Phase 4 Study in the Elderly Patients With T2DM

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus (DM) patients aged 65 to 80 years, willing to perform SMBG in case of symptomatic hypoglycemia.

• HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months.

Exclusion Criteria:

• Age > 80 yrs

• BMI < 22 and ≥ 45 kg/m2

• Secondary T2 DM

• Hepatic failure, moderate/severe renal failure (Cl < 50 ml/min) and CHF III & IV

• ASAT / ALAT > 3 ULN, creatinine clearance < 50 ml/min Other protocol-defined inclusion/exclusion criteria may apply