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 (HbA1c 7.0-9.5%)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00728351
First received: July 31, 2008
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: vildagliptin + metformin Drug: metformin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- FPG reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Body weight change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Changes in the fasting lipid profile [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 317 |
| Study Start Date: | June 2008 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: vildagliptin + metformin | Drug: vildagliptin + metformin |
| Active Comparator: metformin |
Drug: metformin
1000 bid metformin
|
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00728351
Show 63 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728351
Show 63 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00728351 History of Changes |
| Other Study ID Numbers: | CLMF237A2309 |
| Study First Received: | July 31, 2008 |
| Last Updated: | January 2, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Type 2 diabetes, vildagliptin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Metformin Vildagliptin |
Dipeptidyl-Peptidase IV Inhibitors Enzyme Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors |
ClinicalTrials.gov processed this record on March 01, 2015