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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467141
First Posted: November 8, 2011
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin aspart Drug: human insulin Drug: isophane human insulin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of hypoglycaemic episodes during the treatment [ Time Frame: Week 0; week 24 ]
  • Change in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 0; week 24 ]

Secondary Outcome Measures:
  • Incidence of Adverse Events (AEs) [ Time Frame: Week 0; week 24 ]

Enrollment: 26
Actual Study Start Date: June 19, 2002
Study Completion Date: October 15, 2003
Primary Completion Date: October 15, 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IAsp Drug: insulin aspart
Injected s.c. (under the skin) three times a day
Drug: isophane human insulin
May be administered s.c. (under the skin) in both treatment groups thrice daily
Active Comparator: HI Drug: human insulin
Injected s.c. (under the skin) 30 minutes before the meals
Drug: isophane human insulin
May be administered s.c. (under the skin) in both treatment groups thrice daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467141


Locations
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Dresden, Germany, 01307
Novo Nordisk Investigational Site
Hagen, Germany, 58095
Novo Nordisk Investigational Site
Hamburg, Germany, 22149
Novo Nordisk Investigational Site
Hannover, Germany, 30173
Novo Nordisk Investigational Site
Osnabrück, Germany, 49082
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467141     History of Changes
Other Study ID Numbers: ANA-1415
First Submitted: November 4, 2011
First Posted: November 8, 2011
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs