Rosiglitazone and Insulin in T1DM Adolescents

Type 1 Diabetes Clinical Trial

Official title:

The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372086
• Other study ID #: 02/315
• Secondary ID: JHH ethics: 04/0
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2006
• Last updated: September 3, 2006
• Start date: August 2003
• Est. completion date: September 2005

Study information

• Verified date: September 2006
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2005
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• T1DM duration > 1year

• age 10-18years

• HbA1c > 8%

• puberty > Tanner stage 2 breast or testis >4ml

Exclusion Criteria:

• known non-compliance

• hypo unaware

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Puberty: >Tanner 2 Breast Development or Testis >4ml
• Type 1 Diabetes

Intervention

Drug:
• Rosiglitazone

Locations

Country	Name	City	State
Australia	Sydney Children's Hospital	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
The University of New South Wales	National Health and Medical Research Council, Australia, Novo Nordisk A/S, Sydney Children's Hospital, Randwick

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c
Secondary	insulin dose
Secondary	frequency of severe hypoglycaemia
Secondary	insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp
Secondary	weight
Secondary	BMI-SDS
Secondary	skin fold thickness
Secondary	cholesterol
Secondary	adiponectin