Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
- Registration Number
- NCT00316082
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise
- 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 metformin (rescue medication) added onto their blinded study medication
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
- Type 2 diabetes
- Inadequate blood sugar control
- Previous treatment for diabetes
- Current treatment with other medications to lower blood sugar
- Major heart, liver or kidney problems
- Women who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (E) Placebo PLUS open-label metformin (as needed as rescue medication) Saxagliptin 5 mg QAM (C) Saxagliptin PLUS open-label metformin (as needed as rescue medication) Saxagliptin 5 mg QPM (D) Saxagliptin PLUS open-label metformin (as needed as rescue medication) Saxagliptin 2.5 mg QAM (A) metformin PLUS open-label metformin (as needed as rescue medication) Saxagliptin 5 mg QAM (C) metformin PLUS open-label metformin (as needed as rescue medication) Saxagliptin 2.5 mg titrated to 5 mg QAM (B) Saxagliptin PLUS open-label metformin (as needed as rescue medication) Saxagliptin 2.5 mg QAM (A) Saxagliptin PLUS open-label metformin (as needed as rescue medication) Placebo (E) metformin PLUS open-label metformin (as needed as rescue medication) Saxagliptin 2.5 mg titrated to 5 mg QAM (B) metformin PLUS open-label metformin (as needed as rescue medication) Saxagliptin 5 mg QPM (D) metformin PLUS open-label metformin (as needed as rescue medication)
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1 (A1C) at Week 24 Baseline, Week 24 Mean change from baseline in A1C at Week 24, adjusted for baseline value.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving A1C < 7% at Week 24 Week 24 Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo 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 Baseline, Week 24 Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM Baseline, Week 24 Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 Baseline, Week 24 Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Trial Locations
- Locations (51)
Southland Clinical Research Center, Inc.
🇺🇸Fountain Valley, California, United States
Winston Technology, Inc.
🇺🇸Haleyville, Alabama, United States
Clinical Reseacrh Advantage/ Brown Family Medicine
🇺🇸Mesa, Arizona, United States
Medical Group Of Encino
🇺🇸Encino, California, United States
Tomac, Inc.
🇺🇸Columbiana, Alabama, United States
Strategos Medical Group
🇺🇸Bakersfield, California, United States
Valley Research
🇺🇸Fresno, California, United States
Diabetes Medical Center Of California
🇺🇸Northridge, California, United States
In Private Prictice Clinic
🇺🇸Pico Rivera, California, United States
Hudson Valley Clinical Research Center
🇺🇸Kingston, New York, United States
Wells Institute For Health Awareness
🇺🇸Kettering, Ohio, United States
Alpha Therapy Research Center
🇺🇸Corpus Christi, Texas, United States
Taylor/Wade Medical
🇺🇸Bountiful, Utah, United States
Accelovance
🇺🇸Oklahoma City, Oklahoma, United States
Banksville Medical, Pc
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Center For Drug Development, P.A.
🇺🇸Houston, Texas, United States
Abbott Clinical Research Group, Inc
🇺🇸San Antonio, Texas, United States
University Family Healthcare, Pa
🇺🇸Sarasota, Florida, United States
Fleetwood Clinical Research
🇺🇸Fleetwood, Pennsylvania, United States
Southwind Medical Specialist
🇺🇸Memphis, Tennessee, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Middle Tyger Family Medicine
🇺🇸Duncan, South Carolina, United States
Community Health Care, Inc.
🇺🇸Barberton, Ohio, United States
Southeastern Research Assoc
🇺🇸Taylors, South Carolina, United States
Clinical Research Limited
🇺🇸Canton, Ohio, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Pinnacle Medical Research
🇺🇸Overland Park, Kansas, United States
Central Florida Clinical Trials, Inc.
🇺🇸Altamonte Springs, Florida, United States
Physicians Research Center
🇺🇸Toms River, New Jersey, United States
Premier Healthcare
🇺🇸St. Petersburg, Florida, United States
Kansas City University Of Medicine And Biosciences
🇺🇸Kansas City, Missouri, United States
San Jose Clinical Research, Inc.
🇺🇸San Jose, California, United States
Primary Care Physicians, Pc
🇺🇸Wentzville, Missouri, United States
Neem Research Group Of Charlotte
🇺🇸Charlotte, North Carolina, United States
Clinical Research Source, Inc
🇺🇸Perrysburg, Ohio, United States
Cumberland Valley Endocrinology Center, Llc
🇺🇸Carlisle, Pennsylvania, United States
Versoza & Ungab Internal Medicine Associates
🇺🇸Bartlett, Tennessee, United States
Integris Family Care South
🇺🇸Oklahoma City, Oklahoma, United States
Village Family Practice
🇺🇸Houston, Texas, United States
The Office Of Patricia Buchanan
🇺🇸Eugene, Oregon, United States
Precision Family Medicine
🇺🇸Carrollton, Texas, United States
Biomedical Research Associates, Llc
🇺🇸Shippensburg, Pennsylvania, United States
Local Institution
🇨🇳Tao-Yuan County, Taiwan
Optimum Clinical Research
🇺🇸Salt Lake City, Utah, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Spokane Internal Medicine
🇺🇸Spokane, Washington, United States
Collierville Medical Specialist
🇺🇸Collierville, Tennessee, United States
Med-South Research
🇺🇸Memphis, Tennessee, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Rx For Life, Inc
🇺🇸Cudahy, California, United States
Diabetes Center- East Carolina University
🇺🇸Greenville, North Carolina, United States