Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
NCT ID: NCT00396357
Last Updated: 2020-12-17
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
914 participants
INTERVENTIONAL
2006-10-31
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
TRIPLE
Study Groups
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vildagliptin + metformin
Vildagliptin
Metformin
metformin
Interventions
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Vildagliptin
metformin
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes diagnosis at least 2 months prior to study entry
* Body mass index in the range of 22-45 kg/m2
* HbA1c in the range of 6.5 to 9% inclusive
* Fasting plasma glucose \<270 mg/dL (15 mmol/L)
Exclusion Criteria
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agents
* Congestive heart failure requiring pharmacologic treatment
* Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \>/= 1.5 mg/dl (males) and \>/= 1.4 mg/dl (females)
18 Years
78 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
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
Novartis Investigative Site
Multiple Locations, , Germany
Countries
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Related Links
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Results for CLAF237A23104 from the Novartis Clinical Trials website
Other Identifiers
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CLAF237A23104
Identifier Type: -
Identifier Source: org_study_id