Status:
COMPLETED
Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-78 years
Phase:
PHASE3
Brief Summary
This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
- 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
- A history of type 1 diabetes
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00396071
Start Date
October 1 2006
Last Update
November 18 2016
Active Locations (2)
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1
Diabetes Zentrum Bad Lauterberg
Bad Lauterberg im Harz, Germany, 37431
2
Novartis Pharmaceuticals
Basel, Switzerland