Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
NCT ID: NCT00382096
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
1179 participants
INTERVENTIONAL
2006-09-30
2008-06-03
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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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vildagliptin + Metformin Dose 1
Vildagliptin + Metformin
Vildagliptin + Metformin Dose 2
Vildagliptin + Metformin
Vildagliptin
Vildagliptin
Metformin
Metformin
Interventions
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Vildagliptin
Metformin
Vildagliptin + Metformin
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of T2DM for at least 4 weeks prior to study entry
* Age 18 - 78 years inclusive
* Body mass index (BMI) of 22 - 40 kg/m2
* HbA1c: 7.5 - 11% inclusive
* FPG \<270 mg/dL (15 mmol/L)
Exclusion Criteria
* A history of type 1 diabetes
* Evidence of significant diabetic complications
18 Years
78 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
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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Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Multiple Locations, , Germany
Countries
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Related Links
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Clinical Trial Results for CLMF237A2302 at Novartis Clinical Trials.com
Other Identifiers
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CLMF237A2302
Identifier Type: -
Identifier Source: org_study_id