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OpenTrials
Completed

NCT Number: NCT01467141

Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children 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

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Berlin, Germany

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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
  • Treatment with insulin for at least 6 months prior to inclusion
  • HbA1c below or equal to 11.0 %
  • Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion

Exclusion criteria

  • The receipt of any investigational drug within one month prior to this trial
  • Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
  • Total daily insulin doses at least 1.80 IU/kg
  • Treatment with oral hypoglycaemic agents
  • Known or suspected allergy to trial product or related products

Treatment and study plan

insulin aspart

Drug

Injected s.c. (under the skin) three times a day

human insulin

Drug

Injected s.c. (under the skin) 30 minutes before the meals

isophane human insulin

Drug

May be administered s.c. (under the skin) in both treatment groups thrice daily

Primary outcomes

  1. Incidence of hypoglycaemic episodes during the treatment

    Time frame: Week 0; week 24

  2. Change in HbA1c (glycosylated haemoglobin A1c)

    Time frame: Week 0; week 24

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Week 0; week 24

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Nov 8, 2011
Registry last updated
Feb 23, 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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