Overview

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