Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

Key facts

Study ID

NCT01606007

Run by

AstraZeneca

People needed

1282

Starts

2012-07-01

Expected to finish

2014-01-01

Last updated by the study team

2017-05-15

Who can join

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

You may qualify if…

• Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
• Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
• Body mass index (BMI) ≤ 45.0kg/m2

You may not qualify if…

• Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
• Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
• Hepatic disease
• Cardiovascular disease within 3 months

Where it is running

• Central Alabama Research — Homewood, Alabama, United States
• Terence T. Hart, Md — Muscle Shoals, Alabama, United States
• International Institute Of Clinical Research — Ozark, Alabama, United States
• Clinical Research Advantage — Mesa, Arizona, United States
• Elite Clinical Studies, Llc — Phoenix, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Medical Investigations, Inc. — Little Rock, Arkansas, United States
• Aureus Research, Inc. — Little Rock, Arkansas, United States
• Southland Clinical Research Center, Inc. — Fountain Valley, California, United States
• Torrance Clinical Research — Lomita, California, United States
• National Research Inst — Los Angeles, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Diabetes Medical Center Of California — Northridge, California, United States
• Mehrdad Kevin Ariani Md, Inc. — Northridge, California, United States
• Lucita M. Cruz,Md.,Inc. — Norwalk, California, United States
• Center For Clinical Trials, Llc. — Paramount, California, United States
• Center For Clinical Trials Of Sacramento, Inc. — Sacramento, California, United States
• Trinitas Research, Inc — San Jose, California, United States
• Orange County Research Center — Tustin, California, United States
• Clinical Research Advantage — Colorado Springs, Colorado, United States
• Infocus Clinical Research — Denver, Colorado, United States
• Lynn Institute Of Denver — Denver, Colorado, United States
• Southeast Clinical Research, Llc — Chiefland, Florida, United States
• Clinical Therapeutics Corporation — Coral Gables, Florida, United States
• Central Alabama Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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