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Completed

NCT Number: NCT01513473

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

insulin detemir

Drug

Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.

insulin aspart

Drug

Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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)

  7. 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

  8. 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.

  9. 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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: BEGIN™

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 20, 2012
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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