Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Key facts

Study ID

NCT00885378

Run by

AstraZeneca

People needed

166

Starts

2009-05-01

Expected to finish

2010-02-01

Last updated by the study team

2015-06-01

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 twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
• A1C: 7-10%
• C-peptide: ≥ 0.8 ng/mL
• Body mass index (BMI): ≤45 kg/m\^2

You may not qualify if…

• Women of childbearing potential unable or unwilling to use acceptable birth control
• Women who are pregnant or breastfeeding
• Fasting plasma glucose (FPG) >270 mg/dL
• Significant cardiovascular history
• Symptoms of poorly controlled diabetes
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Insulin therapy within one year of screening
• Cardiovascular even within the prior 6 months
• New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction <=40%
• Significant history of renal or hepatic disease
• History of a psychiatric disorder, alcohol or drug abuse within the previous year
• Treatment with potent CYP3A4 inhibitors or inducers
• Immunocompromised participants
• Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests

Where it is running

• John Muir Physician Network Clinical Research Center — Concord, California, United States
• Southland Clinical Research Center, Inc. — Fountain Valley, California, United States
• Torrance Clinical Research — Lomita, California, United States
• Ritchken & First M.D.'S — San Diego, California, United States
• Central Florida Clinical Trials, Inc. — Altamonte Springs, Florida, United States
• Family Care Associates Of Nw Florida — Chipley, Florida, United States
• Clinical Therapeutics Corporation — Coral Gables, Florida, United States
• Nextphase Clinical Trials, Inc. — Miami, Florida, United States
• Middle Georgia Drug Study Center, Llc — Perry, Georgia, United States
• Louisiana Heart Center Research — Slidell, Louisiana, United States
• Jackson Clinic — Rolling Fork, Mississippi, United States
• Community Health Care Of Manchester — Akron, Ohio, United States
• Midwest Regional Research, Inc. — Bellbrook, Ohio, United States
• Wells Institute For Health Awareness — Kettering, Ohio, United States
• Newark Physician Associates — Newark, Ohio, United States
• Integris Family Care South — Oklahoma City, Oklahoma, United States
• Integris Family Care Yukon — Yukon, Oklahoma, United States
• Williamette Valley Clinical Studies — Eugene, Oregon, United States
• Integrated Medical Group Pc/Fleetwood Clinical Research — Fleetwood, Pennsylvania, United States
• Southeastern Research Associates, Inc — Taylors, South Carolina, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Village Family Practice — Houston, Texas, United States
• Southwest Clinical Research Centers, Llc — Pearland, Texas, United States
• Jolene K. Berg, Md., Dgd Research, Inc. — San Antonio, Texas, United States
• Tidewater Integrated Medical Research — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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