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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01513473
First received: January 16, 2012
Last updated: December 8, 2015
Last verified: December 2015
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin degludec
Drug: insulin detemir
Drug: insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c (%) after 26 weeks of treatment.


Secondary Outcome Measures:
  • Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c (%) after 52 weeks of treatments.

  • Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
    Change from baseline in FPG after 26 weeks of treatment.

  • Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
    Change from baseline in FPG after 52 weeks of treatment.

  • Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: After 26 weeks and 52 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Number of Hypoglycaemic Episodes [ Time Frame: After 26 weeks and 52 weeks of treatment ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    Episodes of PG >11.1mmol/L (200mg/dL)

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.

  • 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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 350
Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 detemir
Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01513473

  Hide Study Locations
Locations
United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72202
United States, California
Novo Nordisk Clinical Trial Call Center
Orange, California, United States, 92868
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92123
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Novo Nordisk Clinical Trial Call Center
New Haven, Connecticut, United States, 06511
United States, Florida
Novo Nordisk Clinical Trial Call Center
Gainesville, Florida, United States, 32609
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32207-8426
Novo Nordisk Clinical Trial Call Center
Maitland, Florida, United States, 32751
Novo Nordisk Clinical Trial Call Center
Melbourne, Florida, United States, 32901
Novo Nordisk Clinical Trial Call Center
Tallahassee, Florida, United States, 32308
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30318
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30322
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Lexington, Kentucky, United States, 40503
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Worcester, Massachusetts, United States, 01655
United States, New York
Novo Nordisk Clinical Trial Call Center
Buffalo, New York, United States, 14222
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75235
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23507
Bulgaria
Varna, Bulgaria, 9010
Finland
Espoo, Finland, 02740
France
Toulouse, France, 31059
Germany
Hannover, Germany, 30173
Italy
Chieti, Italy, 66100
Japan
Tokyo, Japan, 162 8666
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Netherlands
Amersfoort, Netherlands, 3816 CP
Russian Federation
Moscow, Russian Federation, 117036
South Africa
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01513473     History of Changes
Other Study ID Numbers: NN1250-3561  2011-003148-39  P/44/2010  U1111-1122-4758 
Study First Received: January 16, 2012
Results First Received: October 12, 2015
Last Updated: December 8, 2015
Health Authority: United States: Food and Drug Administration
Russia: Federal Service for Control of Health Care and Social Development
Japan: Ministry of Health, Labor and Welfare
South Africa: Medicines Control Council
Italy: The Italian Medicines Agency
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Bulgaria: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: Dutch Health Care Inspectorate
Finland: Finnish Medicines Agency Fimea
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016