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 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients 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
20 Years to No maximum
Inclusion criteria
* Diagnosis of type 2 diabetes * Patients who have been placed on diet and exercise therapy without achieving 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 |
|---|---|
| Adverse events profile after 52 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to endpoint on HbA1c at 52 weeks | — |
| Change from baseline to endpoint on fasting plasma glucose at 52 weeks | — |
| Change from baseline to endpoint in HOMA B at 52 weeks | — |
| Change from baseline to endpoint in HOMA IR at 52 weeks | — |
| Change from baseline to endpoint in body weight at 52 weeks | — |
Countries
Japan
Outcome results
None listed