Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, Vildagliptin, HbA1c
Brief summary
This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.
Interventions
DRUGVildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
* Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea * Patients on diet and exercise who have not reached target blood glucose levels * Outpatients
Exclusion criteria
* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * Significant cardiovascular complications as defined by the protocol * Significant diabetic complications as defined by the protocol Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to endpoint on HbA1c at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to endpoint on fasting plasma glucose at 12 weeks | — |
| Change from baseline to endpoint in HOMA B at 12 weeks | — |
| Change from baseline to endpoint in HOMA IR at 12 weeks | — |
| Change from baseline to endpoint on fasting lipids at 12 weeks | — |
| Adverse events profile after 12 weeks of treatment | — |
Countries
Japan
Outcome results
None listed