Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01835431
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : November 17, 2015
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE April 16, 2013
First Posted Date  ICMJE April 19, 2013
Results First Submitted Date  ICMJE October 13, 2015
Results First Posted Date  ICMJE November 17, 2015
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE October 17, 2013
Actual Primary Completion Date November 7, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2013)
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) [ Time Frame: Week 0, week 16 ]
Change History Complete list of historical versions of study NCT01835431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Insulin degludec/insulin aspart
    Interventions:
    • Drug: insulin degludec/insulin aspart
    • Drug: insulin aspart
  • Active Comparator: Insulin detemir
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin aspart
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2014)
362
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2013)
346
Actual Study Completion Date  ICMJE November 7, 2014
Actual Primary Completion Date November 7, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   Croatia,   Czechia,   India,   Israel,   North Macedonia,   Poland,   Russian Federation,   Serbia,   Slovenia,   South Africa,   Spain,   United States
Removed Location Countries Czech Republic,   Macedonia, The Former Yugoslav Republic of
 
Administrative Information
NCT Number  ICMJE NCT01835431
Other Study ID Numbers  ICMJE NN5401-3816
2012-003566-41 ( EudraCT Number )
U1111-1133-0958 ( Other Identifier: WHO )
PIP no. be confirmed ( Other Identifier: EMA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP