Phase 4 Study in the Elderly Patients With T2DM (GLYCEMIA)

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus; Elderly

Treatments: Drug: Vildagliptin; Drug: "Usual Care"

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238978

CLAF237AFR03

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Vildagliptin

Experimental group

Treatment:

Drug: Vildagliptin

other Oral Antidiabetic Drug in a different therapeutic class

Active Comparator group

Treatment:

Drug: "Usual Care"