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Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

This study has been completed.
Information provided by:
Elixir Pharmaceuticals Identifier:
First received: December 3, 2007
Last updated: February 16, 2009
Last verified: February 2009
The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: placebo for gemfibrozil Drug: gemfibrozil Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Elixir Pharmaceuticals:

Primary Outcome Measures:
  • pharmacokinetics of mitiglinide [ Time Frame: 3 days of treatment with gemfibrozil ]
  • pharmacodynamics of mitiglinide [ Time Frame: 3 days of treatment with gemfibrozil ]

Secondary Outcome Measures:
  • safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil [ Time Frame: 3 days of treatment with gemfibrozil ]

Enrollment: 14
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
mitiglinide + gemfibrozil
Drug: gemfibrozil
Mitiglinide + 600 mg gemfibrozil bid
Placebo Comparator: 1
mitiglinide + placebo for gemfibrozil
Drug: placebo for gemfibrozil
mitiglinide + placebo for gemfibrozil 600 mg bid


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00566865

Sponsors and Collaborators
Elixir Pharmaceuticals
Study Director: Erin Nulf, RN, BSN Quintiles Phase I Services
  More Information

Responsible Party: Paul Martha, Chief Medial Officer, Elixir Pharmaceuticals Identifier: NCT00566865     History of Changes
Other Study ID Numbers: EX-1510-CT-002
Study First Received: December 3, 2007
Last Updated: February 16, 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on July 19, 2017