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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00765830

First received: October 2, 2008

Last updated: January 2, 2013

Last verified: January 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Renal Insufficiency	Drug: vildagliptin Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	349
Study Start Date:	September 2008
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 50mg qd vildagliptin	Drug: vildagliptin 50mg qd
Placebo Comparator: 2 Placebo	Drug: Placebo qd

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Complete the core study

Exclusion Criteria:

Did not comply with core study requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765830

Show 90 Study Locations

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00765830 History of Changes
Other Study ID Numbers:	CLAF237A23137E1
Study First Received:	October 2, 2008
Last Updated:	January 2, 2013
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Costa Rica: Ministry of Health Costa Rica Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices India: Drugs Controller General of India Norway: Norwegian Medicines Agency Russia: Ministry of Health of the Russian Federation Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes, vildagliptin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013

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