Type 2 Diabetes Mellitus
Conditions
Brief summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
Interventions
DRUGVildagliptin
DRUGPlacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of T2DM by standard criteria. * Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides * Age: ≥18 to ≤ 80 years * HbA1c of ≥ 7.5 and ≤ 11.0% * Body Mass Index (BMI) ≥22 to ≤45 kg/m2
Exclusion criteria
* FPG ≥ 270 mg/dL (≥ 15.0 mmol/L) * Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months * Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention * History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes * Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c Reduction | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| FPG reduction | 24 weeks |
| Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs) | 24 weeks |
| Responder Rate | 24 weeks |
Countries
Australia, Germany, Hungary, Italy, Mexico, Philippines, Romania, South Korea, Taiwan
Outcome results
None listed