Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
1/08/2003
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/study/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00372086