Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
Brief summary
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness 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 and whose blood glucose levels are close to normal.
Interventions
DRUGvildagliptin
DRUGVildagliptin Placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Blood glucose criteria must be met * Not currently on drug therapy for type 2 diabetes * Body mass index (BMI) in the range 22-45 * Diagnosis of type 2 diabetes for at least 8 weeks
Exclusion criteria
* Pregnancy or lactation * Type 1 diabetes * Evidence of serious diabetic complications * Evidence of serious cardiovascular complications * Significant laboratory abnormalities as defined by the protocol * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event profile after 52 weeks of treatment | — |
| Patients with HbA1c <6.5% at 12 weeks | — |
| Patients with HbA1c <6.5% at 52 weeks | — |
| Change from baseline in fasting plasma glucose at 52 weeks | — |
| Coefficient of failure for HbA1c between 24 weeks and 52 weeks | — |
Countries
Germany, Switzerland
Outcome results
None listed