Status:
COMPLETED
Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).
Eligibility Criteria
Inclusion
- Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for \> 3 consecutive months
- \>/= 18 years
- Body mass index in the range of 22-35 kg/m2
- HbA1c \</=7.5%
Exclusion
- Type 1 diabetes
- Acute metabolic diabetic complications
- Evidence of significant diabetic complications
- Insulin treatment within the past 6 months
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00390520
Start Date
September 1 2006
End Date
September 1 2007
Last Update
February 11 2020
Active Locations (1)
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1
Novartis
Basel, Switzerland