A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
- Conditions
- Diabetes
- Interventions
- Registration Number
- NCT00327015
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone
- Detailed Description
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1306
- Type 2 diabetes
- Inadequate blood sugar control
- No current treatment with other medications to lower blood sugar
- Major heart, liver or kidney problems
- Pregnant or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saxagliptin and Placebo (C) Placebo PLUS open-label pioglitazone (as needed as rescue medication) Metformin and Placebo (D) Placebo PLUS open-label pioglitazone (as needed as rescue medication) Saxagliptin and Metformin (B) pioglitazone PLUS open-label pioglitazone (as needed as rescue medication) Saxagliptin and Metformin (A) Saxagliptin PLUS open-label pioglitazone (as needed as rescue medication) Saxagliptin and Metformin (A) Metformin PLUS open-label pioglitazone (as needed as rescue medication) Saxagliptin and Metformin (A) pioglitazone PLUS open-label pioglitazone (as needed as rescue medication) Saxagliptin and Metformin (B) Saxagliptin PLUS open-label pioglitazone (as needed as rescue medication) Saxagliptin and Metformin (B) Metformin PLUS open-label pioglitazone (as needed as rescue medication) Saxagliptin and Placebo (C) pioglitazone PLUS open-label pioglitazone (as needed as rescue medication) Saxagliptin and Placebo (C) Saxagliptin PLUS open-label pioglitazone (as needed as rescue medication) Metformin and Placebo (D) Metformin PLUS open-label pioglitazone (as needed as rescue medication) Metformin and Placebo (D) pioglitazone PLUS open-label pioglitazone (as needed as rescue medication)
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy Baseline, Week 24 Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy Baseline, Week 24 Mean change from baseline in A1C at Week 24, adjusted for baseline value.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy Baseline, Week 24 Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy Baseline, Week 24 Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy Week 24 Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy Week 24 Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy Baseline, Week 24 Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy Baseline, Week 24 Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy Week 24 Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy Week 24 Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy Week 24 Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy Week 24 Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone.
Trial Locations
- Locations (47)
Newark Physician Associates
🇺🇸Newark, Ohio, United States
East Bay Clinical Trial Center
🇺🇸Concord, California, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Coastal Biomedical Research Inc
🇺🇸Santa Monica, California, United States
St. Joseph'S Medical Associates
🇺🇸Stockton, California, United States
Florida Research Network, Llc
🇺🇸Gainesville, Florida, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Med-Cure Primary Care Physicians
🇺🇸Rosenberg, Texas, United States
Clinical Therapeutics Corporation
🇺🇸Coral Gables, Florida, United States
Internal Medicine Of Greer
🇺🇸Greer, South Carolina, United States
Fpa Clinical Research
🇺🇸Kissimmee, Florida, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Middle Georgia Drug Study Center, Llc
🇺🇸Perry, Georgia, United States
Emerald Coast Research Group
🇺🇸Marianna, Florida, United States
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
Adviso Medical Research, Llc
🇺🇸Chicago, Illinois, United States
Deerbrook Medical Associates
🇺🇸Vernon Hills, Illinois, United States
Physicians Research Group
🇺🇸Indianapolis, Indiana, United States
Professional Network Research Of Kansas
🇺🇸Wichita, Kansas, United States
Midwest Regional Research, Inc.
🇺🇸Bellbrook, Ohio, United States
Non Invasive Cardiovascular Pa
🇺🇸Houston, Texas, United States
Safe Harbor Clinical Research
🇺🇸E. Providence, Rhode Island, United States
Frontier Clinical Research, Llc.
🇺🇸Memphis, Tennessee, United States
Endocrine Associates
🇺🇸Houston, Texas, United States
Advances In Health,Inc
🇺🇸Houston, Texas, United States
Juno Research, Llc
🇺🇸Houston, Texas, United States
Middle Tennessee Clinical Research
🇺🇸Fayetteville, Tennessee, United States
Tiena Health Research
🇺🇸Irving, Texas, United States
Diabetes Center Of The Southwest
🇺🇸Midland, Texas, United States
Pearland Primary Care Associates, Llp
🇺🇸Pearland, Texas, United States
Gsa Research
🇺🇸San Antonio, Texas, United States
Covenant Clinical Research, Pa
🇺🇸San Antonio, Texas, United States
Local Institution
🇺🇦Ternopil, Ukraine
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Medical Arts Research Collaborative, Llc
🇺🇸Excelsior Springs, Missouri, United States
Nevada Alliance Against Diabetes
🇺🇸N. Las Vegas, Nevada, United States
Durham Internal Medicine Assoc.
🇺🇸Durham, North Carolina, United States
Down East Medical Associates
🇺🇸Morehead City, North Carolina, United States
Massillon Family Practice
🇺🇸Massillon, Ohio, United States
Your Diabetes Endocrine Nutrition Group
🇺🇸Mentor, Ohio, United States
Capital Medical Clinic, Llp
🇺🇸Austin, Texas, United States
Hill Country Medical Associates
🇺🇸New Braunfels, Texas, United States
S.A.M. Clinical Research Center
🇺🇸San Antonio, Texas, United States
Seven Corners Medical Research Center
🇺🇸Falls Church, Virginia, United States
Salem Va Medical Ctr Research & Devlopment
🇺🇸Salem, Virginia, United States
Physicians Clinic Of Spokane
🇺🇸Spokane, Washington, United States