Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

Official Title
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A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Drug: Placebo 0.01 mL
* Drug: Placebo 0.02 mL
* Drug: Placebo 0.03 mL
* Drug: Placebo 0.04 mL
* Drug: AC2993 2.5 mcg
* Drug: AC2993 5.0 mcg
* Drug: AC2993 7.5 mcg
* Drug: AC2993 10.0 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with type 2 diabetes Treated with diet and exercise alone or with metformin for at least 3 months prior to screening BMI 27-45 kg/m^2 HbA1c between 7.0 % and 8.0 % Exclusion Criteria: Treated with other oral anti-diabetic agents other than metformin within 3 months of screening Patients previously treated with AC2993 Patients presently treated with insulin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Placebo 0.01 mL<br>2 week placebo lead-in followed by Placebo 0.01 mL | Drug: Placebo 0.01 mL<br>* 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily<br>|
| Placebo Comparator: Placebo 0.02 mL<br>2 week placebo lead-in followed by Placebo 0.02 mL | Drug: Placebo 0.02 mL<br>* 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily<br>|
| Placebo Comparator: Placebo 0.03 mL<br>2 week placebo lead-in followed by Placebo 0.03 mL | Drug: Placebo 0.03 mL<br>* 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily<br>|
| Placebo Comparator: Placebo 0.04 mL<br>2 week placebo lead-in followed by Placebo 0.04 mL | Drug: Placebo 0.04 mL<br>* 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily<br>|
| Experimental: AC2993 2.5 mcg<br>2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL | Drug: AC2993 2.5 mcg<br>* 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily<br>* Other names: synthetic exendin-4;|
| Experimental: AC2993 5.0 mcg<br>2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL | Drug: AC2993 5.0 mcg<br>* 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily<br>* Other names: synthetic exendin-4;|
| Experimental: AC2993 7.5 mcg<br>2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL | Drug: AC2993 7.5 mcg<br>* 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily<br>* Other names: synthetic exendin-4;|
| Experimental: AC2993 10.0 mcg<br>2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL | Drug: AC2993 10.0 mcg<br>* 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice 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 (Day 1) to study termination (Day 28) | Baseline (Day 1) to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from Baseline to Day 14 | Change in HbA1c from Baseline (Day 1) to Day 14 | Baseline, Day 14 | 
| Change in fasting plasma glucose from Baseline to Day 14 and to Day 28 | Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28) | Baseline, Day 14, Day28 | 
| Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28 | Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) | Baseline, Day 14, Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2