Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes, Vildagliptin
Brief summary
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.
Interventions
DRUGVildagliptin
DRUGPlacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years of age at Visit 1 * Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1 * HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1 * Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1
Exclusion criteria
* Pregnant or lactating female * FPG ≥ 270 mg/dL (≥15 mmol/L) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks. | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks | 24 weeks |
| Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM | 24 weeks |
| Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM | 76 weeks |
| Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM | 24 weeks |
Countries
Canada, India, Malaysia, Philippines, Puerto Rico, Romania, Slovakia, United States
Outcome results
None listed