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

Novartis349 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

349

Conditions

Diabetes Mellitus, Type 2 Renal Insufficiency

Interventions

vildagliptinDRUG

50mg qd

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Complete the core study Exclusion Criteria: * Did not comply with core study requirements

Locations (90)

Outcomes

Primary Outcomes

To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment

Time frame: 52 weeks

Secondary Outcomes

To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency

Time frame: 52 weeks

Data from ClinicalTrials.gov

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Clinica de Fracturas y Ortopedia

Buenos Aires, Argentina

Hospital Teodoro Alvarez

Buenos Aires, Argentina

Instituto de Investigaciones Clinicas de Mar del Plata

Buenos Aires, Argentina

Instituto Medico Especializado IME

Buenos Aires, Argentina

Hospital Juan Ramon Vidal

Corrientes, Argentina

Clinica Reina Fabiola

Córdoba, Argentina

Hospital Zenon J. Santillan

San Miguel de Tucumán, Argentina

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Heidelberg Repatriation Hospital

Heidelberg Heights, Australia

SA Endocrine Clinical Research

Keswick, Australia

...and 80 more locations