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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00728351 |
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Date of registration:
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31/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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. |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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317 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00728351 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Germany
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Hungary
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Poland
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
78 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: metformin
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Drug: vildagliptin + metformin
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Primary Outcome(s)
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HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Body weight change from baseline
[Time Frame: 24 weeks]
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FPG reduction
[Time Frame: 24 weeks]
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Safety and tolerability
[Time Frame: 24 weeks]
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Changes in the fasting lipid profile
[Time Frame: 24 weeks]
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Secondary ID(s)
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CLMF237A2309
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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