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Main
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Note: This record shows only the 20 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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7 January 2013 |
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Main ID: |
NCT00468039 |
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Date of registration:
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27/04/2007 |
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Primary sponsor: |
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Public title:
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A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
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Scientific title:
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A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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94 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00468039 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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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:
- Male or female (non-fertile or of childbearing potential using a medically approved
birth control method) patients with type 2 diabetes
- Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
- Body mass index 22-40 kg/meter squared
- HbA1c > 11% and/or FPG >270 mg/dL
Exclusion Criteria:
- Pregnant or lactating female
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agent
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: vildagliptin + metformin
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Primary Outcome(s)
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glycosylated hemoglobin (HbA1c)at Baseline and week 24
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Fasting plasma glucose test (FPG) at Baseline and week 24
[Time Frame: 24 weeks]
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HbA1c at Baseline and week 12
[Time Frame: 12 weeks]
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Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks
[Time Frame: 24 weeks]
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Safety assessed by monitoring and recording all adverse events, serious adverse events.
[Time Frame: 24 weeks]
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Weight at baseline and week 24
[Time Frame: 24 weeks]
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Secondary ID(s)
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CLMF237A2302S1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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