Medication in Early Diabetes (MED) Study

May 26, 2016 updated by: Menzies School of Health Research

Drug naïve Indigenous Australians With Type 2 Diabetes, Enrolled in a Randomised Controlled Trial of Rosiglitazone Versus Metformin Monotherapy to Assess the Effects on Metabolic and Cardiovascular Parameters

This study compares metformin (current first-line medication) to pioglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of pioglitazone use in other populations, in light of the known weight gain effects of pioglitazone we believe further assessment is required in Indigenous Australians (in whom there is a strong predisposition for central fat deposition). This study will provide evidence regarding the medication appropriate for first line medication in Type 2 diabetes in this high risk population. This study will assist clinicians to make evidenced-based decisions regarding initial medical management of those with Type 2 diabetes (where there is currently a gap in evidence).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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

  • Australia
    • Northern Territory
      • Darwin, Northern Territory, Australia, 0810
        • Menzies School of Health Research

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Drug naïve Indigenous Australians with Type 2 Diabetes
  • Permanent resident of Darwin for at least 1 year immediately before and expected to be for at least 1 year after study commences
  • Participants must be able to give informed voluntary consent
  • Both males and females (females of child bearing potential excluded if not on reliable means of contraception)

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Arm A- Metformin
Drug: Metformin
500 mg of Metformin taken orally twice a day
ACTIVE_COMPARATOR: B
Arm B- Pioglitazone
Drug: Pioglitazone
15mg of Pioglitazone taken orally twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c values
Time Frame: second monthly
second monthly
Weight gain
Time Frame: monthly
monthly
Weight distribution
Time Frame: six monthly
six monthly
Medication side effects
Time Frame: monthly
monthly

Secondary Outcome Measures

Outcome Measure
Time Frame
Medication compliance
Time Frame: monthly
monthly
Side effects
Time Frame: monthly
monthly
Lipids
Time Frame: second monthly
second monthly
Endothelial dysfunction.
Time Frame: second monthly
second monthly

Collaborators and Investigators

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

Sponsor

Menzies School of Health Research

Investigators

  • Principal Investigator: Louise Maple Brown, MBBS PhD FRACP, Menzies School of Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ANTICIPATED)

February 1, 2009

Study Registration Dates

First Submitted

February 18, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (ESTIMATE)

February 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 26, 2016

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DART-MSHR-06-29

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe