Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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
Outcome Measures for this Clinical Trial
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
- Time Frame: Multiple time points during 24 weeks
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
- Time Frame: Multiple time points during 24 weeks
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Peter Ohman, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00661362
