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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00437970
First Posted: February 21, 2007
Last Update Posted: May 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Menzies School of Health Research
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • HbA1c values [ Time Frame: second monthly ]
  • Weight gain [ Time Frame: monthly ]
  • Weight distribution [ Time Frame: six monthly ]
  • Medication side effects [ Time Frame: monthly ]

Secondary Outcome Measures:
  • Medication compliance [ Time Frame: monthly ]
  • Side effects [ Time Frame: monthly ]
  • Lipids [ Time Frame: second monthly ]
  • Endothelial dysfunction. [ Time Frame: second monthly ]

Enrollment: 0
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: The Director, Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT00437970     History of Changes
Other Study ID Numbers: DART-MSHR-06-29
First Submitted: February 18, 2007
First Posted: February 21, 2007
Last Update Posted: May 27, 2016
Last Verified: April 2009

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