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OpenTrials
Completed

NCT Number: NCT00435019

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

This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin

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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

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Insulin detemir naive
  • Type 1 diabetes for at least 12 months
  • HbA1c lesser than or equal to 11.0%

Exclusion criteria

  • Significant concomitant diseases

Treatment and study plan

insulin detemir

Drug

s.c. injection, once or twice daily.

insulin NPH

Drug

s.c. injection, once or twice daily.

insulin aspart

Drug

s.c. injection, at main meals.

Primary outcomes

  1. Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: after 52 weeks of treatment

    Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.

Secondary outcomes

  1. Number of Subjects Reporting Adverse Events

    Time frame: from week -2 to week 52

    Number of subjects reporting adverse events during the trial (from week -2 to week 52).

    For details, please refer to the adverse events section.

  2. Observed Insulin Antibody Values

    Time frame: at 0 and 52 weeks

    Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 14, 2007
Registry last updated
Mar 10, 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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