The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy...
Date First Received: July 31, 2008
Last Updated: March 11, 2009
Verified by: Novartis, March 2009
Clinical Trial Phase: Phase 3 | Start Date: June 2008
Overall Status: Recruiting
Estimated Enrollment: 300
Brief Summary
Official Title: “A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.”
Condition Keyword(s):
Intervention(s):
The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: October 2009
Intervention(s) in this Clinical Trial
- Drug: vildagliptin, metformin
- vildagliptin, metformin fixed dose combination 25/1000 mg bid
- Drug: metformin
- 1000 bid metformin
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 2
- 1000 bid metformin
- Experimental: 1
- vildagliptin metformin fixed dose combination 25/1000 mg bid
Outcome Measures for this Clinical Trial
Primary Measures
- HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
Secondary Measures
- FPG reduction
- Safety and tolerability
- Body weight change from baseline
- Changes in the fasting lipid profile
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- History of T2DM treated with Metformin
Exclusion Criteria:
- FPG >= 260 mg/dL (14.4mmol/L)
- Other protocol-defined inclusion/exclusion criteria may apply
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 78 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Overall Contact: Novartis Pharmaceuticals 862-778-8300
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00728351
Study ID Number: CLMF237A2309
ClinicalTrials.gov Identifier: NCT00728351
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
