Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646542

CLAF237A23137

Details and patient eligibility

About

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

Enrollment: 525 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History T2DM
• Moderate or Severe Renal Impairment

Exclusion criteria

• Glucose > 270 mg/dL (>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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525 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Vildagliptin

2

Placebo Comparator group

Treatment:

Drug: Placebo