Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.

Official Title
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A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Placebo 0.04 mL twice daily
* Drug: Placebo 0.04 mL once daily
* Drug: Placebo 0.08 mL once daily
* Drug: B - Exenatide 10 mcg twice daily
* Drug: C - Exenatide 10 mcg once daily
* Drug: Exenatide 20 mcg once daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years. Exclusion Criteria: Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease. Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A1 - Placebo 0.04 mL twice daily<br> | Drug: Placebo 0.04 mL twice daily<br>* Subcutaneously injected, 0.04 mL, twice daily<br>|
| Placebo Comparator: A2 - Placebo 0.04 mL once daily<br> | Drug: Placebo 0.04 mL once daily<br>* Subcutaneously injected, 0.04 mL, once daily<br>|
| Placebo Comparator: A3 - Placebo 0.08 mL once daily<br> | Drug: Placebo 0.08 mL once daily<br>* Subcutaneously injected, 0.08 mL, once daily<br>|
| Experimental: B - Exenatide 10 mcg twice daily<br> | Drug: B - Exenatide 10 mcg twice daily<br>* Subcutaneously injected, 10 mcg (0.04 mL), twice daily<br>* Other names: synthetic exendin-4;|
| Experimental: C - Exenatide 10 mcg once daily<br> | Drug: C - Exenatide 10 mcg once daily<br>* Subcutaneously injected, 10 mcg (0.04 mL), once daily<br>* Other names: synthetic exendin-4;|
| Experimental: D - Exenatide 20 mcg once daily<br> | Drug: Exenatide 20 mcg once daily<br>* Subcutaneously injected, 20 mcg (0.08 mL), once daily<br>* Other names: synthetic exendin-4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 | Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28) | Baseline, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28 | Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) | Baseline, Day 14, Day 28 | 
| Change in body weight from Baseline to Day 14 and to Day 28 | Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) | Baseline, Day 14, Day28 | 
| Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28 | Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) | Baseline, Day 14, Day 28 | 
| Change in postprandial blood glucose concentrations from Baseline to Day 28 | Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28) | Baseline, Week 28 | 

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