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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Diabetes; Diabetes Mellitus, Type 1	Drug: insulin degludec/insulin aspart; Drug: insulin aspart; Drug: insulin detemir	Phase 3

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	362 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official 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
Study Start Date :	October 2013
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	November 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Insulin degludec/insulin aspart	Drug: insulin degludec/insulin aspart; Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted. Drug: insulin aspart; Administered s.c. with the remaining meals. Dose individually adjusted.
Active Comparator: Insulin detemir	Drug: insulin detemir; 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. Drug: insulin aspart; Administered s.c. at meal-times. Dose individually adjusted.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change From Baseline in Fasting Plasma Glucose [ Time Frame: week 0, week 16 ]
   Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.
2. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: After 16 weeks of treatment ]
   A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment.
3. 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 ]

   Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia).

   Confirmed hypoglycaemic episodes were defined as episodes that were either:

   1. Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or
   2. An episode biochemically confirmed by PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
4. Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: After 16 weeks of treatment ]
   The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint
5. 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 ]
   The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.
6. 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 ]
   The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	1 Year to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 35 Study Locations

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Clinical Trials at Novo Nordisk 

Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01835431 History of Changes
Other Study ID Numbers:	NN5401-3816; 2012-003566-41 ( EudraCT Number ); U1111-1133-0958 ( Other Identifier: WHO ); PIP no. be confirmed ( Other Identifier: EMA )
First Posted:	April 19, 2013
Results First Posted:	November 17, 2015
Last Update Posted:	February 26, 2016
Last Verified:	January 2016

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin, Globin Zinc	Insulin degludec, insulin aspart drug combination; Insulin; Insulin Aspart; Insulin, Long-Acting; Insulin Detemir; Hypoglycemic Agents; Physiological Effects of Drugs