Saxagliptin Triple Oral Therapy
Study identifier:D1680L00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, Placebo
Sex
All
Actual Enrollment
257
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Jun 2011
Study Completion Date: 01 Jun 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Saxagliptin 5 mg once daily | Drug: Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally Other Name: Onglyza |
| Placebo Comparator: Placebo once daily | Drug: Placebo tablet once daily for 24 weeks to be taken orally |
Contacts
Investigators
Principal Investigator
Jayanti Visvanthan
AstraZeneca
