NCT01309698

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

December 19, 2020

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

March 4, 2011

Last Update Submit

December 16, 2020

Conditions

Type 2 Diabetes

Keywords

Drug interaction

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of vildagliptin

    Up to 12 hours post-dose

Secondary Outcomes (1)

  • Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon)

    Up to 4 hours or 12 hours post-dose

Study Arms (6)

Treatment Sequence 1

EXPERIMENTAL
Drug: Vildagliptin (LAF237)Drug: VogliboseDrug: Vildagliptin and Voglibose

Treatment Sequence 2

EXPERIMENTAL
Drug: Vildagliptin (LAF237)Drug: VogliboseDrug: Vildagliptin and Voglibose

Treatment Sequence 3

EXPERIMENTAL
Drug: Vildagliptin (LAF237)Drug: VogliboseDrug: Vildagliptin and Voglibose

Treatment Sequence 4

EXPERIMENTAL
Drug: Vildagliptin (LAF237)Drug: VogliboseDrug: Vildagliptin and Voglibose

Treatment Sequence 5

EXPERIMENTAL
Drug: Vildagliptin (LAF237)Drug: VogliboseDrug: Vildagliptin and Voglibose

Treatment Sequence 6

EXPERIMENTAL
Drug: Vildagliptin (LAF237)Drug: VogliboseDrug: Vildagliptin and Voglibose

Interventions

Vildagliptin (LAF237)DRUG
Treatment Sequence 1Treatment Sequence 2Treatment Sequence 3Treatment Sequence 4Treatment Sequence 5Treatment Sequence 6
VogliboseDRUG
Treatment Sequence 1Treatment Sequence 2Treatment Sequence 3Treatment Sequence 4Treatment Sequence 5Treatment Sequence 6
Vildagliptin and VogliboseDRUG
Treatment Sequence 1Treatment Sequence 2Treatment Sequence 3Treatment Sequence 4Treatment Sequence 5Treatment Sequence 6

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23782587RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidinevoglibose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 7, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Last Updated

December 19, 2020

Record last verified: 2016-11

Locations

JP(1)