Safety of Insulin Detemir in Children With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00605137
First received: January 17, 2008
Last updated: June 19, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: Yes ]
  • 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 ]

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

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605137

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Hiroko Terano Novo Nordisk Pharma Ltd.
Study Director: Muneharu Kagawa Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00605137     History of Changes
Other Study ID Numbers: NN304-1604, JapicCTI-R070014
Study First Received: January 17, 2008
Last Updated: June 19, 2012
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014