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: August 20, 2014
Last verified: August 2014

January 16, 2012
August 20, 2014
January 2012
February 2013   (final data collection date for primary outcome measure)
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 (glycosylated haemoglobin) (%) (analysed by central laboratory) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01513473 on ClinicalTrials.gov Archive Site
  • 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 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 fasting blood glucose (FPG) at 52 weeks (analysed by central laboratory) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: After 26 weeks and 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: After 26 weeks and 52 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change from baseline in fasting blood glucose (FPG) (analysed by central laboratory) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of self-measured hyperglycaemia (episodes of PG above 11.1 mmol/L (200 mg/dL)) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 of treatment ] [ 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 [ Time Frame: Between week 1 and week 26 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin degludec
    Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
  • 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.
  • Experimental: insulin degludec + insulin aspart
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin aspart
  • Active Comparator: insulin detemir + insulin aspart
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
July 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
1 Year to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Finland,   France,   Germany,   Italy,   Japan,   Macedonia, The Former Yugoslav Republic of,   Netherlands,   Russian Federation,   South Africa,   United Kingdom
 
NCT01513473
NN1250-3561, 2011-003148-39, U1111-1122-4758
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP