Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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 with inadequate glycaemic control with diet and exercise.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Saxagliptin

Criteria

Inclusion Criteria:

• Diagnosed with Type 2 diabetes

• Patients should be drug naïve ie, not received medical treatment for diabetes,

• HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

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