Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, vildagliptin
Brief summary
This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. The purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.
Interventions
DRUGvildagliptin
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Only patients successfully completing study CLAF237A2329 are eligible * Written informed consent * HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units * Ability to comply with all study requirements
Exclusion criteria
* Premature discontinuation from study CLAF237A2329 * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety in combination with pioglitizone after 52 weeks of treatment | — |
| Change from baseline in HbA1c at 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in body weight at 52 weeks | — |
| Change from baseline in fasting plasma glucose at 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 lipids at 52 weeks | — |
Countries
Switzerland
Outcome results
None listed