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

June 3, 2019 updated by: Novo Nordisk A/S

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 3

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

  • Bulgaria
      • Sofia, Bulgaria, 1606
        • Novo Nordisk Investigational Site
      • Varna, Bulgaria, 9010
        • Novo Nordisk Investigational Site
  • Finland
      • Espoo, Finland, 02740
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70210
        • Novo Nordisk Investigational Site
      • Mikkeli, Finland, 50100
        • Novo Nordisk Investigational Site
      • OYS, Finland, 90029
        • Novo Nordisk Investigational Site
      • Pori, Finland, 28500
        • Novo Nordisk Investigational Site
  • France
      • BRON cedex, France, 69677
        • Novo Nordisk Investigational Site
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
      • Rennes, France, 35056
        • Novo Nordisk Investigational Site
      • Toulouse, France, 31059
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30173
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48155
        • Novo Nordisk Investigational Site
  • Italy
      • Chieti, Italy, 66100
        • Novo Nordisk Investigational Site
      • Genova, Italy, 16147
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00165
        • Novo Nordisk Investigational Site
  • Japan
      • Chuo-shi, Yamanashi, Japan, 409 3898
        • Novo Nordisk Investigational Site
      • Fukushima, Japan, 963-8851
        • Novo Nordisk Investigational Site
      • Iruma-gun, Saitama, Japan, 350 0495
        • Novo Nordisk Investigational Site
      • Kobe-shi, Hyogo, Japan, 657-0846
        • Novo Nordisk Investigational Site
      • Kochi-shi, Kochi, Japan, 780 0952
        • Novo Nordisk Investigational Site
      • Kumamoto-shi, Kumamoto, Japan, 860 8556
        • Novo Nordisk Investigational Site
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Novo Nordisk Investigational Site
      • Musashino-shi, Tokyo, Japan, 180 0023
        • Novo Nordisk Investigational Site
      • Niigata-shi, Niigata, Japan, 951 8520
        • Novo Nordisk Investigational Site
      • Osaka-shi, Osaka, Japan, 545 8586
        • Novo Nordisk Investigational Site
      • Sendai-shi, Miyagi, Japan, 980 8574
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 162 8666
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 157 8535
        • Novo Nordisk Investigational Site
      • Toyonaka-city, Osaka, Japan, 560 0004
        • Novo Nordisk Investigational Site
      • Tsu-shi, Mie, Japan, 514 0125
        • Novo Nordisk Investigational Site
  • Netherlands
      • Almere, Netherlands, 1315 RA
        • Novo Nordisk Investigational Site
      • Amersfoort, Netherlands, 3816 CP
        • Novo Nordisk Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • Novo Nordisk Investigational Site
      • Nijmegen, Netherlands, 6532 CL
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3011 TA
        • Novo Nordisk Investigational Site
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 125373
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119049
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630048
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191144
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410028
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410054
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZG
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B4 6NH
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • Novo Nordisk Investigational Site
      • Norwich, United Kingdom, NR4 7UY
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S102TH
        • Novo Nordisk Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Novo Nordisk Investigational Site
    • California
      • Orange, California, United States, 92868
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92123
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Novo Nordisk Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32608
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Maitland, Florida, United States, 32751
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Novo Nordisk Investigational Site
      • Baltimore, Maryland, United States, 21201
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Novo Nordisk Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Novo Nordisk Investigational Site
    • New York
      • Buffalo, New York, United States, 14203
        • Novo Nordisk Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44308
        • Novo Nordisk Investigational Site
      • Cincinnati, Ohio, United States, 45229
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78207
        • Novo Nordisk Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23235
        • 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 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin Degludec + Insulin Aspart
Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.
Experimental: Insulin Detemir +Insulin Aspart
Drug: insulin aspart
Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.
Drug: insulin detemir
Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
Time Frame: Week 0, week 26
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
Time Frame: Week 0, week 52
Change from baseline in HbA1c (%) after 52 weeks of treatments.
Week 0, week 52
Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
Time Frame: Week 0, week 26
Change from baseline in FPG after 26 weeks of treatment.
Week 0, week 26
Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
Time Frame: Week 0, week 52
Change from baseline in FPG after 52 weeks of treatment.
Week 0, week 52
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: After 26 weeks and 52 weeks of treatment
TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
After 26 weeks and 52 weeks of treatment
Number of Hypoglycaemic Episodes
Time Frame: After 26 weeks and 52 weeks of treatment
Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours)
After 26 weeks and 52 weeks of treatment
Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))
Time Frame: After 26 weeks and 52 weeks of treatment
Episodes of PG >11.1mmol/L (200mg/dL)
After 26 weeks and 52 weeks of treatment
Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))
Time Frame: After 26 weeks and 52 weeks of treatment
Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment
After 26 weeks and 52 weeks of treatment
Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
Time Frame: Between week 1 and week 26
Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.
Between week 1 and week 26
Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
Time Frame: After 52 weeks of treatment
Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)
After 52 weeks of treatment

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)

January 16, 2012

Primary Completion (Actual)

July 30, 2013

Study Completion (Actual)

July 30, 2013

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3561
  • 2011-003148-39 (EudraCT Number)
  • P/44/2010 (OTHER: EMA (PDCO))
  • U1111-1122-4758 (Other Identifier: WHO)

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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