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A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus | Clinical Trials | Clareo Health

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A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)

NCT01513473•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

Eligibility

Age

1 - 17 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements
•Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
•Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
•HbA1c (glycosylated haemoglobin) maximum 11%

Exclusion Criteria

•Known or suspected hypersensitivity to trial product(s) or related products
•Previous participation in this trial. Participation is defined as randomisation
•Girls who are pregnant, breastfeeding or intend to become pregnant
•Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
•Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
•More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
•Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
•The receipt of any investigational drug within 1 month prior to Visit 1

Locations (81)

Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

Novo Nordisk Investigational Site

Orange, California, United States

Novo Nordisk Investigational Site

San Diego, California, United States

Novo Nordisk Investigational Site

Aurora, Colorado, United States

Novo Nordisk Investigational Site

New Haven, Connecticut, United States

Novo Nordisk Investigational Site

Gainesville, Florida, United States

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Novo Nordisk Investigational Site

Maitland, Florida, United States

Novo Nordisk Investigational Site

Melbourne, Florida, United States

Novo Nordisk Investigational Site

Tallahassee, Florida, United States

Key Dates

Start Date

January 16, 2012

Primary Completion Date

July 30, 2013

Completion Date

July 30, 2013

Last Updated

June 13, 2019

Enrollment

350

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 1

Interventions

insulin degludec

DRUG

insulin detemir

DRUG

insulin aspart

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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