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

NCT ID: NCT01309698

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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Drug interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment Sequence 1

Group Type EXPERIMENTAL

Vildagliptin (LAF237)

Intervention Type DRUG

Voglibose

Intervention Type DRUG

Vildagliptin and Voglibose

Intervention Type DRUG

Treatment Sequence 2

Group Type EXPERIMENTAL

Vildagliptin (LAF237)

Intervention Type DRUG

Voglibose

Intervention Type DRUG

Vildagliptin and Voglibose

Intervention Type DRUG

Treatment Sequence 3

Group Type EXPERIMENTAL

Vildagliptin (LAF237)

Intervention Type DRUG

Voglibose

Intervention Type DRUG

Vildagliptin and Voglibose

Intervention Type DRUG

Treatment Sequence 4

Group Type EXPERIMENTAL

Vildagliptin (LAF237)

Intervention Type DRUG

Voglibose

Intervention Type DRUG

Vildagliptin and Voglibose

Intervention Type DRUG

Treatment Sequence 5

Group Type EXPERIMENTAL

Vildagliptin (LAF237)

Intervention Type DRUG

Voglibose

Intervention Type DRUG

Vildagliptin and Voglibose

Intervention Type DRUG

Treatment Sequence 6

Group Type EXPERIMENTAL

Vildagliptin (LAF237)

Intervention Type DRUG

Voglibose

Intervention Type DRUG

Vildagliptin and Voglibose

Intervention Type DRUG

Interventions

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Vildagliptin (LAF237)

Intervention Type DRUG

Voglibose

Intervention Type DRUG

Vildagliptin and Voglibose

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type RESULT
PMID: 23782587 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5843

Results for CLAF237A1103 from the Novartis Clinical Trials Website

Other Identifiers

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CLAF237A1103

Identifier Type: -

Identifier Source: org_study_id