Clinical trial NCT02670915: Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes
Official title: Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes
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: 2016-02-02
Enrollment: 834
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 globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.


Eligibility criteria: Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening

Primary outcomes:
measure: Change in the Percentage of HbA1c
timeFrame: Week 0, Week 26
Secondary outcomes:
measure: Change in 8-point SMPG Profile: Mean PPG Over All Three Meals
timeFrame: Week 0, Week 26
measure: Change in 8-point SMPG Profile: PPG Increment Over All Three Meals
timeFrame: Week 0, Week 26
measure: Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG
timeFrame: Week 0, Week 26
measure: Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment
timeFrame: Week 0, Week 26
measure: Change in 8-point SMPG Profile: Mean of the 8-point Profile
timeFrame: Week 0, Week 26
measure: Fluctuation in the 8-point SMPG Profile
timeFrame: Week 26
measure: Change in FPG
timeFrame: Week 0, Week 26
measure: Change in 1,5-anhydroglucitol
timeFrame: Week 0, Week 26
measure: Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines
timeFrame: Week 26
measure: Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia
timeFrame: Week 26
measure: Insulin Dose (Units/Day): Total Basal
timeFrame: Week 26
measure: Insulin Dose (Units/Day): Total Bolus
timeFrame: Week 26
measure: Insulin Dose (Units/Day): Individual Meal Insulin Dose
timeFrame: Week 26
measure: Insulin Dose (Units/kg/Day): Total Basal
timeFrame: Week 26
measure: Insulin Dose (Units/kg/Day): Total Bolus
timeFrame: Week 26
measure: Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose
timeFrame: Week 26
measure: Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])
timeFrame: Week 0, Week 26
measure: Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
timeFrame: Week 26
measure: Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
timeFrame: Week 26
measure: Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included
timeFrame: Week 26
measure: Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)
timeFrame: Week 0, Week 26
measure: Change in Mean IG Peak After Start of Meal
timeFrame: Week 0, Week 26
measure: Change in Mean Time to the IG Peak After Meal
timeFrame: Week 0, Week 26
measure: Change in 30-minute PPG
timeFrame: Week 0, Week 26
measure: Change in 30-minute PPG Increment
timeFrame: Week 0, Week 26
measure: Change in 1-hour PPG
timeFrame: Week 0, Week 26
measure: Change in 1-hour PPG Increment
timeFrame: Week 0, Week 26
measure: Change in 2-hour PPG
timeFrame: Week 0, Week 26
measure: Change in 2-hour PPG Increment
timeFrame: Week 0, Week 26
measure: Change in AUCIG,0-15min
timeFrame: Week 0, Week 26
measure: Change in AUCIG,0-30min
timeFrame: Week 0, Week 26
measure: Change in AUCIG,0-1h
timeFrame: Week 0, Week 26
measure: Change in AUCIG,0-2h
timeFrame: Week 0, Week 26
measure: Change in AUCIG,0-4h
timeFrame: Week 0, Week 26
measure: Change in Time to the IG Peak After Start of Meal
timeFrame: Week 0, Week 26
measure: Change in IG Peak After Start of Meal
timeFrame: Week 0, Week 26
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total
timeFrame: Week 0-26
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime
timeFrame: Week 0-26
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
timeFrame: Week 0-26
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total
timeFrame: Week 0-26
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime
timeFrame: Week 0-26
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
timeFrame: Week 0-26
measure: Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
timeFrame: Week 0-26
measure: Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
timeFrame: Week 0-26
measure: Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
timeFrame: Week 0-26
measure: Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
timeFrame: Week 0-26
measure: Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
timeFrame: Week 0-26
measure: Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
timeFrame: Week 0-26
measure: Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
timeFrame: Week 0-26
measure: Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
timeFrame: Week 0-26
measure: Number of Treatment Emergent Adverse Events (AEs)
timeFrame: Week 0-26
measure: Number of Treatment Emergent Injection Site Reactions
timeFrame: Week 0-26
measure: Change in Physical Examination
timeFrame: Week 0, Week 26
measure: Change in Vital Sign: Blood Pressure
timeFrame: Week 0, Week 26
measure: Change in Vital Sign: Pulse
timeFrame: Week 0, Week 26
measure: Change in Body Weight
timeFrame: Week 0, Week 26
measure: Change in Height
timeFrame: Week 0, Week 26
measure: Change in Body Mass Index
timeFrame: Week 0, Week 26
measure: Change in SD Score of Body Weight
timeFrame: Week 0, Week 26
measure: Change in SD Score of Body Mass Index
timeFrame: Week 0, Week 26
measure: Change in Haematology: Haemoglobin
timeFrame: Week 0, Week 26
measure: Change in Haematology: Haematocrit
timeFrame: Week 0, Week 26
measure: Change in Haematology: Erythrocytes
timeFrame: Week 0, Week 26
measure: Change in Haematology: Thrombocytes
timeFrame: Week 0, Week 26
measure: Change in Haematology: Leukocytes
timeFrame: Week 0, Week 26
measure: Change in Biochemistry: Creatinine
timeFrame: Week 0, Week 26
measure: Change in Biochemistry: Alanine Aminotransferase (ALT)
timeFrame: Week 0, Week 26
measure: Change in Biochemistry: Aspartate Aminotransferase (AST)
timeFrame: Week 0, Week 26
measure: Change in Biochemistry: Alkaline Phosphatase (AP)
timeFrame: Week 0, Week 26
measure: Change in Biochemistry: Sodium
timeFrame: Week 0, Week 26
measure: Change in Biochemistry: Potassium
timeFrame: Week 0, Week 26
measure: Change in Biochemistry: Albumin
timeFrame: Week 0, Week 26
measure: Change in Biochemistry: Total Bilirubin
timeFrame: Week 0, Week 26
measure: Change in Lipid Profile: Total Cholesterol
timeFrame: Week 0, Week 26
measure: Change in Lipid Profile: High Density Lipoproteins (HDL)
timeFrame: Week 0, Week 26
measure: Change in Lipid Profile: Low Density Lipoproteins (LDL)
timeFrame: Week 0, Week 26
measure: Change in Anti-insulin Aspart Antibody Development: Specific
timeFrame: Week 0, Week 26
measure: Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin
timeFrame: Week 0, Week 26
measure: Change in Anti-insulin Aspart Antibody Development: Total
timeFrame: Week 0, Week 26
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: Long Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Sacramento
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Ventura
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Aurora
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Gainesville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
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: Boise
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
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: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Neptune
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Buffalo
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Mineola
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Raleigh
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Novo Nordisk Investigational Site
state: North Dakota
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
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: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Novo Nordisk Investigational Site
state: South Dakota
city: Amarillo
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Pleven
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Varna
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Hradec Kralove
country: Czechia
facility: Novo Nordisk Investigational Site
city: Opava
country: Czechia
facility: Novo Nordisk Investigational Site
city: Ostrava - Poruba
country: Czechia
facility: Novo Nordisk Investigational Site
city: Pardubice
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha
country: Czechia
facility: Novo Nordisk Investigational Site
city: Usti nad Labem
country: Czechia
facility: Novo Nordisk Investigational Site
city: Tallinn
country: Estonia
facility: Novo Nordisk Investigational Site
city: Tartu
country: Estonia
facility: Novo Nordisk Investigational Site
city: Espoo
country: Finland
facility: Novo Nordisk Investigational Site
city: OYS
country: Finland
facility: Novo Nordisk Investigational Site
city: Seinäjoki
country: Finland
facility: Novo Nordisk Investigational Site
city: Bochum
country: Germany
facility: Novo Nordisk Investigational Site
city: Freiburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuwied
country: Germany
facility: Novo Nordisk Investigational Site
city: Oldenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Kochi
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Indore
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Beer Sheva
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Holon
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: Zerifin
country: Israel
facility: Novo Nordisk Investigational Site
city: Ancona
country: Italy
facility: Novo Nordisk Investigational Site
city: Catanzaro
country: Italy
facility: Novo Nordisk Investigational Site
city: Chieti
country: Italy
facility: Novo Nordisk Investigational Site
city: Napoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Verona
country: Italy
facility: Novo Nordisk Investigational Site
city: Amagasaki-shi, Hyogo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-shi, Yamanashi
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Hiroshima-shi, Hiroshima
country: Japan
facility: Novo Nordisk Investigational Site
city: Iruma-gun, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Kitakyushu,Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kitakyushu-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kobe-shi, Hyogo
country: Japan
facility: Novo Nordisk Investigational Site
city: Kobe-shi, Hyogo
country: Japan
facility: Novo Nordisk Investigational Site
city: Kochi-shi, Kochi
country: Japan
facility: Novo Nordisk Investigational Site
city: Kofu, Yamanashi
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi, Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Kure-shi, Hiroshima
country: Japan
facility: Novo Nordisk Investigational Site
city: Kyoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Maebashi-shi, Gunma
country: Japan
facility: Novo Nordisk Investigational Site
city: Matsumoto-shi, Nagano,
country: Japan
facility: Novo Nordisk Investigational Site
city: Matsuyama-shi, Ehime
country: Japan
facility: Novo Nordisk Investigational Site
city: Musashino-shi, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Niigata-shi, Niigata
country: Japan
facility: Novo Nordisk Investigational Site
city: Niigata-shi, Niigata
country: Japan
facility: Novo Nordisk Investigational Site
city: Okayama Kita-ku, Okayama
country: Japan
facility: Novo Nordisk Investigational Site
city: Okayama-shi, Okayama
country: Japan
facility: Novo Nordisk Investigational Site
city: Okayama-shi, Okayama
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Ota-shi, Gunma
country: Japan
facility: Novo Nordisk Investigational Site
city: Otsu-shi, Shiga
country: Japan
facility: Novo Nordisk Investigational Site
city: Saga-shi, Saga
country: Japan
facility: Novo Nordisk Investigational Site
city: Sendai-shi, Miyagi
country: Japan
facility: Novo Nordisk Investigational Site
city: Suzaka-shi ,Nagano
country: Japan
facility: Novo Nordisk Investigational Site
city: Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tsu-shi, Mie
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokosuka-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Riga
country: Latvia
facility: Novo Nordisk Investigational Site
city: Kaunas
country: Lithuania
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: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
city: San Juan
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Kazan
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
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: Rostov-on-Don
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Samara
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
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: 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: Adana
country: Turkey
facility: Novo Nordisk Investigational Site
city: Antalya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: İzmir
country: Turkey
facility: Novo Nordisk Investigational Site
city: Izmir
country: Turkey
facility: Novo Nordisk Investigational Site
city: Samsun
country: Turkey
facility: Novo Nordisk Investigational Site
city: Dnipro
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kharkiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kharkiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kiev
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Lviv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Vinnytsia
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Bode BW, Iotova V, Kovarenko M, Laffel LM, Rao PV, Deenadayalan S, Ekelund M, Larsen SF, Danne T. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. Diabetes Care. 2019 Jul;42(7):1255-1262. doi: 10.2337/dc19-0009. Epub 2019 May 10.