Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
Brief summary
This is a 28-week extension to a study of the 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 been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather long-term safety and efficacy data for vildagliptin in people with type 2 diabetes.
Interventions
DRUGvildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
* Only patients successfully completing study CLAF237A2301 are eligible * Written informed consent * Ability to comply with all study requirements
Exclusion criteria
* Premature discontinuation from study CLAF237A2301 * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of vildagliptin during 52 weeks of treatment | — |
| Change from baseline in HbA1c at 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting plasma glucose between 24 weeks and 52 weeks | — |
| Change in HbA1c between 24 weeks and 52 weeks | — |
| Change from baseline in HOMA IR at 52 weeks | — |
| Change from baseline in HOMA B at 52 weeks | — |
| Change from baseline in fasting plasma glucose at 52 weeks | — |
Countries
United States
Outcome results
None listed