Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin; Drug: Placebo; Drug: Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661362

D1680C00006

Details and patient eligibility

About

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.

Enrollment: 570 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Type 2 diabetes
• Treatment with metformin at a stable dose >1500 mg/day
• HbA1c ≥ 7.0% and ≤10.0%

Exclusion criteria

• Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
• Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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570 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Metformin + Saxagliptin

Treatment:

Drug: Saxagliptin

Drug: Metformin

2

Placebo Comparator group

Description:

Metformin + Placebo

Treatment:

Drug: Placebo

Drug: Metformin