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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309698
First Posted: March 7, 2011
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: None (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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Pharmacokinetics of vildagliptin [ Time Frame: Up to 12 hours post-dose ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309698


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

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01309698     History of Changes
Other Study ID Numbers: CLAF237A1103
First Submitted: March 4, 2011
First Posted: March 7, 2011
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Drug interaction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Voglibose
Inositol
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances