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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 )
March 4, 2011
March 7, 2011
November 18, 2016
February 2011
April 2011   (Final data collection date for primary outcome measure)
Pharmacokinetics of vildagliptin [ Time Frame: Up to 12 hours post-dose ]
Same as current
Complete list of historical versions of study NCT01309698 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Drug Interaction of Vildagliptin (LAF237) With Voglibose in Japanese Patients With Type 2 Diabetes
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
This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Type 2 Diabetes
  • Drug: Vildagliptin (LAF237)
  • Drug: Voglibose
  • Drug: Vildagliptin and Voglibose
  • Experimental: Treatment Sequence 1
    Interventions:
    • Drug: Vildagliptin (LAF237)
    • Drug: Voglibose
    • Drug: Vildagliptin and Voglibose
  • Experimental: Treatment Sequence 2
    Interventions:
    • Drug: Vildagliptin (LAF237)
    • Drug: Voglibose
    • Drug: Vildagliptin and Voglibose
  • Experimental: Treatment Sequence 3
    Interventions:
    • Drug: Vildagliptin (LAF237)
    • Drug: Voglibose
    • Drug: Vildagliptin and Voglibose
  • Experimental: Treatment Sequence 4
    Interventions:
    • Drug: Vildagliptin (LAF237)
    • Drug: Voglibose
    • Drug: Vildagliptin and Voglibose
  • Experimental: Treatment Sequence 5
    Interventions:
    • Drug: Vildagliptin (LAF237)
    • Drug: Voglibose
    • Drug: Vildagliptin and Voglibose
  • Experimental: Treatment Sequence 6
    Interventions:
    • Drug: Vildagliptin (LAF237)
    • Drug: Voglibose
    • Drug: Vildagliptin and Voglibose
Yamaguchi M, Saji T, Mita S, Kulmatycki K, He YL, Furihata K, Sekiguchi K. Pharmacokinetic and pharmacodynamic interaction of vildagliptin and voglibose in Japanese patients with Type 2 diabetes. Int J Clin Pharmacol Ther. 2013 Aug;51(8):641-51. doi: 10.5414/CP201902.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01309698
CLAF237A1103
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP