Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin XR; Drug: Placebo matching Saxagliptin; Drug: Saxagliptin; Drug: Placebo matching Metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918138

CV181-085

Details and patient eligibility

About

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Enrollment: 219 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 dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
• Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
• Fasting C-peptide: ≥1.0 ng/mL
• FPG≥126 mg/dl obtained at the Day -7 visit
• Body mass index (BMI): ≤ 40kg/m²
• A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization

Exclusion criteria

• Women of childbearing potential unable or unwilling to use acceptable birth control
• Women who are pregnant or breastfeeding
• Significant cardiovascular history
• Active liver disease
• Renal impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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219 participants in 2 patient groups

Saxagliptin + Metformin XR + matching Metformin XR placebo

Experimental group

Description:

(Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo)

Treatment:

Drug: Placebo matching Metformin XR

Drug: Saxagliptin

Drug: Metformin XR

Drug: Metformin XR

Metformin XR + Metformin XR + matching Saxagliptin placebo

Active Comparator group

Description:

(Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo)

Treatment:

Drug: Placebo matching Saxagliptin

Drug: Metformin XR

Drug: Metformin XR