Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

Novartis

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Vildagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257451

CLAF237A23150

2010-022658-18

Details and patient eligibility

About

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).

Enrollment: 431 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age: ≥ 70 years inclusive at Visit 1.
• patients with a confirmed diagnosis of T2DM
• HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
• body mass index (BMI) in the range of 19-45kg/m2

Exclusion criteria

• FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
• previous or current participation in any vildagliptin clinical study.
• history of hypersensitivity to DPP-4 inhibitors.
• concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
• donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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431 participants in 2 patient groups, including a placebo group

Vildagliptin

Experimental group

Treatment:

Drug: Vildagliptin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo