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Safety of Insulin Detemir in Children With Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605137
First Posted: January 30, 2008
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin NPH Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of hypoglycaemic episodes [ Time Frame: during treatment ]

Secondary Outcome Measures:
  • Adverse events
  • Laboratory assessments and other safety endpoints
  • HbA1C, self monitored blood glucose and within-subject variability of glucose
  • Height
  • Insulin doses

Enrollment: 83
Actual Study Start Date: May 21, 2004
Study Completion Date: April 23, 2005
Primary Completion Date: April 23, 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605137


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00605137     History of Changes
Other Study ID Numbers: NN304-1604
JapicCTI-R070014 ( Registry Identifier: japic )
First Submitted: January 17, 2008
First Posted: January 30, 2008
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs