Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes mellitus, vildagliptin
Brief summary
The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in the treatment of type 2 diabetes.
Interventions
DRUGvildagliptin
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of T2DM by standard criteria 2. Patients who have received a stable dose of SU for at least 12 weeks prior to Visit 1 3. HbA1c ≥7.5% to ≤ 11.0% at Visit 1 and Visit 3 (Week -1) 4. Age: ≥18 to ≤ 80 years at Visit 1. 5. BMI ≥ 20 and ≤ 40 kg/m\^2 at visit 1.
Exclusion criteria
1. FPG ≥ 270mg/dl (15.0 mmol/L) at Visit 1 or Visit 3 (Week -1) 2. Severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between Visit 2 and Visit 4) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Fasting Plasma Glucose | 24 weeks |
| Safety and tolerability (Frequency of adverse events, serious adverse events, and notable laboratory abnormalities) of add-on therapy with vildagliptin 50 mg qd to glimepiride as compared to pbo | 24 weeks |
| Responder rates - proportion of subjects reaching predefined HbA1c targets | 24 weeks |
Countries
China
Outcome results
None listed