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Rosiglitazone and Insulin in T1DM Adolescents

This study has been completed.
Sydney Children's Network
National Health and Medical Research Council, Australia
Novo Nordisk A/S
Information provided by:
The University of New South Wales Identifier:
First received: September 3, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
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.

Condition Intervention Phase
Type 1 Diabetes Puberty: >Tanner 2 Breast Development or Testis >4ml Drug: Rosiglitazone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial

Resource links provided by NLM:

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • HbA1c

Secondary Outcome Measures:
  • insulin dose
  • frequency of severe hypoglycaemia
  • insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp
  • weight
  • skin fold thickness
  • cholesterol
  • adiponectin

Estimated Enrollment: 32
Study Start Date: August 2003
Estimated Study Completion Date: September 2005

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00372086

Australia, New South Wales
Sydney Children's Hospital
Sydney, New South Wales, Australia, 2038
Sponsors and Collaborators
The University of New South Wales
Sydney Children's Network
National Health and Medical Research Council, Australia
Novo Nordisk A/S
Principal Investigator: Monique Stone, MBBS FRACP Royal North Shore Hospital
  More Information Identifier: NCT00372086     History of Changes
Other Study ID Numbers: 02/315
JHH ethics: 04/02/11/3.04
CHW ethics: 2003/037
Study First Received: September 3, 2006
Last Updated: September 3, 2006

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 19, 2017