DiabetesPhase 3NCT01835431

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

A Phase 3 study testing insulin degludec/insulin aspart, insulin aspart and insulin detemir in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 73 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 1 year to 17 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1
What is being tested?: insulin degludec/insulin aspart, insulin aspart and insulin detemir
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 362 participants
Where: 73 sitesin 15 countries
Study dates: 17 Oct 2013to 7 Nov 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 17 years
All sexes
No healthy volunteers
Child

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

Trial locations and contacts

73 sites in 15 countries.

Country

City, postcode or hospital

73 sites in 15 countries

United States24 sites

Novo Nordisk Investigational Site
Atlanta, Georgia, 30322
Novo Nordisk Investigational Site
Atlanta, Georgia, 30339
Novo Nordisk Investigational Site
Aurora, Colorado, 80045
Novo Nordisk Investigational Site
Baltimore, Maryland, 21229
Novo Nordisk Investigational Site
Buffalo, New York, 14203
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46202
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Kansas City, Missouri, 64111
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Maitland, Florida, 32751
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Phoenix, Arizona, 85053
Novo Nordisk Investigational Site
Sacramento, California, 95816
Novo Nordisk Investigational Site
Springfield, Illinois, 62703
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308
Novo Nordisk Investigational Site
Tampa, Florida, 33612
Novo Nordisk Investigational Site
Tucson, Arizona, 85724
Novo Nordisk Investigational Site
Tulsa, Oklahoma, 74135
Novo Nordisk Investigational Site
Worcester, Massachusetts, 01655

Other trials in United States

India6 sites

Novo Nordisk Investigational Site
Bangalore, Karnataka, 560034
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600086
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500034
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400012
Novo Nordisk Investigational Site
New Dehli, New Delhi, 110029

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Israel6 sites

Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Petah Tikva, 49202
Novo Nordisk Investigational Site
Tel Aviv
Novo Nordisk Investigational Site
Tel HaShomer, 52621
Novo Nordisk Investigational Site
Tsrifin, 70300

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Canada5 sites

Novo Nordisk Investigational Site
London, Ontario, N6A 5W9
Novo Nordisk Investigational Site
Mississauga, Ontario, L5B 1B8
Novo Nordisk Investigational Site
Montreal, Quebec, H3T 1C5
Novo Nordisk Investigational Site
Montreal, Quebec, HIT 2M4
Novo Nordisk Investigational Site
Vancouver, British Columbia, V6H 3V4

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Russia5 sites

Novo Nordisk Investigational Site
Moscow, 125373
Novo Nordisk Investigational Site
Novosibirsk, 630048
Novo Nordisk Investigational Site
Saint Petersburg, 191144
Novo Nordisk Investigational Site
Tomsk, 634050
Novo Nordisk Investigational Site
Ufa, 450106

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Spain5 sites

Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Esplugues Llobregat(Barcelona), 08950
Novo Nordisk Investigational Site
Leganés, 28911
Novo Nordisk Investigational Site
Madrid, 28034
Novo Nordisk Investigational Site
Madrid, 28046

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Belgium3 sites

Novo Nordisk Investigational Site
Brussels, 1090
Novo Nordisk Investigational Site
Brussels, 1200
Novo Nordisk Investigational Site
Leuven, 3000

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Brazil3 sites

Novo Nordisk Investigational Site
Curitiba, Paraná, 80810-040
Novo Nordisk Investigational Site
Porto Alegre, Rio Grande do Sul, 91350-250
Novo Nordisk Investigational Site
São Paulo, São Paulo, 01228-200

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Czechia3 sites

Novo Nordisk Investigational Site
Olomouc, 779 00
Novo Nordisk Investigational Site
Pardubice, 53203
Novo Nordisk Investigational Site
Prague, 15018

Other trials in Czechia

Poland3 sites

Novo Nordisk Investigational Site
Gdansk, 80-952
Novo Nordisk Investigational Site
Warsaw, 04-730
Novo Nordisk Investigational Site
Warsaw, 04-736

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Serbia3 sites

Novo Nordisk Investigational Site
Belgrade, 11070
Novo Nordisk Investigational Site
Niš, 18 000
Novo Nordisk Investigational Site
Novi Sad, 21000

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South Africa3 sites

Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193
Novo Nordisk Investigational Site
Mayville, KwaZulu-Natal, 4058
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0181

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Croatia2 sites

Novo Nordisk Investigational Site
Zagreb, 10 000
Novo Nordisk Investigational Site
Zagreb, 10000

Other trials in Croatia

North Macedonia1 site

Novo Nordisk Investigational Site
Skopje, 1000

Other trials in North Macedonia

Slovenia1 site

Novo Nordisk Investigational Site
Ljubljana, 1525

Other trials in Slovenia

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 1
Being tested: insulin degludec/insulin aspart, insulin aspart, insulin detemir
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

insulin degludec/insulin aspartDrug
Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.
insulin aspartDrug
Administered s.c. with the remaining meals. Dose individually adjusted.
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 aspartDrug
Administered s.c. at meal-times. Dose individually adjusted.

Study groups in NCT01835431
Study group	Role	What they receive
Insulin degludec/insulin aspart	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart; Drug: insulin aspart
Insulin detemir	Active comparator	Not described Receives: Drug: insulin detemir; Drug: insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 0 to week 16

Secondary outcomes (6)

Change From Baseline in Fasting Plasma Glucose
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.
Measured: week 0, week 16
Incidence of Treatment Emergent Adverse Events (TEAEs)
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.
Measured: After 16 weeks of treatment
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)
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.
Measured: After 16 weeks of treatment
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint
Measured: After 16 weeks of treatment
Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill
The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.
Measured: 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)
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
Measured: After 16 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 20137 Nov 2014

First posted19 Apr 2013 (estimated)
Study start17 Oct 2013
Primary completion7 Nov 2014
Study completion7 Nov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 362 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01835431
Sponsor's protocol ID: NN5401-3816
Other IDs: 2012-003566-41, U1111-1133-0958, PIP no. be confirmed
Status last verified: Jun 2019
First submitted: 16 Apr 2013
Last updated: 11 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.
PubMed 30666772
Battelino T, Deeb LC, Ekelund M, Kinduryte O, Klingensmith GJ, Kocova M, Kovarenko M, Shehadeh N. Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial. Pediatr Diabetes. 2018 Nov;19(7):1263-1270. doi: 10.1111/pedi.12724. Epub 2018 Aug 16.
PubMed 30014589

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01835431
Acronym / sponsor ID: NN5401-3816
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 362 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 17 Oct 2013 (actual)
Primary completion: 7 Nov 2014 (actual)
Study completion: 7 Nov 2014 (actual)
First posted: 19 Apr 2013 (estimated)
Results: Posted 17 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin degludec/insulin aspart	Experimental	Drug: insulin degludec/insulin aspart, Drug: insulin aspart
Insulin detemir	Active comparator	Drug: insulin detemir, Drug: insulin aspart

Who may qualify

Ages: 1 year to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludec/insulin aspartAdministered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.	Drug	Insulin degludec/insulin aspart
insulin aspartAdministered s.c. with the remaining meals. Dose individually adjusted.	Drug	Insulin degludec/insulin aspart
insulin detemirAdministered 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 detemir
insulin aspartAdministered s.c. at meal-times. Dose individually adjusted.	Drug	Insulin detemir

Primary outcome

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.

6 secondary outcomes

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

Results and safety

Results posted to the registry on 17 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDegAsp OD	182	174
IDet OD/BID	180	168

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)

Time frame: Week 0 to week 16. Mean (Standard Deviation). Unit: percentage (%)

Measure	IDegAsp OD n = 173	IDet OD/BID n = 165
Value	-0.3 (1.0)	-0.3 (0.9)

Population analysed: The FAS included all randomised subjects. 20 subjects were withdrawn and only 4 subjects though completed the study did not have assesments.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDegAsp OD	11 of 181 (6.1%)	96 of 181 (53%)	Not reported
IDet OD/BID	7 of 179 (3.9%)	97 of 179 (54.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30666772Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.
Results publication: PubMed 30014589Battelino T, Deeb LC, Ekelund M, Kinduryte O, Klingensmith GJ, Kocova M, Kovarenko M, Shehadeh N. Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial. Pediatr Diabetes. 2018 Nov;19(7):1263-1270. doi: 10.1111/pedi.12724. Epub 2018 Aug 16.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

73 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec/insulin aspart, insulin aspart and insulin detemir in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 73 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, India, Israel, Canada, Russia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) (time frame: Week 0 to week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01835431, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.