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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Renal Insufficiency
• Interventions: Drug: vildagliptin; Drug: Placebo

• Registration Number: NCT00765830
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-02
• Disposition First Submitted QC: 2013-01-02
• Disposition First Posted: 2013-01-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

Inclusion Criteria

• Complete the core study

Exclusion Criteria

• Did not comply with core study requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	vildagliptin	50mg qd vildagliptin
2	Placebo	Placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency	52 weeks

Trial Locations

Locations (89)

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

Clinica Reina Fabiola; 🇦🇷 Cordoba, Argentina

Hospital Juan Ramon Vidal; 🇦🇷 Corrientes, Argentina

Hospital Zenon J. Santillan; 🇦🇷 San Miguel de Tucuman, Argentina

The Queen Elizabeth Hospital; 🇦🇺 Woodville, South Australia, Australia

Heidelberg Repatriation Hospital; 🇦🇺 Heidelberg Heights, Australia

SA Endocrine Clinical Research; 🇦🇺 Keswick, Australia

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