Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

Novartis

Status and phase: Completed; Phase 3

Conditions: Renal Insufficiency; Diabetes Mellitus, Type 2

Treatments: Drug: vildagliptin; Drug: sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770081

CLAF237A23138E1

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 52 weeks.

Enrollment: 75 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Complete the core study and consent for extension

Exclusion criteria

• Patient unable to comply with core study requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 2 patient groups

1

Experimental group

Description:

50mg qd vildagliptin

Treatment:

Drug: vildagliptin

2

Active Comparator group

Description:

sitagliptin (25mg qd)

Treatment:

Drug: sitagliptin