Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin
NCT ID: NCT00396071
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
22 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
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
Vildagliptin 100 mg qd
vildagliptin
vildagliptin 100 mg
2
Matching placebo
Placebo
matching placebo
Interventions
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vildagliptin
vildagliptin 100 mg
Placebo
matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Agreement to maintain the same dose of metformin throughout the study
* Body mass index (BMI) in the range of 22-35 kg/m2
* HbA1c in the range of 7.0 to 9.0%
* FPG \<200 mg/dl (11.1 mmol/L)
* Agreement to maintain prior diet and exercise habits during the full course of the study
* Ability to comply with all study requirements and signed informed consent to participate in the study
Exclusion Criteria
* A history of acute metabolic diabetic complications
* Evidence of significant diabetic complications
* Insulin treatment for longer than 10 days within the past 6 months
* Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
30 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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Diabetes Zentrum Bad Lauterberg
Bad Lauterberg im Harz, , Germany
Novartis Pharmaceuticals
Basel, , Switzerland
Countries
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References
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Vardarli I, Nauck MA, Kothe LD, Deacon CF, Holst JJ, Schweizer A, Foley JE. Inhibition of DPP-4 with vildagliptin improved insulin secretion in response to oral as well as "isoglycemic" intravenous glucose without numerically changing the incretin effect in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011 Apr;96(4):945-54. doi: 10.1210/jc.2010-2178. Epub 2011 Jan 14.
Other Identifiers
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CLAF237A2387
Identifier Type: -
Identifier Source: org_study_id