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
๐บ๐ธAlhambra, California, United States
Valley Research
๐บ๐ธFresno, California, United States
Randall Shue, D.O.
๐บ๐ธLos Angeles, California, United States
Banksville Medical Pc
๐บ๐ธPittsburgh, Pennsylvania, United States
University Of Miami Diabetes Research Inst.
๐บ๐ธMiami, Florida, United States
Texas Center For Drug Development, P.A.
๐บ๐ธHouston, Texas, United States
Diabetes & Glandular Disease Research Assoc, Pa
๐บ๐ธSan Antonio, Texas, United States
Reserach Solutions, Llc
๐บ๐ธJonesboro, Arkansas, United States
Searcy Medical Center
๐บ๐ธSearcy, Arkansas, United States
Southland Clinical Research Center, Inc.
๐บ๐ธFountain Valley, California, United States
Clinical Trials Research
๐บ๐ธRoseville, California, United States
Christiana Care Research Institute
๐บ๐ธNewark, Delaware, United States
New West Physicians
๐บ๐ธGolden, Colorado, United States
Family Care Assoc & Emerald Care Res Grp
๐บ๐ธChipley, Florida, United States
Phoenix Internal Medicine Associates, Llc
๐บ๐ธWaterbury, Connecticut, United States
Central Florida Clinical Trials
๐บ๐ธAltamonte Springs, Florida, United States
Atlanta Pharmaceutical Research Center, Inc
๐บ๐ธDunwoody, Georgia, United States
Albert J Weisbrot,Md&Assoc Inc
๐บ๐ธMason, Ohio, United States
Coordinators Plus, Llc
๐บ๐ธEugene, Oregon, United States
Dr Bahagwan Dass Md
๐บ๐ธYoungstown, Ohio, United States
Guthrie Clinic, Ltd
๐บ๐ธSayre, Pennsylvania, United States
Spartanburg Medical Research
๐บ๐ธSpartanburg, South Carolina, United States
S.A.M. Clinical Research Center
๐บ๐ธSan Antonio, Texas, United States
Southeastern Research Assoc
๐บ๐ธTaylors, South Carolina, United States
Capital Medical Clinic, Llp
๐บ๐ธAustin, Texas, United States
Breath Of Life Research Institute
๐บ๐ธKaty, Texas, United States
Tidewater Integrated Medical Research
๐บ๐ธVirginia Beach, Virginia, United States
Local Institution
๐จ๐ณTaipei, Taiwan
Office Of Dr. Gray
๐บ๐ธSpokane, Washington, United States
Advanced Healthcare S.C.
๐บ๐ธMilwaukee, Wisconsin, United States
Nevada Alliance Against Diabetes
๐บ๐ธNorth Las Vegas, Nevada, United States
Oklahoma Cardiovascular And Hypertension Center
๐บ๐ธOklahoma City, Oklahoma, United States
Fpa Clinical Research
๐บ๐ธKissimmee, Florida, United States
Cny Family Care
๐บ๐ธEast Syracuse, New York, United States
Clinical Therapeutics Corporation
๐บ๐ธCoral Gables, Florida, United States
Emerald Coast Research Group
๐บ๐ธMarianna, Florida, United States
Family Medical Center Of Hart Co.
๐บ๐ธMunfordville, Kentucky, United States
Mountain Top Clinical Research Center
๐บ๐ธSparta, North Carolina, United States
Cedar-Crosse Research Ctr
๐บ๐ธChicago, Illinois, United States
Va Medical Center
๐บ๐ธKansas City, Missouri, United States
Physicians Research Center
๐บ๐ธToms River, New Jersey, United States
Diabetes & Endocrinology Consultants, Pc
๐บ๐ธMorehead City, North Carolina, United States
Regional Physicians Research
๐บ๐ธHigh Point, North Carolina, United States
Columbia Medical Practice
๐บ๐ธColumbia, Maryland, United States
St. Louis Center For Clinical Research
๐บ๐ธSt. Louis, Missouri, United States
Daystar Clinical Research, Inc.
๐บ๐ธAkron, Ohio, United States
Med Res Assoc Charlotte
๐บ๐ธCharlotte, North Carolina, United States
Utica Park Clinic
๐บ๐ธTulsa, Oklahoma, United States
Integris Family Care Yukon
๐บ๐ธYukon, Oklahoma, United States
Upstate Pharmaceutical Research
๐บ๐ธSimsonville, South Carolina, United States
Oregon Clinical Research
๐บ๐ธPortland, Oregon, United States
Pearl Clinical Research
๐บ๐ธNorristown, Pennsylvania, United States
Community Health Care
๐บ๐ธCanal Fulton, Ohio, United States
Triphase Research, Ltd.
๐บ๐ธFranklin, Ohio, United States
Metrolina Internal Medicine
๐บ๐ธCharlotte, North Carolina, United States