Skip to main content
OpenTrials
Completed

NCT Number: NCT00605137

Safety of Insulin Detemir in Children With Type 1 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

insulin NPH

Drug

Primary outcomes

  1. Incidence of hypoglycaemic episodes

    Time frame: during treatment

Secondary outcomes

  1. Adverse events

  2. Laboratory assessments and other safety endpoints

  3. HbA1C, self monitored blood glucose and within-subject variability of glucose

  4. Height

  5. Insulin doses

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 30, 2008
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.