Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly (ME01)

April 28, 2014 updated by: Jae Yong Chung, Seoul National University Hospital

A Phase I Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in Elderly Healthy Male Volunteers

This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males aged 65-85 years with a body mass index (BMI) of 18-28 kg/m2
  • Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations including hematology (blood cell count, hemoglobin, and platelet count), liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin), serum creatinine, blood glucose and urinalysis

Exclusion Criteria:

  • If they had clinically relevant disorders
  • Past history of diabetes or clinical findings to suspect diabetes
  • Abnormal clinical laboratory values (i.e., platelets ≤ 75,000/mm3, hemoglobin ≤ 9 g/dL, neutrophils absolute ≤ 1000/mm3, fasting glucose > 126mg/dL, creatinine ≥ 1.5 mg/dL, or AST, ALT > 3 × upper limit of normal)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Metformin 750mg(D1), Metformin 500mg(D2)
Drug: Metformin
Other Names:
  • Diabex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC(area under the plasma concentration-time curve)
Time Frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose
AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2
Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUGC(total area under the serum concentration-time curve for glucose concentration)
Time Frame: predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test
AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)
predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Yong Chung, M.D., Ph.D., Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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