A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin aspart

Drug: insulin degludec/insulin aspart

Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01835431

NN5401-3816

2012-003566-41 (EudraCT Number)

PIP no. be confirmed (Other Identifier)

U1111-1133-0958 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.

Enrollment

362 patients

Sex

All

Ages

1 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Subjects diagnosed with type 1 diabetes mellitus - HbA1c below or equal to 11.0% Exclusion Criteria: - Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator - More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening) - Any chronic disorder or significant concomitant disease, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol