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

Safety of Insulin Detemir in Children With Type 1 Diabetes

Sponsors

Lead sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date May 21, 2004
Completion Date April 23, 2005
Primary Completion Date April 23, 2005
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of hypoglycaemic episodes during treatment
Secondary Outcome
Measure Time Frame
Adverse events
Laboratory assessments and other safety endpoints
HbA1C, self monitored blood glucose and within-subject variability of glucose
Height
Insulin doses
Enrollment 83
Condition
Intervention

Intervention type: Drug

Intervention name: insulin detemir

Intervention type: Drug

Intervention name: insulin NPH

Eligibility

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

Gender: All

Minimum age: 7 Years

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
facility Novo Nordisk Investigational Site
Location Countries

Japan

Verification Date

February 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov