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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo plus metformin IR; Drug: Saxagliptin plus metformin IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00885378

EUDRACT #: 2009-010224-25

CV181-080

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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166 participants in 2 patient groups, including a placebo group

Saxagliptin plus metformin IR

Active Comparator group

Treatment:

Drug: Saxagliptin plus metformin IR

Placebo plus metformin IR

Placebo Comparator group

Treatment:

Drug: Placebo plus metformin IR