NCT00437970

Medication in Early Diabetes (MED) Study

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Pioglitazone	15mg of Pioglitazone taken orally twice a day
DRUG	Metformin	500 mg of Metformin taken orally twice a day

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2007-02-21
• Last updated: 2016-05-27

Locations

1 site across 1 country: Australia