Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: vildagliptin; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616811

CLAF237A23138

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)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.

Enrollment: 148 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• History T2 DM
• Severe Renal Impairment

Exclusion criteria

• Glucose ≥ 270 mg/dL (≥15 mmol/L)
• Patients undergoing any method of dialysis
• Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups

Vildagliptin

Experimental group

Treatment:

Drug: vildagliptin

Sitagliptin

Active Comparator group

Treatment:

Drug: Sitagliptin