Medication in Early Diabetes (MED) Study

NCT ID: NCT00437970

Last Updated: 2016-05-27

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Arm A- Metformin

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

500 mg of Metformin taken orally twice a day

B

Arm B- Pioglitazone

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

15mg of Pioglitazone taken orally twice a day

Interventions

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Pioglitazone

15mg of Pioglitazone taken orally twice a day

Intervention Type DRUG

Metformin

500 mg of Metformin taken orally twice a day

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Menzies School of Health Research

OTHER

Sponsor Role lead

Responsible Party

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Menzies School of Health Research

Principal Investigators

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Louise Maple Brown, MBBS PhD FRACP

Role: PRINCIPAL_INVESTIGATOR

Menzies School of Health Research

Locations

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Menzies School of Health Research

Darwin, Northern Territory, Australia

Site Status

Countries

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Australia

Related Links

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Other Identifiers

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DART-MSHR-06-29

Identifier Type: -

Identifier Source: org_study_id

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