Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes
Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes
1 other identifier
interventional
21
2 countries
2
Brief Summary
Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Jan 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 22, 2006
CompletedFirst Posted
Study publicly available on registry
September 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFebruary 23, 2017
February 1, 2017
1.2 years
September 22, 2006
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes
Secondary Outcomes (1)
To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle)
Interventions
Eligibility Criteria
You may qualify if:
- Must be able to complete a 3-week wash-out of current anti-diabetic medication
- Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
- Must discontinue beta-blockers and lipid lowering drugs
- Blood glucose criteria must be met
- BMI in the range 30-35
You may not qualify if:
- History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Need for insulin within 3 months or patients on thiazolidinediones
- Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study
- Significant concomitant disease or complications of diabetes
- Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
- High tryglycerides as defined by the protocol
- Smokers who cannot abstain from smoking during the treatment periods
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (2)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Novartis Investigative Site
Investigative Centers, Germany
Related Publications (1)
Boschmann M, Engeli S, Dobberstein K, Budziarek P, Strauss A, Boehnke J, Sweep FC, Luft FC, He Y, Foley JE, Jordan J. Dipeptidyl-peptidase-IV inhibition augments postprandial lipid mobilization and oxidation in type 2 diabetic patients. J Clin Endocrinol Metab. 2009 Mar;94(3):846-52. doi: 10.1210/jc.2008-1400. Epub 2008 Dec 16.
PMID: 19088168RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2006
First Posted
September 26, 2006
Study Start
January 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
February 23, 2017
Record last verified: 2017-02