Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

NCT ID: NCT00566865

Last Updated: 2009-02-18

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

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2007-12-31

Brief Summary

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The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

mitiglinide + gemfibrozil

Group Type EXPERIMENTAL

gemfibrozil

Intervention Type DRUG

Mitiglinide + 600 mg gemfibrozil bid

1

mitiglinide + placebo for gemfibrozil

Group Type PLACEBO_COMPARATOR

placebo for gemfibrozil

Intervention Type DRUG

mitiglinide + placebo for gemfibrozil 600 mg bid

Interventions

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placebo for gemfibrozil

mitiglinide + placebo for gemfibrozil 600 mg bid

Intervention Type DRUG

gemfibrozil

Mitiglinide + 600 mg gemfibrozil bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* non-smoker
* Body mass index (BMI) of 19-28 kg/m2
* no relevant food allergies

Exclusion Criteria

* any subject for whom gemfibrozil is contraindicated
* any subject with a history of hypoglycemia or who tend to get easily hypoglycemic
* clinically significant history of or current abnormality or disease of any organ system
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elixir Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Elixir Pharmaceuticals

Principal Investigators

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Erin Nulf, RN, BSN

Role: STUDY_DIRECTOR

Quintiles Phase I Services

Other Identifiers

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EX-1510-CT-002

Identifier Type: -

Identifier Source: org_study_id

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