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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01467141
First received: November 4, 2011
Last updated: January 25, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Adverse Events (AEs) [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: June 2002
Study Completion Date: October 2003
Primary Completion Date: October 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

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467141

Locations
Germany
Hamburg, Germany, 22149
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Vibeke Weinreich Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467141     History of Changes
Other Study ID Numbers: ANA-1415
Study First Received: November 4, 2011
Last Updated: January 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Isophane insulin, beef
Insulin
Insulin, Isophane
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014