Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683657

CV181-066

Eudract-2008-000976-26

Details and patient eligibility

About

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Enrollment: 93 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18- and ≤77-years-old
• Type 2 diabetes
• Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
• Glycosylated hemoglobin (A1C) ≥7% and ≤10%
• Body mass index (BMI) ≤40 kg/m2

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: Double Blind

---

93 participants in 2 patient groups, including a placebo group

Saxagliptin 5 mg + Metformin

Experimental group

Treatment:

Drug: Saxagliptin

Placebo + Metformin

Placebo Comparator group

Treatment:

Drug: Placebo