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

June 3, 2019 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
362

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Novo Nordisk Investigational Site
      • Brussels, Belgium, 1200
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
  • Brazil
    • Parana
      • Curitiba, Parana, Brazil, 80810-040
        • Novo Nordisk Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-250
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01228-200
        • Novo Nordisk Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Novo Nordisk Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Novo Nordisk Investigational Site
      • Mississauga, Ontario, Canada, L5B 1B8
        • Novo Nordisk Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, HIT 2M4
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H3T 1C5
        • Novo Nordisk Investigational Site
  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10000
        • Novo Nordisk Investigational Site
  • Czechia
      • Olomouc, Czechia, 779 00
        • Novo Nordisk Investigational Site
      • Pardubice, Czechia, 53203
        • Novo Nordisk Investigational Site
      • Prague 5, Czechia, 15018
        • Novo Nordisk Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400012
        • Novo Nordisk Investigational Site
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 31096
        • Novo Nordisk Investigational Site
      • Petah Tikva, Israel, 49202
        • Novo Nordisk Investigational Site
      • Tel Aviv, Israel
        • Novo Nordisk Investigational Site
      • Tel Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
      • Zerifin, Israel, 70300
        • Novo Nordisk Investigational Site
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Novo Nordisk Investigational Site
  • Poland
      • Gdansk, Poland, 80-952
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 04-730
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 04-736
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 125373
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630048
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191144
        • Novo Nordisk Investigational Site
      • Tomsk, Russian Federation, 634050
        • Novo Nordisk Investigational Site
      • Ufa, Russian Federation, 450106
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11070
        • Novo Nordisk Investigational Site
      • Nis, Serbia, 18 000
        • Novo Nordisk Investigational Site
      • Novi Sad, Serbia, 21000
        • Novo Nordisk Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1525
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0181
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Mayville, KwaZulu-Natal, South Africa, 4058
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Esplugues Llobregat(Barcelona), Spain, 08950
        • Novo Nordisk Investigational Site
      • Leganés, Spain, 28911
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28034
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85724
        • Novo Nordisk Investigational Site
    • California
      • Sacramento, California, United States, 95816
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Maitland, Florida, United States, 32751
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33612
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62703
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Novo Nordisk Investigational Site
    • New York
      • Buffalo, New York, United States, 14203
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: insulin aspart
Administered s.c. at meal-times. Dose individually adjusted.
Active Comparator: Insulin detemir
Drug: insulin aspart
Administered s.c. with the remaining meals. Dose individually adjusted.
Drug: insulin aspart
Administered s.c. at meal-times. 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 0 to week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
week 0, week 16
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.
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

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.
After 16 weeks of treatment
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
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
The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.
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
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
After 16 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN5401-3816
  • 2012-003566-41 (EudraCT Number)
  • U1111-1133-0958 (Other Identifier: WHO)
  • PIP no. be confirmed (Other Identifier: EMA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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