Safety of Insulin Detemir in Children With Type 1 Diabetes

NCT00605137 | Completed Phase 3

• 2 other identifiers: NN304-1604JapicCTI-R070014
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoglycaemic episodes

  during treatment

Secondary Outcomes (5)

• Adverse events

• Laboratory assessments and other safety endpoints

• HbA1C, self monitored blood glucose and within-subject variability of glucose

• Height

• Insulin doses

Interventions

insulin detemir DRUG

insulin NPH DRUG

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Detemir; Insulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: May 21, 2004
• Primary Completion: April 23, 2005
• Study Completion: April 23, 2005
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

JP (1)