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Medication in Early Diabetes (MED) Study

This study has been withdrawn prior to enrollment.
(Unable to secure supply of the study medication)
Sponsor:
Information provided by:
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT00437970
First received: February 18, 2007
Last updated: April 26, 2009
Last verified: April 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Pioglitazone
Drug: Metformin
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:
  • HbA1c values [ Time Frame: second monthly ] [ Designated as safety issue: No ]
  • Weight gain [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • Weight distribution [ Time Frame: six monthly ] [ Designated as safety issue: No ]
  • Medication side effects [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Medication compliance [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • Lipids [ Time Frame: second monthly ] [ Designated as safety issue: No ]
  • Endothelial dysfunction. [ Time Frame: second monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Arm A- Metformin
 Drug: Metformin
500 mg of Metformin taken orally twice a day
Active Comparator: B
Arm B- Pioglitazone
 Drug: Pioglitazone
15mg of Pioglitazone taken orally twice a day

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437970

Locations
Australia, Northern Territory
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0810
Sponsors and Collaborators
Menzies School of Health Research
Investigators
Principal Investigator: Louise Maple Brown, MBBS PhD FRACP Menzies School of Health Research
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: The Director, Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT00437970     History of Changes
Other Study ID Numbers: DART-MSHR-06-29
Study First Received: February 18, 2007
Last Updated: April 26, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013