator: Placebo/placebo<br> | Drug: Placebo<br>* subcutaneous injection twice daily, 0.02 mL to 0.04 mL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 | Assess dose response effect on glucose control as measured by HbA1c among four doses (2.5 μg, 5 μg, 10 μg, and placebo) of subcutaneous injection of exenatide, twice daily before meals in the morning and evening, for 12 weeks | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving HbA1c <7% at Week 12 | Total number of subjects achieving HbA1c <7% at Week 12 | 12 weeks | 
| Changes in fasting blood glucose from Visits 3 to 7 | Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7) | Baseline, Week 12 | 
| Change in Serum lipids from Baseline to Week 12 | Changes in serum lipids (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) from Baseline (Visit 3) to Week 12 (Visit 7) | Baseline, Week 12 | 
| Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12 | Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7) | Baseline, Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, exenatide, LY2148568, Lilly, Amylin, Japan