Conditions: Type 2 Diabetes Hypoglycemia
Keywords: diabetes hypoglycemia glycemic variability vildagliptin glimepiride
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.

Detailed description:

Arms:
arm 1: Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks arm 2: Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin

Interventions: intervention 1: vildagliptin and metformin (combination) intervention 2: glimepiride intervention 3: Metformin
Intervention descriptions: intervention 1: vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid intervention 2: None intervention 3: None

Protocol document: