Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
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.
Interventions
DRUGvildagliptin
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose at 24 weeks | — |
| Adverse event profile after 24 weeks of treatment | — |
| 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 | — |
Countries
Germany
Outcome results
None listed