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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00372086




Trial ID
NCT00372086
Ethics application status
Date submitted
3/09/2006
Date registered
3/09/2006
Date last updated
3/09/2006

Titles & IDs
Public title
Rosiglitazone and Insulin in T1DM Adolescents
Scientific title
The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial
Secondary ID [1] 0 0
JHH ethics: 04/02/11/3.04
Secondary ID [2] 0 0
02/315
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Puberty: >Tanner 2 Breast Development or Testis >4ml 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone

Treatment: Drugs: Rosiglitazone


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
Secondary outcome [1] 0 0
insulin dose
Timepoint [1] 0 0
Secondary outcome [2] 0 0
frequency of severe hypoglycaemia
Timepoint [2] 0 0
Secondary outcome [3] 0 0
insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp
Timepoint [3] 0 0
Secondary outcome [4] 0 0
weight
Timepoint [4] 0 0
Secondary outcome [5] 0 0
BMI-SDS
Timepoint [5] 0 0
Secondary outcome [6] 0 0
skin fold thickness
Timepoint [6] 0 0
Secondary outcome [7] 0 0
cholesterol
Timepoint [7] 0 0
Secondary outcome [8] 0 0
adiponectin
Timepoint [8] 0 0

Eligibility
Key inclusion criteria
- T1DM duration > 1year

- age 10-18years

- HbA1c > 8%

- puberty > Tanner stage 2 breast or testis >4ml
Minimum age
10 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- known non-compliance

- hypo unaware

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2038 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sydney Children's Hospitals Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Novo Nordisk A/S
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00372086
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Monique Stone, MBBS FRACP
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries