Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00614939

D1680C00007

EudraCT number 2007-004951-12

Details and patient eligibility

About

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.

Enrollment: 572 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with type 2 diabetes
• Documented history of CrCl <50 ml/min within the 3 months prior to enrollment
• HbA1c ≥7.0% and ≤11.0%

Exclusion criteria

• Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
• Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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572 participants in 2 patient groups

Saxa

Experimental group

Description:

Saxagliptin

Treatment:

Drug: Saxagliptin

Placebo

No Intervention group

Description:

Placebo to match

Treatment:

Drug: Placebo