Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
Brief summary
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide 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.
Interventions
DRUGvildagliptin
DRUGGliclazide
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Not currently on drug therapy for type 2 diabetes * Body mass index (BMI) in the range 22-45 * Blood glucose criteria must be met
Exclusion criteria
* Pregnancy or lactation * Type 1 diabetes * Evidence of significant diabetic complications * Evidence of serious cardiovascular conditions * Laboratory value abnormalities as defined by the protocol * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 104 weeks | 104 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event profile at 104 weeks | 104 weeks |
| Change from baseline in fasting plasma glucose at 104 weeks | 104 weeks |
| Patients with endpoint HbA1c <7% after 104 weeks | 104 weeks |
| Patients with reduction in HbA1c >/= 0.7% after 104 weeks | 104 weeks |
| Patients with reduction in HbA1x >/= 0.5% after 104 weeks | 104 weeks |
Countries
Germany, Switzerland
Outcome results
None listed