Official Title: “A 24-Week International, Multi-Centre, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: Saxagliptin
  • Oral tablet, one daily for 24 weeks
• Drug: Placebo
  • oral tablet, once daily for 24 weeks
• Drug: Metformin
  • oral tablet, once daily for 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Metformin + Saxagliptin
• Placebo Comparator: 2
  • Metformin + Placebo

Primary Measures

• Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) after 24 weeks oral administration
  • Time Frame: Multiple time points during 24 weeks
    Safety Issue?: No

Secondary Measures

• Compare the effects of Saxagliptin versus placebo given as add on therapy to metformin during 24 weeks.
  • Time Frame: Multiple time points during 24 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Peter Ohman, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661362

Study ID Number: D1680C00006

ClinicalTrials.gov Identifier: NCT00661362

Health Authority: China: State Food and Drug Administration