NCT01513473|CompletedPhase 3Results

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

BEGIN™

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)

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN1250-35612011-003148-39P/44/2010U1111-1122-4758

Study Type

interventional

Target

350

Locations

12 countries

Sites

Timeline

RegisteredJan 2012

StartedJan 2012

CompletionJul 2013

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

350

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jan 2012

Typical duration for phase_3 diabetes

Geographic Reach

12 countries

81 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

January 16, 2012

Completed

Same day until next milestone

Study Start

First participant enrolled

January 16, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2013

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

January 12, 2016

Completed

Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

January 16, 2012

Results QC Date

October 12, 2015

Last Update Submit

June 3, 2019

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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 Outcomes (9)

Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
Week 0, week 52
Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
Week 0, week 26
Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
Week 0, week 52
Number of Treatment Emergent Adverse Events (TEAEs)
After 26 weeks and 52 weeks of treatment
Number of Hypoglycaemic Episodes
After 26 weeks and 52 weeks of treatment
+4 more secondary outcomes

Study Arms (2)

Insulin Degludec + Insulin Aspart

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

Insulin Detemir +Insulin Aspart

EXPERIMENTAL

Drug: insulin detemirDrug: insulin aspart

Interventions

insulin degludecDRUG

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

Insulin Degludec + Insulin Aspart

insulin detemirDRUG

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

Insulin Detemir +Insulin Aspart

insulin aspartDRUG

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

Insulin Degludec + Insulin AspartInsulin Detemir +Insulin Aspart

Eligibility Criteria

Age1 Year - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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%

You may not qualify if:

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

Contact the study team to confirm eligibility.