Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

• Register: ClinicalTrials.gov
• Last refreshed on: 11 February 2013
• Main ID: NCT00039013
• Date of registration: 06/06/2002
• Primary sponsor: Amylin Pharmaceuticals, LLC.
• Public title: Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
• Scientific title: A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone
• Date of first enrolment: March 2002
• Target sample size: 336
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00039013
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with Type 2 diabetes mellitus

- Treated with metformin within a defined dose range for at least 3 months prior to
screening

- BMI= 27-45 kg/m2

- HbA1c value between 7.5% and 11%

Exclusion Criteria:

- Treated with oral anti-diabetic medications other than metformin within 3 months of
screening

- Patients treated previously with AC2993

- Patients presently treated with insulin



Age minimum: 16 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: AC2993

Drug: Placebo

Primary Outcome(s)

Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30) [Time Frame: Baseline (Day 1), Week 30]

Secondary Outcome(s)

Change in body weight from Baseline to each intermediate visit and Week 30 [Time Frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30]

Change in HbA1c from baseline (Day 1) to each of the intermediate visits [Time Frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24]

The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30 [Time Frame: Baseline (Day 1), and Week 30]

The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30 [Time Frame: Baseline (Day 1) and Week 30]

The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more [Time Frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30]

The time to achieve specific HbA1c target values of < 7% and < 8% [Time Frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30]

Secondary ID(s)

2993-112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors