Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
Brief summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
Interventions
DRUGvildagliptin
DRUGglimepiride
DRUGMetformin
DRUGVildagliptin matching placebo
DRUGGlimepiride matching placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 73 Years
Healthy volunteers
No
Inclusion criteria
* On a stable dose of metformin as defined by the protocol * 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 complications * Laboratory value abnormalities as defined by the protocol * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to HbA1c >8% | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 5 years | 2 years (amended) |
| Adverse event profile after 5 years of treatment | 2 years (amended) |
| Coefficient of failure for HbA1c from week 24 to 5 years | 2 years (amended) |
| Change from baseline in fasting plasma glucose at 5 years | 2 years (amended) |
| Change from baseline in body weight at 5 years | 2 years (amended) |
Countries
Germany, United States
Outcome results
None listed