Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
- Registration Number
- NCT00039013
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (metformin) throughout the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
- 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%
- Treated with oral anti-diabetic medications other than metformin within 3 months of screening
- Patients treated previously with AC2993
- Patients presently treated with insulin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AC2993 5 mcg (0.02 mL) AC2993 Placebo, then AC2993 5 mcg, then AC2993 5 mcg Placebo 0.02 mL Placebo Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL AC2993 10mcg (0.04 mL) AC2993 Placebo, then AC2993 5 mcg, then AC2993 10 mcg Placebo 0.04 mL Placebo Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30) Baseline (Day 1), Week 30 Change in HbA1c from from baseline, measured from Visit 3 (Day 1) to study termination (Week 30).
- Secondary Outcome Measures
Name Time Method Change in HbA1c from baseline (Day 1) to each of the intermediate visits Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24 Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, and Week 24)
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30 Baseline (Day 1) and Week 30 The number of subjects achieving HbA1c target values of \< 7% and \< 8% by study termination (Week 30)
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30 Baseline (Day 1), and Week 30 The number of subjects achieving HbA1c reductions of \> 0.5% and \> 1.0% by study termination (Week 30)
The time to achieve specific HbA1c target values of < 7% and < 8% Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30 The time it takes subjects to achieve HbA1c target values of \< 7% and \< 8%
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30 The time it takes subjects to achieve HbA1c reductions of 0.5% or more and \>1.0% or more
Change in body weight from Baseline to each intermediate visit and Week 30 Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30 Change in body weight (kg) from Baseline to each intermediate visit and Week 30
Trial Locations
- Locations (127)
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Eclectic Family Care
🇺🇸Eclectic, Alabama, United States
Winston Physician Services
🇺🇸Haleyville, Alabama, United States
Simon Williamson Clinic
🇺🇸Hueytown, Alabama, United States
Extended Arm Physicians/ Southern Drug
🇺🇸Montgomery, Alabama, United States
Southern Drug Research Network
🇺🇸Tallassee, Alabama, United States
Clinic of Physicians and Surgeons, Ltd.
🇺🇸Mesa, Arizona, United States
ANA Ventures, LLC
🇺🇸Mesa, Arizona, United States
Scroll for more (117 remaining)Pinnacle Research Group🇺🇸Anniston, Alabama, United States