Safety of Insulin Detemir in Children With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605137
• Other study ID #: NN304-1604
• Secondary ID: JapicCTI-R070014
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2008
• Last updated: February 22, 2017
• Start date: May 21, 2004
• Est. completion date: April 23, 2005

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: April 23, 2005
• Est. primary completion date: April 23, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir

• insulin NPH

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypoglycaemic episodes		during treatment
Secondary	Adverse events
Secondary	Laboratory assessments and other safety endpoints
Secondary	HbA1C, self monitored blood glucose and within-subject variability of glucose
Secondary	Height
Secondary	Insulin doses

External Links

•   Clinical Trials at Novo Nordisk