NCT00566865

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_1 type-2-diabetes-mellitus

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

1 month

First QC Date

December 3, 2007

Last Update Submit

February 16, 2009

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • pharmacokinetics of mitiglinide

    3 days of treatment with gemfibrozil

  • pharmacodynamics of mitiglinide

    3 days of treatment with gemfibrozil

Secondary Outcomes (1)

  • safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil

    3 days of treatment with gemfibrozil

Study Arms (2)

2

EXPERIMENTAL

mitiglinide + gemfibrozil

Drug: gemfibrozil

1

PLACEBO COMPARATOR

mitiglinide + placebo for gemfibrozil

Drug: placebo for gemfibrozil

Interventions

placebo for gemfibrozilDRUG

mitiglinide + placebo for gemfibrozil 600 mg bid

1
gemfibrozilDRUG

Mitiglinide + 600 mg gemfibrozil bid

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Gemfibrozil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPentanoic AcidsValeratesPhenyl EthersEthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Erin Nulf, RN, BSN

    Quintiles Phase I Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 4, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 18, 2009

Record last verified: 2009-02