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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01835431
• Date of registration: 16/04/2013
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: 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
• Scientific title: 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
• Date of first enrolment: October 17, 2013
• Target sample size: 362
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01835431
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Brazil, Canada, Croatia, Czech Republic, Czechia, India, Israel, Macedonia, The Former Yugoslav Republic of, North Macedonia, Poland, Russian Federation, Serbia, Slovenia, South Africa, Spain, United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & 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



Age minimum: 1 Year
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Diabetes

Intervention(s)

Drug: insulin detemir

Drug: insulin aspart

Drug: insulin degludec/insulin aspart

Primary Outcome(s)

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) [Time Frame: Week 0 to week 16]

Secondary Outcome(s)

Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill [Time Frame: After 16 weeks of treatment]

Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L) [Time Frame: After 16 weeks of treatment]

Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia) [Time Frame: After 16 weeks of treatment]

Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes [Time Frame: After 16 weeks of treatment]

Change From Baseline in Fasting Plasma Glucose [Time Frame: week 0, week 16]

Incidence of Treatment Emergent Adverse Events (TEAEs) [Time Frame: After 16 weeks of treatment]

Secondary ID(s)

2012-003566-41

U1111-1133-0958

NN5401-3816

PIP no. be confirmed

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/11/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01835431