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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:
ClinicalTrials.gov Identifier:
NCT01513473
First Posted: January 20, 2012
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513473


  Hide Study Locations
Locations
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
Novo Nordisk Investigational Site
Orange, California, United States, 92868
Novo Nordisk Investigational Site
San Diego, California, United States, 92123
United States, Colorado
Novo Nordisk Investigational Site
Aurora, Colorado, United States, 80045
United States, Connecticut
Novo Nordisk Investigational Site
New Haven, Connecticut, United States, 06511
United States, Florida
Novo Nordisk Investigational Site
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
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40202
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21201
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02215
Novo Nordisk Investigational Site
Worcester, Massachusetts, United States, 01655
United States, New York
Novo Nordisk Investigational Site
Buffalo, New York, United States, 14222
United States, Ohio
Novo Nordisk Investigational Site
Akron, Ohio, United States, 44308
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75235
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78207
United States, Virginia
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23507
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23235
Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1606
Novo Nordisk Investigational Site
Varna, Bulgaria, 9010
Finland
Novo Nordisk Investigational Site
Espoo, Finland, 02740
Novo Nordisk Investigational Site
Kuopio, Finland, 70210
Novo Nordisk Investigational Site
Mikkeli, Finland, 50100
Novo Nordisk Investigational Site
Oulu, Finland, 90029
Novo Nordisk Investigational Site
Pori, Finland, 28500
France
Novo Nordisk Investigational Site
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
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Hannover, Germany, 30173
Novo Nordisk Investigational Site
Ludwigshafen, Germany, 67059
Novo Nordisk Investigational Site
Münster, Germany, 48155
Italy
Novo Nordisk Investigational Site
Chieti, Italy, 66100
Novo Nordisk Investigational Site
Genova, Italy, 16147
Novo Nordisk Investigational Site
Roma, Italy, 00165
Japan
Novo Nordisk Investigational Site
Chuo-shi, Yamanashi, Japan, 409 3898
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
Koriyama-shi, Fukushima, Japan, 963 8851
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, 157 8535
Novo Nordisk Investigational Site
Tokyo, Japan, 162 8666
Novo Nordisk Investigational Site
Toyonaka-city, Osaka, Japan, 560 0004
Novo Nordisk Investigational Site
Tsu-shi, Mie, Japan, 514 0125
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Netherlands
Novo Nordisk Investigational Site
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
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119049
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125373
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
South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7925
United Kingdom
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01513473     History of Changes
Other Study ID Numbers: NN1250-3561
2011-003148-39 ( EudraCT Number )
P/44/2010 ( Other Identifier: EMA (PDCO) )
U1111-1122-4758 ( Other Identifier: WHO )
First Submitted: January 16, 2012
First Posted: January 20, 2012
Results First Submitted: October 12, 2015
Results First Posted: January 12, 2016
Last Update Posted: March 3, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs


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