Rosiglitazone and Insulin in T1DM Adolescents

This study has been completed.

First Received: September 3, 2006 No Changes Posted

Sponsor:	The University of New South Wales
Collaborators:	Sydney Children's Hospital National Health and Medical Research Council, Australia Novo Nordisk
Information provided by:	The University of New South Wales
ClinicalTrials.gov Identifier:	NCT00372086

Purpose

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

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
BMI-SDS
skin fold thickness
cholesterol
adiponectin

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

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Both

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372086

Locations

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 Hospital

National Health and Medical Research Council, Australia

Novo Nordisk

Investigators

Principal Investigator:

Monique Stone, MBBS FRACP

Royal North Shore Hospital

More Information

No publications provided

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
ClinicalTrials.gov Identifier:	NCT00372086 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010