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OpenTrials
Completed

NCT Number: NCT00571935

Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age 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

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Bialystok, Poland

Loading trial locations.

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 1 year
  • HbA1c below 12.0%
  • Treatment with regular human insulin and insulin NPH for at least 1 month
  • Receive more than 2 injections daily

Exclusion criteria

  • Receipt of investigational product within 6 months prior to trial participation
  • Known or suspected allergy to investigational product
  • Receipt of of insulin aspart within 3 months prior to trial participation

Treatment and study plan

insulin aspart

Drug

soluble human insulin

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks of treatment

Secondary outcomes

  1. Overall glycaemic control

  2. Occurrence of adverse events

  3. Occurrence of serious adverse events

  4. Frequency of hypoglycaemia episodes

  5. Quality of Life (QoL)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes Mellitus

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 12, 2007
Registry last updated
Dec 21, 2016

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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