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
  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:


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 April 16, 2014