Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Key facts

Study ID

NCT00918138

Run by

AstraZeneca

People needed

219

Starts

2009-08-01

Expected to finish

2010-05-01

Last updated by the study team

2015-05-21

Who can join

Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes
• 18-78 years of age
• Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
• Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
• Fasting C-peptide: ≥1.0 ng/mL
• FPG≥126 mg/dl obtained at the Day -7 visit
• Body mass index (BMI): ≤ 40kg/m²
• A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization

You may not qualify if…

• Women of childbearing potential unable or unwilling to use acceptable birth control
• Women who are pregnant or breastfeeding
• Significant cardiovascular history
• Active liver disease
• Renal impairment

Where it is running

• Dedicated Phase I, Inc. — Phoenix, Arizona, United States
• Pacific Sleep Medicine Services (Avastra Clinical Trials) — Redlands, California, United States
• Orange County Research Center — Tustin, California, United States
• Clinical Research Of South Florida — Coral Gables, Florida, United States
• Palm Springs Research Institute — Hialeah, Florida, United States
• Healthcare Clinical Data, Inc. — North Miami, Florida, United States
• River Birch Research Alliance, Llc — Blue Ridge, Georgia, United States
• Jasper Clinic, Inc. — Kalamazoo, Michigan, United States
• Clinilabs, Inc. — New York, New York, United States
• Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States
• Clinical Trials Of Texas Inc. — San Antonio, Texas, United States
• Advanced Clinical Research — West Jordan, Utah, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Beersheba, Israel
• Local Institution — Holon, Israel
• Local Institution — Kfar Saba, Israel
• Local Institution — Safed, Israel
• Local Institution — Durango, Durango, Mexico
• Local Institution — Durango, Durango, Mexico
• Local Institution — Monterrey, Nuevo León, Mexico

Full record on ClinicalTrials.gov

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