Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
NCT ID: NCT00102388
Last Updated: 2016-11-18
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
1092 participants
INTERVENTIONAL
2005-01-31
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
vildagliptin
Gliclazide
Gliclazide
Interventions
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vildagliptin
Gliclazide
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met
Exclusion Criteria
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
18 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 Investigative Site
Investigative Centers, , Germany
Novartis Pharmaceuticals
Basel, , Switzerland
Countries
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References
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Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naive patients with type 2 diabetes. Horm Metab Res. 2009 Dec;41(12):905-9. doi: 10.1055/s-0029-1234042. Epub 2009 Aug 24.
Filozof C, Schwartz S, Foley JE. Effect of vildagliptin as add-on therapy to a low-dose metformin. World J Diabetes. 2010 Mar 15;1(1):19-26. doi: 10.4239/wjd.v1.i1.19.
Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16.
Other Identifiers
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CLAF237A2310
Identifier Type: -
Identifier Source: org_study_id