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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00765830

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 III

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
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

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 ]

Estimated Enrollment:	292
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLAF237A23137E1
Study First Received:	October 2, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00765830
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: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; India: Drugs Controller General of India; Norway: Norwegian Medicines Agency; Russia: Ministry of Health and Social Development 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

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Kidney Diseases
Metabolic disorder
Glucose Metabolism Disorders
Vildagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009