A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
NCT ID: NCT00468039
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
94 participants
INTERVENTIONAL
2007-03-06
2008-06-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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vildagliptin + metformin
vildagliptin + metformin
Interventions
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vildagliptin + metformin
Eligibility Criteria
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Inclusion Criteria
* 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
* History of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agent
18 Years
78 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States
Countries
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References
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Bosi E, Dotta F, Jia Y, Goodman M. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 May;11(5):506-15. doi: 10.1111/j.1463-1326.2009.01040.x. Epub 2009 Mar 23.
Related Links
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Results for CLMF237A2302S1 from the Novartis Clinical Trials website
Other Identifiers
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CLMF237A2302S1
Identifier Type: -
Identifier Source: org_study_id