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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin degludec/insulin aspart
insulin aspart
insulin detemir
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers
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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin degludec/insulin aspart

Insulin detemir

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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: 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 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
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
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)
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

Full Information

First Posted
April 16, 2013
Last Updated
June 3, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01835431
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 17, 2013 (Actual)
Primary Completion Date
November 7, 2014 (Actual)
Study Completion Date
November 7, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin degludec/insulin aspart
Arm Type
Experimental
Arm Title
Insulin detemir
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Administered s.c. with the remaining meals. Dose individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Administered s.c. at meal-times. Dose individually adjusted.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
Description
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.
Time Frame
Week 0 to week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose
Description
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.
Time Frame
week 0, week 16
Title
Incidence of Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
After 16 weeks of treatment
Title
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)
Description
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: 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 An episode biochemically confirmed by PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
Time Frame
After 16 weeks of treatment
Title
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
Description
The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint
Time Frame
After 16 weeks of treatment
Title
Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill
Description
The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.
Time Frame
After 16 weeks of treatment
Title
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)
Description
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
Time Frame
After 16 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7596
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
HIT 2M4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Prague 5
ZIP/Postal Code
15018
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel Aviv
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
04-736
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
125373
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630048
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
191144
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Ufa
ZIP/Postal Code
450106
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Mayville
State/Province
KwaZulu-Natal
ZIP/Postal Code
4058
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Esplugues Llobregat(Barcelona)
ZIP/Postal Code
08950
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Leganés
ZIP/Postal Code
28911
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30666772
Citation
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.
Results Reference
background
PubMed Identifier
30014589
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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