Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00120536
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 288
Inclusion Criteria
- Not currently on drug therapy for type 2 diabetes
- Blood glucose criteria must be met
- Body mass index (BMI) in the range 22-45
Exclusion Criteria
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Serious cardiovascular events within the past 6 months
- Laboratory value abnormalities as defined by the protocol
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at 24 weeks
- Secondary Outcome Measures
Name Time Method Adverse event profile after 24 weeks of treatment Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c Change from baseline in fasting plasma glucose at 24 weeks Patients with reduction in HbA1c >/= 0.7% after 24 weeks Patients with endpoint HbA1c < 7% after 24 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States
Novartis Pharmaceuticals🇺🇸East Hanover, New Jersey, United States