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

Phase 3

Completed

Interventions: Drug: Saxagliptin
Drug: Metformin XR
Drug: Dapagliflozin
Drug: Placebo matching with Saxagliptin
Drug: Placebo matching with Dapagliflozin

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Arm 2: Dapagliflozin+Metformin XR+Placebo	Placebo matching with Saxagliptin	-
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR	Saxagliptin	-
Arm 1: Saxagliptin+Metformin XR+Placebo	Metformin XR	-
Arm 1: Saxagliptin+Metformin XR+Placebo	Placebo matching with Dapagliflozin	-
Arm 2: Dapagliflozin+Metformin XR+Placebo	Metformin XR	-
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR	Metformin XR	-
Arm 1: Saxagliptin+Metformin XR+Placebo	Saxagliptin	-
Arm 2: Dapagliflozin+Metformin XR+Placebo	Dapagliflozin	-
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR	Dapagliflozin	-

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24	Baseline (Week 0) and 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.

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline (Week 0) and 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.
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])	At Week 24	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.
Adjusted Mean Change From Baseline in Body Weight at Week 24	Baseline (Week 0) and 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.
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 (Week 0) and 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. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.

Locations (73): 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
🇺🇸
Omaha, Nebraska, 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
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Central Alabama Research
🇺🇸Homewood, Alabama, United States