Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.
NCT ID: NCT01649466
Last Updated: 2016-11-17
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
PHASE4
162 participants
INTERVENTIONAL
2012-08-31
2013-10-31
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
NONE
Study Groups
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Vildagliptin
Patients randomized to the vildagliptin group will receive 50mg vildagliptin once daily add-on to their current glimepiride monotherapy for 24 weeks. No dose titrations are permitted during the study.
LAF237
Vildagliptin will be used as commercially available tablets of 50mg.
Protaphane
Patients randomized to the Protaphane group will receive a individualized dose of Protaphane once daily as bedtime dose. The Protaphane dose will be titrated within the first 4 weeks to reach fasting plasma glucose values below 100 mg/dl.
Protaphane
Protaphane will be used as commercially available injection pens
Interventions
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LAF237
Vildagliptin will be used as commercially available tablets of 50mg.
Protaphane
Protaphane will be used as commercially available injection pens
Eligibility Criteria
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Inclusion Criteria
* Contraindicated or intolerant to take metformin.
* HbA1c of ≥ 7.0% and ≤ 8.5%
* Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled
Exclusion Criteria
* Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month
* Patients taking sulfonylurea for longer than 5 years
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
* pregnancy
18 Years
85 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
Anderbeck, , Germany
Novartis Investigative Site
Augsburg, , Germany
Novartis Investigative Site
Bad Kreuznach, , Germany
Novartis Investigative Site
Bad Oeynhausen, , Germany
Novartis Investigative Site
Balingen, , Germany
Novartis Investigative Site
Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
Novartis Investigative Site
Dortmund, , Germany
Novartis Investigative Site
Dresden, , Germany
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Dresden, , Germany
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Einbeck, , Germany
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Eisleben Lutherstadt, , Germany
Novartis Investigative Site
Elsterwerda, , Germany
Novartis Investigative Site
Essen, , Germany
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Essen, , Germany
Novartis Investigative Site
Fulda, , Germany
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Gelnhausen, , Germany
Novartis Investigative Site
Graben-Neudorf, , Germany
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Grossheirath-Rossach, , Germany
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Herne, , Germany
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Hildesheim, , Germany
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Kassel, , Germany
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Kassel, , Germany
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Kleve, , Germany
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Lienen, , Germany
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Löhne, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Mayen, , Germany
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Mülheim, , Germany
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München, , Germany
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München, , Germany
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Oschatz, , Germany
Novartis Investigative Site
Potsdam, , Germany
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Reinfeld, , Germany
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Saarlouis, , Germany
Novartis Investigative Site
Saint Ingbert - Oberwuerzbach, , Germany
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Schliemannstadt Neubukow, , Germany
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Straubing, , Germany
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Stuttgart, , Germany
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Villingen-Schwenningen, , Germany
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Wallerfing, , Germany
Novartis Investigative Site
Wangen, , Germany
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Wedemark, , Germany
Novartis Investigative Site
Weiskirchen, , Germany
Novartis Investigative Site
Wetzlar-Naunheim, , Germany
Novartis Investigative Site
Wurzen, , Germany
Novartis Investigative Site
Würzburg, , Germany
Countries
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References
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Forst T, Koch C, Dworak M. Vildagliptin versus insulin in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea: results from a randomized, 24 week study. Curr Med Res Opin. 2015 Jun;31(6):1079-84. doi: 10.1185/03007995.2015.1039936. Epub 2015 May 20.
Zuckermann A, Wang SS, Ross H, Frigerio M, Eisen HJ, Bara C, Hoefer D, Cotrufo M, Dong G, Junge G, Keogh AM. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial. J Transplant. 2011;2011:535983. doi: 10.1155/2011/535983. Epub 2011 Sep 13.
Other Identifiers
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2012-001143-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLAF237ADE08
Identifier Type: -
Identifier Source: org_study_id