Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.

Official Title
-----------------
Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy

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

Intervention / Treatment
-----------------
* Drug: exenatide
* Drug: exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes. Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD. HbA1c between 7.1% and 10.0%, inclusive. Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2 Exclusion Criteria: Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening. Have characteristics contraindicating metformin, SU, or TZD use. Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. Have used any prescription drug to promote weight loss within 3 months prior to screening. Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - exenatide before breakfast and dinner<br> | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)<br>* Other names: Byetta;|
| Active Comparator: 2 - exenatide before lunch and dinner<br> | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)<br>* Other names: Byetta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 | Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12 | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from Baseline to Week 12, and if measured, at each visit | Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8) | Baseline, Weeks 4, 8, 12 | 
| Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit | Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8) | Baseline, Weeks 4, 8, 12 | 
| Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12 | Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) | Baseline, Weeks 4, 8, 12 | 

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