Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437970
Status:
WITHDRAWN
Last Update Posted:
2016-05-27
First Post:
2007-02-18
Brief Title:
Medication in Early Diabetes MED Study
Sponsor:
Menzies School of Health Research
Organization:
Menzies School of Health Research
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to secure supply of the study medication
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None