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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin detemir; Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01513473

P/44/2010 (Other Identifier)

2011-003148-39 (EudraCT Number)

NN1250-3561

U1111-1122-4758 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Insulin Degludec + Insulin Aspart

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

Insulin Detemir +Insulin Aspart

Experimental group

Treatment:

Drug: insulin detemir

Drug: insulin aspart