Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Interventions
- Drug: AC2993 7.5 mcgDrug: Placebo 0.03 mLDrug: Placebo 0.01 mLDrug: Placebo 0.04 mLDrug: AC2993 2.5 mcgDrug: Placebo 0.02 mLDrug: AC2993 10.0 mcgDrug: AC2993 5.0 mcg
- Registration Number
- NCT00044694
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- 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 %
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AC2993 7.5 mcg AC2993 7.5 mcg 2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL Placebo 0.03 mL Placebo 0.03 mL 2 week placebo lead-in followed by Placebo 0.03 mL Placebo 0.01 mL Placebo 0.01 mL 2 week placebo lead-in followed by Placebo 0.01 mL Placebo 0.04 mL Placebo 0.04 mL 2 week placebo lead-in followed by Placebo 0.04 mL AC2993 2.5 mcg AC2993 2.5 mcg 2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL Placebo 0.02 mL Placebo 0.02 mL 2 week placebo lead-in followed by Placebo 0.02 mL AC2993 10.0 mcg AC2993 10.0 mcg 2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL AC2993 5.0 mcg AC2993 5.0 mcg 2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 Baseline (Day 1) to Day 28 Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
- Secondary Outcome Measures
Name Time Method Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28 Baseline, Day 14, Day 28 Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Change in HbA1c from Baseline to Day 14 Baseline, Day 14 Change in HbA1c from Baseline (Day 1) to Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28 Baseline, Day 14, Day28 Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)
Related Research Topics
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Trial Locations
- Locations (32)
Innovative Clinical Trials
🇺🇸Birmingham, Alabama, United States
Healthsouth Clinical Research
🇺🇸Desoto, Texas, United States
Endocrinology Clinic of O.C.
🇺🇸Anaheim, California, United States
Pioneer Medical Group
🇺🇸Bellflower, California, United States
International Clinical Research Network
🇺🇸Chula Vista, California, United States
Bautista Research and Medical Clinic
🇺🇸Fresno, California, United States
Whittier Institute for Diabetes
🇺🇸La Jolla, California, United States
Richard Cherlin, M.D.
🇺🇸Los Gatos, California, United States
Dr. Martinez Medical Clinic
🇺🇸Moreno Valley, California, United States
Anshutz Outpatient Pavilion
🇺🇸Aurora, Colorado, United States
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