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

Phase 3

Completed

Interventions: Drug: Saxagliptin plus metformin IR
Drug: Placebo plus metformin IR

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Saxagliptin plus metformin IR	Saxagliptin plus metformin IR	-
Placebo plus metformin IR	Placebo plus metformin IR	-

Primary Outcome Measures

Name	Time	Method
Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12	Baseline, Week 12	Mean change was adjusted for baseline.

Secondary Outcome Measures

Name	Time	Method
Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)	Baseline, Week 12	Mean change was adjusted for baseline.
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12	Week 12	Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12	Week 12	Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)

Locations (26): 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
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John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States