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

Diabetes Clinical Trial

— BEGIN™  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513473
• Other study ID #: NN1250-3561
• Secondary ID: 2011-003148-39P/
• Status: Completed
• Phase: Phase 3
• Start date: January 16, 2012
• Est. completion date: July 30, 2013

Study information

• Verified date: June 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: July 30, 2013
• Est. primary completion date: July 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
• insulin detemir
Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.
• insulin aspart
Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

Locations

Country	Name	City	State
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Varna
Finland	Novo Nordisk Investigational Site	Espoo
Finland	Novo Nordisk Investigational Site	Kuopio
Finland	Novo Nordisk Investigational Site	Mikkeli
Finland	Novo Nordisk Investigational Site	OYS
Finland	Novo Nordisk Investigational Site	Pori
France	Novo Nordisk Investigational Site	BRON cedex
France	Novo Nordisk Investigational Site	Paris
France	Novo Nordisk Investigational Site	Rennes
France	Novo Nordisk Investigational Site	Toulouse
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Hannover
Germany	Novo Nordisk Investigational Site	Ludwigshafen
Germany	Novo Nordisk Investigational Site	Münster
Italy	Novo Nordisk Investigational Site	Chieti
Italy	Novo Nordisk Investigational Site	Genova
Italy	Novo Nordisk Investigational Site	Roma
Japan	Novo Nordisk Investigational Site	Chuo-shi, Yamanashi
Japan	Novo Nordisk Investigational Site	Fukushima
Japan	Novo Nordisk Investigational Site	Iruma-gun, Saitama
Japan	Novo Nordisk Investigational Site	Kobe-shi, Hyogo
Japan	Novo Nordisk Investigational Site	Kochi-shi, Kochi
Japan	Novo Nordisk Investigational Site	Kumamoto-shi, Kumamoto
Japan	Novo Nordisk Investigational Site	Maebashi-shi, Gunma
Japan	Novo Nordisk Investigational Site	Musashino-shi, Tokyo
Japan	Novo Nordisk Investigational Site	Niigata-shi, Niigata
Japan	Novo Nordisk Investigational Site	Osaka-shi, Osaka
Japan	Novo Nordisk Investigational Site	Sendai-shi, Miyagi
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Toyonaka-city, Osaka
Japan	Novo Nordisk Investigational Site	Tsu-shi, Mie
Netherlands	Novo Nordisk Investigational Site	Almere
Netherlands	Novo Nordisk Investigational Site	Amersfoort
Netherlands	Novo Nordisk Investigational Site	Eindhoven
Netherlands	Novo Nordisk Investigational Site	Nijmegen
Netherlands	Novo Nordisk Investigational Site	Rotterdam
North Macedonia	Novo Nordisk Investigational Site	Skopje
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Novosibirsk
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Russian Federation	Novo Nordisk Investigational Site	Saratov
Russian Federation	Novo Nordisk Investigational Site	Saratov
South Africa	Novo Nordisk Investigational Site	Cape Town	Western Cape
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
United Kingdom	Novo Nordisk Investigational Site	Aberdeen
United Kingdom	Novo Nordisk Investigational Site	Birmingham
United Kingdom	Novo Nordisk Investigational Site	Manchester
United Kingdom	Novo Nordisk Investigational Site	Norwich
United Kingdom	Novo Nordisk Investigational Site	Sheffield
United States	Novo Nordisk Investigational Site	Akron	Ohio
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Aurora	Colorado
United States	Novo Nordisk Investigational Site	Baltimore	Maryland
United States	Novo Nordisk Investigational Site	Baltimore	Maryland
United States	Novo Nordisk Investigational Site	Boston	Massachusetts
United States	Novo Nordisk Investigational Site	Buffalo	New York
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Gainesville	Florida
United States	Novo Nordisk Investigational Site	Hershey	Pennsylvania
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Lexington	Kentucky
United States	Novo Nordisk Investigational Site	Little Rock	Arkansas
United States	Novo Nordisk Investigational Site	Louisville	Kentucky
United States	Novo Nordisk Investigational Site	Maitland	Florida
United States	Novo Nordisk Investigational Site	Melbourne	Florida
United States	Novo Nordisk Investigational Site	New Haven	Connecticut
United States	Novo Nordisk Investigational Site	Norfolk	Virginia
United States	Novo Nordisk Investigational Site	Orange	California
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania
United States	Novo Nordisk Investigational Site	Richmond	Virginia
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	Tallahassee	Florida
United States	Novo Nordisk Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Finland,  France,  Germany,  Italy,  Japan,  Netherlands,  North Macedonia,  Russian Federation,  South Africa,  United Kingdom, 

References & Publications (2)

Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco AM, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with ty — View Citation

Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)	Change from baseline in HbA1c (%) after 26 weeks of treatment.	Week 0, week 26
Secondary	Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)	Change from baseline in HbA1c (%) after 52 weeks of treatments.	Week 0, week 52
Secondary	Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)	Change from baseline in FPG after 26 weeks of treatment.	Week 0, week 26
Secondary	Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)	Change from baseline in FPG after 52 weeks of treatment.	Week 0, week 52
Secondary	Number of Treatment Emergent Adverse Events (TEAEs)	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.	After 26 weeks and 52 weeks of treatment
Secondary	Number of Hypoglycaemic Episodes	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)	After 26 weeks and 52 weeks of treatment
Secondary	Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))	Episodes of PG >11.1mmol/L (200mg/dL)	After 26 weeks and 52 weeks of treatment
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))	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	After 26 weeks and 52 weeks of treatment
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	Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.	Between week 1 and week 26
Secondary	Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)	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)	After 52 weeks of treatment

External Links

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