Drug Interaction of Vildagliptin (LAF237) With Voglibose in Japanese Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01309698
First received: March 4, 2011
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
Drug: Vildagliptin (LAF237)
Drug: Voglibose
Drug: Vildagliptin and Voglibose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized and Crossover Study to Assess the Effect of Co-administration of Vildagliptin and Voglibose on the Steady-state Pharmacokinetics / Pharmacodynamics in Japanese Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pharmacokinetics of vildagliptin [ Time Frame: Up to 12 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon) [ Time Frame: Up to 4 hours or 12 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence 1 Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 2 Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 3 Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 4 Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 5 Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose
Experimental: Treatment Sequence 6 Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic patients with inadequately controlled on diet therapy and exercise therapy (HbA1c in the range 6.5 to 10.0% inclusive by NGSP)

Exclusion Criteria:

  • Fasting plasma glucose ≥ 270 mg/dL A history of Type 1 diabetes or secondary forms of diabetes Treatment of anti-diabetic agents including GLP-1 analogues within 8 weeks or insulin within 6 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309698

Locations
Japan
Novartis Investigative Site
Tokyo, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01309698     History of Changes
Other Study ID Numbers: CLAF237A1103
Study First Received: March 4, 2011
Last Updated: October 10, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
Drug interaction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Voglibose
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014