A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
- Conditions
- Diabetes
- Interventions
- Registration Number
- NCT00313313
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes
- 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 (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 768
- Type 2 Diabetes.
- Treated with a sulfonylurea for at least 2 months.
- Inadequate blood sugar control.
- Are not on any other medications to lower blood sugar.
- No major heart, liver or kidney problems.
- Women not pregnant or breast feeding.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) Saxagliptin Metformin 500-2500 mg (as needed) Placebo + Glyburide 7.5 mg (C) Glyburide Metformin 500-2500 mg (as needed) Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) Metformin Metformin 500-2500 mg (as needed) Saxagliptin 5 mg + Glyburide 7.5 mg (B) Glyburide Metformin 500-2500 mg (as needed) Saxagliptin 5 mg + Glyburide 7.5 mg (B) Metformin Metformin 500-2500 mg (as needed) Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) Glyburide Metformin 500-2500 mg (as needed) Saxagliptin 5 mg + Glyburide 7.5 mg (B) Saxagliptin Metformin 500-2500 mg (as needed) Placebo + Glyburide 7.5 mg (C) Placebo Metformin 500-2500 mg (as needed) Placebo + Glyburide 7.5 mg (C) Metformin Metformin 500-2500 mg (as needed)
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (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 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.
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 plus glyburide versus placebo plus upward titrated glyburide 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 values.
Trial Locations
- Locations (55)
Stewart Medical Group
🇺🇸Alhambra, California, United States
Valley Research
🇺🇸Fresno, California, United States
Randall Shue, D.O.
🇺🇸Los Angeles, California, United States
Banksville Medical Pc
🇺🇸Pittsburgh, Pennsylvania, United States
University Of Miami Diabetes Research Inst.
🇺🇸Miami, Florida, United States
Texas Center For Drug Development, P.A.
🇺🇸Houston, Texas, United States
Diabetes & Glandular Disease Research Assoc, Pa
🇺🇸San Antonio, Texas, United States
Reserach Solutions, Llc
🇺🇸Jonesboro, Arkansas, United States
Searcy Medical Center
🇺🇸Searcy, Arkansas, United States
Southland Clinical Research Center, Inc.
🇺🇸Fountain Valley, California, United States
Clinical Trials Research
🇺🇸Roseville, California, United States
Christiana Care Research Institute
🇺🇸Newark, Delaware, United States
New West Physicians
🇺🇸Golden, Colorado, United States
Family Care Assoc & Emerald Care Res Grp
🇺🇸Chipley, Florida, United States
Phoenix Internal Medicine Associates, Llc
🇺🇸Waterbury, Connecticut, United States
Central Florida Clinical Trials
🇺🇸Altamonte Springs, Florida, United States
Atlanta Pharmaceutical Research Center, Inc
🇺🇸Dunwoody, Georgia, United States
Albert J Weisbrot,Md&Assoc Inc
🇺🇸Mason, Ohio, United States
Coordinators Plus, Llc
🇺🇸Eugene, Oregon, United States
Dr Bahagwan Dass Md
🇺🇸Youngstown, Ohio, United States
Guthrie Clinic, Ltd
🇺🇸Sayre, Pennsylvania, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
S.A.M. Clinical Research Center
🇺🇸San Antonio, Texas, United States
Southeastern Research Assoc
🇺🇸Taylors, South Carolina, United States
Capital Medical Clinic, Llp
🇺🇸Austin, Texas, United States
Breath Of Life Research Institute
🇺🇸Katy, Texas, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Local Institution
🇨🇳Taipei, Taiwan
Office Of Dr. Gray
🇺🇸Spokane, Washington, United States
Advanced Healthcare S.C.
🇺🇸Milwaukee, Wisconsin, United States
Nevada Alliance Against Diabetes
🇺🇸North Las Vegas, Nevada, United States
Oklahoma Cardiovascular And Hypertension Center
🇺🇸Oklahoma City, Oklahoma, United States
Fpa Clinical Research
🇺🇸Kissimmee, Florida, United States
Cny Family Care
🇺🇸East Syracuse, New York, United States
Clinical Therapeutics Corporation
🇺🇸Coral Gables, Florida, United States
Emerald Coast Research Group
🇺🇸Marianna, Florida, United States
Family Medical Center Of Hart Co.
🇺🇸Munfordville, Kentucky, United States
Mountain Top Clinical Research Center
🇺🇸Sparta, North Carolina, United States
Cedar-Crosse Research Ctr
🇺🇸Chicago, Illinois, United States
Va Medical Center
🇺🇸Kansas City, Missouri, United States
Physicians Research Center
🇺🇸Toms River, New Jersey, United States
Diabetes & Endocrinology Consultants, Pc
🇺🇸Morehead City, North Carolina, United States
Regional Physicians Research
🇺🇸High Point, North Carolina, United States
Columbia Medical Practice
🇺🇸Columbia, Maryland, United States
St. Louis Center For Clinical Research
🇺🇸St. Louis, Missouri, United States
Daystar Clinical Research, Inc.
🇺🇸Akron, Ohio, United States
Med Res Assoc Charlotte
🇺🇸Charlotte, North Carolina, United States
Utica Park Clinic
🇺🇸Tulsa, Oklahoma, United States
Integris Family Care Yukon
🇺🇸Yukon, Oklahoma, United States
Upstate Pharmaceutical Research
🇺🇸Simsonville, South Carolina, United States
Oregon Clinical Research
🇺🇸Portland, Oregon, United States
Pearl Clinical Research
🇺🇸Norristown, Pennsylvania, United States
Community Health Care
🇺🇸Canal Fulton, Ohio, United States
Triphase Research, Ltd.
🇺🇸Franklin, Ohio, United States
Metrolina Internal Medicine
🇺🇸Charlotte, North Carolina, United States