Medication in Early Diabetes (MED) Study

Menzies School of Health Research

Status and phase

Withdrawn

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Pioglitazone

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT00437970

DART-MSHR-06-29

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)