Safety of Insulin Detemir in Children With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin NPH; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605137

NN304-1604

JapicCTI-R070014 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)