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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00372086
Registration number
NCT00372086
Ethics application status
Date submitted
3/09/2006
Date registered
6/09/2006
Date last updated
6/09/2006
Titles & IDs
Public title
Rosiglitazone and Insulin in T1DM Adolescents
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Scientific title
The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial
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Secondary ID [1]
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JHH ethics: 04/02/11/3.04
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Secondary ID [2]
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02/315
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes
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Puberty: >Tanner 2 Breast Development or Testis >4ml
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone
Treatment: Drugs: Rosiglitazone
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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HbA1c
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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insulin dose
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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frequency of severe hypoglycaemia
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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weight
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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BMI-SDS
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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skin fold thickness
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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cholesterol
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Assessment method [7]
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Timepoint [7]
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Secondary outcome [8]
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adiponectin
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Assessment method [8]
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Timepoint [8]
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Eligibility
Key inclusion criteria
- T1DM duration > 1year
- age 10-18years
- HbA1c > 8%
- puberty > Tanner stage 2 breast or testis >4ml
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Minimum age
10
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
- known non-compliance
- hypo unaware
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Children's Hospital - Sydney
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Recruitment postcode(s) [1]
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2038 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of New South Wales
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Sydney Children's Hospitals Network
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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National Health and Medical Research Council, Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/Industry
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Name [3]
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Novo Nordisk A/S
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need
insulin injections, blood sugar monitoring several times each day, and adhere to a strict
diet. Adequate control of blood glucose is essential to prevent long term kidney and eye
complications that result in kidney failure and blindness. Adolescence is a time when
diabetes is difficult to control, due in part to high growth hormone levels causing insulin
resistance ( a state where the body does not respond as strongly to insulin). This study will
test whether treatment with rosiglitazone (an oral medication used frequently in type 2
diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1
diabetes during puberty.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00372086
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Monique Stone, MBBS FRACP
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Address
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Royal North Shore Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00372086
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