Medication in Early Diabetes (MED) Study

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00437970
• Other study ID #: DART-MSHR-06-29
• Status: Withdrawn
• Phase: Phase 4
• First received: February 18, 2007
• Last updated: May 26, 2016
• Start date: April 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Pioglitazone
15mg of Pioglitazone taken orally twice a day
• Metformin
500 mg of Metformin taken orally twice a day

Locations

Country	Name	City	State
Australia	Menzies School of Health Research	Darwin	Northern Territory

Sponsors (1)

Lead Sponsor	Collaborator
Menzies School of Health Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c values		second monthly	No
Primary	Weight gain		monthly	Yes
Primary	Weight distribution		six monthly	No
Primary	Medication side effects		monthly	Yes
Secondary	Medication compliance		monthly	No
Secondary	Side effects		monthly	Yes
Secondary	Lipids		second monthly	No
Secondary	Endothelial dysfunction.		second monthly	No

External Links

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