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OpenTrials
Completed

NCT Number: NCT00312156

Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.

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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

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Bree, Belgium

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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 12 months
  • Informed consent obtained
  • BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2.
  • HbA1c equal to or less than 12.0%

Exclusion criteria

  • Proliferate retinopathy or maculopathy
  • Total daily insulin dose greater than 2.00 IU/kg
  • Any condition or disease that rule out trial participation according to the judgement of the investigator.
  • Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
  • A life-style incompatible with trial participation

Treatment and study plan

insulin detemir

Drug

insulin NPH

Drug

insulin aspart

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks

Secondary outcomes

  1. Adverse events

  2. body weight

  3. Antibodies

  4. Blood glucose

  5. Hypoglycaemia

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Apr 7, 2006
Registry last updated
Jan 27, 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.

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