NCT01835431|CompletedPhase 3Results

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 A/S ClinicalTrials.gov

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4 other identifiers

NN5401-38162012-003566-41U1111-1133-0958PIP no. be confirmed

Study Type

interventional

Target

362

Locations

15 countries

Sites

Timeline

RegisteredApr 2013

StartedOct 2013

CompletionNov 2014

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

362

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Oct 2013

Geographic Reach

15 countries

73 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

1.1 years study duration

First Submitted

Initial submission to the registry

April 16, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed

6 months until next milestone

Study Start

First participant enrolled

October 17, 2013

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2014

Completed

1 year until next milestone

Results Posted

Study results publicly available

November 17, 2015

Completed

Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

April 16, 2013

Results QC Date

October 13, 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) (%)
Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.
Week 0 to week 16

Secondary Outcomes (6)

Change From Baseline in Fasting Plasma Glucose
week 0, week 16
Incidence of Treatment Emergent Adverse Events (TEAEs)
After 16 weeks of treatment
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)
After 16 weeks of treatment
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
After 16 weeks of treatment
Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill
After 16 weeks of treatment
+1 more secondary outcomes

Study Arms (2)

Insulin degludec/insulin aspart

EXPERIMENTAL

Drug: insulin degludec/insulin aspartDrug: insulin aspart

Insulin detemir

ACTIVE COMPARATOR

Drug: insulin detemirDrug: insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.

Insulin degludec/insulin aspart

insulin aspartDRUG

Administered s.c. with the remaining meals. Dose individually adjusted.

Insulin degludec/insulin aspart

insulin detemirDRUG

Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.

Insulin detemir

Eligibility Criteria

Age1 Year - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Contact the study team to confirm eligibility.