Safety of Insulin Detemir in Children With Type 1 Diabetes

• Status: Completed
• Trial end date: 2005-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

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