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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,282
Tablets, Oral, 5mg , Once daily, 24 weeks
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Tablets, Oral, 10mg , Once daily, 24 weeks
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.
Time frame: Baseline (Week 0) and at Week 24
Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.
Time frame: Baseline (Week 0) and at Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.
Time frame: Baseline (Week 0) and at Week 24
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Time frame: At Week 24
Adjusted Mean Change From Baseline in Body Weight at Week 24
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.
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Tablets, Oral, 0mg, Once daily, 24 weeks
Tablets, Oral, 0mg, Once daily, 24 weeks
Central Alabama Research
Birmingham, Alabama, United States
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
...and 129 more locations
Time frame: Baseline (Week 0) and at Week 24