Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Results First Received: October 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 1
Interventions: Drug: insulin degludec
Drug: insulin detemir
Drug: insulin aspart

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

The trial was conducted at 72 sites in 12 countries as follows:

Bulgaria (2), Finland (5), France (4), Germany (3), Italy (2), Japan (15), Netherlands (5), Republic of Macedonia (2), Russian Federation (6), South Africa (2), United Kingdom (4), United States (22)


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IDeg + IAsp Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
IDet + IAsp Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Participant Flow for 2 periods

Period 1:   Main Trial (26 Weeks)
    IDeg + IAsp     IDet + IAsp  
STARTED     174     176 [1]
Exposed     174     175  
COMPLETED     170     165  
NOT COMPLETED     4     11  
Adverse Event                 0                 2  
Withdrawal by Subject                 4                 7  
Unclassified                 0                 2  
[1] 1 subject was randomised but withdrew before the drug exposure.

Period 2:   Extension Trial (26 Weeks)
    IDeg + IAsp     IDet + IAsp  
STARTED     152 [1]   128 [2]
COMPLETED     151     122  
NOT COMPLETED     1     6  
Adverse Event                 0                 1  
Withdrawal by Subject                 1                 5  
[1] 18 subjects did not consent to participate in the extension trial.
[2] 37 subjects did not consent to participate in the extension trial.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis set (FAS) included all randomised subjects.

Reporting Groups
  Description
IDeg + IAsp Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
IDet + IAsp Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
Total Total of all reporting groups

Baseline Measures
    IDeg + IAsp     IDet + IAsp     Total  
Number of Participants  
[units: participants]
  174     176     350  
Age  
[units: participants]
     
<=18 years     174     176     350  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     78     78     156  
Male     96     98     194  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)   [ Time Frame: Week 0, week 26 ]

2.  Secondary:   Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)   [ Time Frame: Week 0, week 52 ]

3.  Secondary:   Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)   [ Time Frame: Week 0, week 26 ]

4.  Secondary:   Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)   [ Time Frame: Week 0, week 52 ]

5.  Secondary:   Number of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: After 26 weeks and 52 weeks of treatment ]

6.  Secondary:   Number of Hypoglycaemic Episodes   [ Time Frame: After 26 weeks and 52 weeks of treatment ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


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 ( EudraCT Number )
P/44/2010 ( Other Identifier: EMA (PDCO) )
U1111-1122-4758 ( Other Identifier: WHO )
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)