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%)
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ClinicalTrials.gov Identifier: NCT00728351 |
Recruitment Status :
Completed
First Posted : August 5, 2008
Last Update Posted : December 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: vildagliptin + metformin Drug: metformin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 317 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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. |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: vildagliptin + metformin |
Drug: vildagliptin + metformin |
Active Comparator: metformin |
Drug: metformin
1000 bid metformin |
- HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy [ Time Frame: 24 weeks ]
- FPG reduction [ Time Frame: 24 weeks ]
- Safety and tolerability [ Time Frame: 24 weeks ]
- Body weight change from baseline [ Time Frame: 24 weeks ]
- Changes in the fasting lipid profile [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years to 78 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728351

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00728351 |
Other Study ID Numbers: |
CLMF237A2309 |
First Posted: | August 5, 2008 Key Record Dates |
Last Update Posted: | December 19, 2020 |
Last Verified: | January 2013 |
Type 2 diabetes, vildagliptin |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Vildagliptin |
Hypoglycemic Agents Physiological Effects of Drugs Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |