Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)

Novartis

Status and phase: Completed; Phase 3

Conditions: Renal Insufficiency; Diabetes Mellitus, Type 2

Treatments: Drug: vildagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00765830

CLAF237A23137E1

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: 349 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Complete the core study

Exclusion criteria

• Did not comply with core study requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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349 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

50mg qd vildagliptin

Treatment:

Drug: vildagliptin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo