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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01835431
First received: April 16, 2013
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin degludec/insulin aspart
Drug: insulin aspart
Drug: insulin detemir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) [ Time Frame: Week 0 to week 16 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    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.

  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.

  • Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint

  • 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 ] [ Designated as safety issue: No ]
    The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.

  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 362
Study Start Date: October 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835431

  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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01835431     History of Changes
Other Study ID Numbers: NN5401-3816  2012-003566-41  U1111-1133-0958  PIP no. be confirmed 
Study First Received: April 16, 2013
Results First Received: October 13, 2015
Last Updated: January 26, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Croatia: Ministry of Health and Social Care
Israel: Ministry of Health
Macedonia, The Former Yugoslav Republic of: Ministry of Health
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Serbia: Agency for Drugs and Medicinal Devices
Slovenia: Agency for Medicinal Products - Ministry of Health
South Africa: Medicines Control Council
Spain: Ministry of Health
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 21, 2016