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

February 22, 2017 updated by: Novo Nordisk A/S

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

This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • 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
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: isophane human insulin
May be administered s.c. (under the skin) in both treatment groups thrice daily
Drug: human insulin
Injected s.c. (under the skin) 30 minutes before the meals

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Week 0; week 24
Week 0; week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2002

Primary Completion (Actual)

October 15, 2003

Study Completion (Actual)

October 15, 2003

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-1415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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