A randomised trial of pioglitazone versus metformin monotherapy in Indigenous Australians with Type 2 Diabetes: effects on metabolic and cardiovascular parameters

Drug naïve Indigenous Australians with Type 2 Diabetes, enrolled in a randomised controlled trial of pioglitazone versus metformin monotherapy to assess the effects on metabolic and cardiovascular parameters

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000135415

Enrollment

Registered

2007-02-19

Start date

2008-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study compares metformin (current first-line medication) to rosiglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of rosiglitazone 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 appropirate 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).

Interventions

Pioglitazone 15mg taken orally (Intervention) once a day for 4weeks if tolerated increased to 15mg oral twice a day taken for 6 months by Indigenous Australians with Type 2 Diabetes

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Residential: Permanent resident of Darwin for at least 1 year immediately before and expected to be for at least 1 year after study commencesConsent: Participants must be able to give informed voluntary consent.

Exclusion criteria

Women not on a reliable means of contraceptionIndividuals who are unable to give voluntary informed consentIndividual’s permanently living outside of Darwin during the study period.

Outcome results