Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes

Completed · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy

Key facts

Study ID

NCT01864174

Run by

Bristol-Myers Squibb

People needed

1736

Starts

2013-06-20

Expected to finish

2016-06-01

Last updated by the study team

2019-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, aged ≥18 years old at time of enrollment
• Treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (HbA1c ≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone
• Women must have a negative serum or urine test within 24 hours prior to start of investigational product

You may not qualify if…

• History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma
• Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with >10% weight loss during last 3 months
• Serum creatinine ≥1.50 mg/dL (133 μmol/L) for male subjects; serum creatinine ≥1.40 mg/dL (124 μmol/L for female subjects)

Where it is running

• Terence T. Hart, Md — Muscle Shoals, Alabama, United States
• Clini Res Advantage Desert Clin Res, Llc — Mesa, Arizona, United States
• Clinical Res Advantage Central — Phoenix, Arkansas, United States
• Marin Endocrine Care And Research, Inc. — Greenbrae, California, United States
• Torrance Clinical Research Institute Inc. — Lomita, California, United States
• Actca — Los Angeles, California, United States
• National Research Institute — Los Angeles, California, United States
• R. Srinivasan, M.D., Inc. — Monterey Park, California, United States
• Diabetes Medical Center Of California — Northridge, California, United States
• Valley Clinical Trials — Northridge, California, United States
• Center For Clinical Trials Of Sacramento, Inc. — Sacramento, California, United States
• Clinical Research Advantage — Colorado Springs, Colorado, United States
• Clinical Research Advantage — Colorado Springs, Colorado, United States
• Colorado Springs Family Practice — Colorado Springs, Colorado, United States
• Clinical Research Advantage, Inc/Co Springs Health Partners, Briar — Colorado Springs, Colorado, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• Family Care Partners — Jacksonville, Florida, United States
• Omega Research Consultants, Llc — Orlando, Florida, United States
• Palm Harbor Medical Associates — Palm Harbor, Florida, United States
• Gulfcoast Medical Research Center, Llc — Tampa, Florida, United States
• Cedar-Crosse Research Ctr — Chicago, Illinois, United States
• Clinical Research Advantage, Inc./Family Medicine Associates — Evansville, Indiana, United States
• American Health Network Of In Llc — Muncie, Indiana, United States
• Columbia Medical Practice — Columbia, Maryland, United States
• Central Alabama Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.