Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00099931
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
Inclusion Criteria
- Blood glucose criteria must be met
- On a stable dose of insulin as defined by the protocol
- Body mass inde (BMI) in the range 22-45
Exclusion Criteria
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular complications
- 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 fasting plasma glucose at 24 weeks Change from baseline in mean daily insulin dose at 24 weeks Change from baseline in mean daily number of insulin injections at 24 weeks Patients with endpoint <7% after 24 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Investigative Sites, Germany