Status:
COMPLETED
Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-65 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00380445
Start Date
January 1 2006
End Date
April 1 2007
Last Update
February 23 2017
Active Locations (2)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
2
Novartis Investigative Site
Investigative Centers, Germany