Clinical trial NCT01835431: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 362
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
timeFrame: Week 0 to week 16
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: week 0, week 16
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: After 16 weeks of treatment
measure: Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)
timeFrame: After 16 weeks of treatment
measure: Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
timeFrame: After 16 weeks of treatment
measure: Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill
timeFrame: After 16 weeks of treatment
measure: 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)
timeFrame: After 16 weeks of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Sacramento
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Aurora
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Maitland
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Springfield
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Worcester
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Buffalo
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Tulsa
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Leuven
country: Belgium
facility: Novo Nordisk Investigational Site
city: Curitiba
country: Brazil
facility: Novo Nordisk Investigational Site
state: Parana
city: Porto Alegre
country: Brazil
facility: Novo Nordisk Investigational Site
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Olomouc
country: Czechia
facility: Novo Nordisk Investigational Site
city: Pardubice
country: Czechia
facility: Novo Nordisk Investigational Site
city: Prague 5
country: Czechia
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: New Dehli
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Beer Sheva
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Zerifin
country: Israel
facility: Novo Nordisk Investigational Site
city: Skopje
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tomsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Ufa
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Nis
country: Serbia
facility: Novo Nordisk Investigational Site
city: Novi Sad
country: Serbia
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Mayville
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Esplugues Llobregat(Barcelona)
country: Spain
facility: Novo Nordisk Investigational Site
city: Leganés
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.
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.