Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Placebo plus metformin IR
- Registration Number
- NCT00885378
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- Type 2 diabetes
- 18-78 years of age
- Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
- A1C: 7-10%
- C-peptide: ≥ 0.8 ng/mL
- Body mass index (BMI): ≤45 kg/m^2
- Women of childbearing potential unable or unwilling to use acceptable birth control
- Women who are pregnant or breastfeeding
- Fasting plasma glucose (FPG) >270 mg/dL
- Significant cardiovascular history
- Symptoms of poorly controlled diabetes
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Insulin therapy within one year of screening
- Cardiovascular even within the prior 6 months
- New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction <=40%
- Significant history of renal or hepatic disease
- History of a psychiatric disorder, alcohol or drug abuse within the previous year
- Treatment with potent CYP3A4 inhibitors or inducers
- Immunocompromised participants
- Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saxagliptin plus metformin IR Saxagliptin plus metformin IR - Placebo plus metformin IR Placebo plus metformin IR -
- Primary Outcome Measures
Name Time Method Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 Baseline, Week 12 Mean change was adjusted for baseline.
- Secondary Outcome Measures
Name Time Method Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) Baseline, Week 12 Mean change was adjusted for baseline.
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12 Week 12 Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12 Week 12 Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Trial Locations
- Locations (26)
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Wells Institute For Health Awareness
🇺🇸Kettering, Ohio, United States
Newark Physician Associates
🇺🇸Newark, Ohio, United States
Southland Clinical Research Center, Inc.
🇺🇸Fountain Valley, California, United States
Ritchken & First M.D.'S
🇺🇸San Diego, California, United States
Community Health Care Of Manchester
🇺🇸Akron, Ohio, United States
Jolene K. Berg, Md., Dgd Research, Inc.
🇺🇸San Antonio, Texas, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Southeastern Research Associates, Inc
🇺🇸Taylors, South Carolina, United States
Central Florida Clinical Trials, Inc.
🇺🇸Altamonte Springs, Florida, United States
Family Care Associates Of Nw Florida
🇺🇸Chipley, Florida, United States
Nextphase Clinical Trials, Inc.
🇺🇸Miami, Florida, United States
Middle Georgia Drug Study Center, Llc
🇺🇸Perry, Georgia, United States
Louisiana Heart Center Research
🇺🇸Slidell, Louisiana, United States
Jackson Clinic
🇺🇸Rolling Fork, Mississippi, United States
Midwest Regional Research, Inc.
🇺🇸Bellbrook, Ohio, United States
Integris Family Care South
🇺🇸Oklahoma, Oklahoma, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Integris Family Care Yukon
🇺🇸Yukon, Oklahoma, United States
Williamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
Village Family Practice
🇺🇸Houston, Texas, United States
Southwest Clinical Research Centers, Llc
🇺🇸Pearland, Texas, United States
Local Institution
🇵🇷San Juan, Puerto Rico
Torrance Clinical Research
🇺🇸Lomita, California, United States
Clinical Therapeutics Corporation
🇺🇸Coral Gables, Florida, United States
Integrated Medical Group Pc/Fleetwood Clinical Research
🇺🇸Fleetwood, Pennsylvania, United States