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Clinical Trials/NCT00605137
NCT00605137CompletedPhase 3

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

Novo Nordisk A/S2 sites in 1 country83 target enrollmentStarted: May 21, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
83
Locations
2
Primary Endpoint
Incidence of hypoglycaemic episodes
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of hypoglycaemic episodes

Time Frame: during treatment

Secondary Outcomes

  • Laboratory assessments and other safety endpoints
  • HbA1C, self monitored blood glucose and within-subject variability of glucose
  • Height
  • Insulin doses
  • Adverse events

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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