Safety of Insulin Detemir in Children With Type 1 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00605137

Purpose

This trial is conducted in Japan.

The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin detemir Drug: insulin NPH	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin Detemir Insulin, isophane

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of hypoglycaemic episodes [ Time Frame: during treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Designated as safety issue: No ]
Laboratory assessments and other safety endpoints [ Designated as safety issue: No ]
HbA1C, self monitored blood glucose and within-subject variability of glucose [ Designated as safety issue: No ]
Height [ Designated as safety issue: No ]
Insulin doses [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	May 2004

Eligibility

Criteria

Inclusion Criteria:

Type 1 diabetes for at least one year
Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
HbA1C below 11.0%
Willing to comply with Investigator's instructions
Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia

Exclusion Criteria:

Impaired renal function
Impaired hepatic function
Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator)
Proliferative retinopathy or maculopathy requiring acute treatment
Uncontrolled treated/untreated hypertension
Current treatment with total daily insulin dose of more than 2.00 IU/kg
Current treatment or expected at the screening to start treatment with systemic corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605137

Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Hiroko Terano	Novo Nordisk Pharma Ltd.
Study Director:	Muneharu Kagawa	Novo Nordisk Pharma Ltd.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1604, JAPIC: JapicCTI-R070014
Study First Received:	January 17, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00605137
Health Authority:	Japan: Ministry of Health, Labour and Welfare (MHLW)

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009