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
PHASE4
46 participants
INTERVENTIONAL
2010-10-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vildagliptin
Vildagliptin
other Oral Antidiabetic Drug in a different therapeutic class
"Usual Care"
Interventions
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Vildagliptin
"Usual Care"
Eligibility Criteria
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Inclusion Criteria
* HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months.
Exclusion Criteria
* BMI \< 22 and ≥ 45 kg/m2
* Secondary T2 DM
* Hepatic failure, moderate/severe renal failure (Cl \< 50 ml/min) and CHF III \& IV
65 Years
80 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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Novartis Investigative Site
Armentières, , France
Novartis Investigative Site
Brest, , France
Novartis Investigative Site
Caen, , France
Novartis Investigative Site
Creil, , France
Novartis Investigative Site #2
Paris, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Pau, , France
Novartis Investigative Site
Saint-Jean-de-la-Ruelle, , France
Novartis Investigative Site
Strasbourg, , France
Novartis Investigative Site
Strasbourg, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Tours, , France
Novartis Investigative Site
Versailles, , France
Novartis Investigative Site
Vénissieux, , France
Novartis Investigative Site #2
Vénissieux, , France
Countries
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References
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Penfornis A, Bourdel-Marchasson I, Quere S, Dejager S. Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. Diabetes Metab. 2012 Dec;38(6):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18.
Other Identifiers
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CLAF237AFR03
Identifier Type: -
Identifier Source: org_study_id
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