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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date May 4, 2016
Completion Date March 3, 2018
Primary Completion Date February 5, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in the Percentage of HbA1c Week 0, Week 26
Secondary Outcome
Measure Time Frame
Change in 8-point SMPG Profile: Mean PPG Over All Three Meals Week 0, Week 26
Change in 8-point SMPG Profile: PPG Increment Over All Three Meals Week 0, Week 26
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Week 0, Week 26
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment Week 0, Week 26
Change in 8-point SMPG Profile: Mean of the 8-point Profile Week 0, Week 26
Fluctuation in the 8-point SMPG Profile Week 26
Change in FPG Week 0, Week 26
Change in 1,5-anhydroglucitol Week 0, Week 26
Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines Week 26
Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia Week 26
Insulin Dose (Units/Day): Total Basal Week 26
Insulin Dose (Units/Day): Total Bolus Week 26
Insulin Dose (Units/Day): Individual Meal Insulin Dose Week 26
Insulin Dose (Units/kg/Day): Total Basal Week 26
Insulin Dose (Units/kg/Day): Total Bolus Week 26
Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose Week 26
Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) Week 0, Week 26
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) Week 26
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) Week 26
Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included Week 26
Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) Week 0, Week 26
Change in Mean IG Peak After Start of Meal Week 0, Week 26
Change in Mean Time to the IG Peak After Meal Week 0, Week 26
Change in 30-minute PPG Week 0, Week 26
Change in 30-minute PPG Increment Week 0, Week 26
Change in 1-hour PPG Week 0, Week 26
Change in 1-hour PPG Increment Week 0, Week 26
Change in 2-hour PPG Week 0, Week 26
Change in 2-hour PPG Increment Week 0, Week 26
Change in AUCIG,0-15min Week 0, Week 26
Change in AUCIG,0-30min Week 0, Week 26
Change in AUCIG,0-1h Week 0, Week 26
Change in AUCIG,0-2h Week 0, Week 26
Change in AUCIG,0-4h Week 0, Week 26
Change in Time to the IG Peak After Start of Meal Week 0, Week 26
Change in IG Peak After Start of Meal Week 0, Week 26
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total Week 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime Week 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Week 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total Week 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime Week 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) Week 0-26
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Week 0-26
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Week 0-26
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Week 0-26
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification Week 0-26
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 Week 0-26
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 Week 0-26
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 Week 0-26
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification Week 0-26
Number of Treatment Emergent Adverse Events (AEs) Week 0-26
Number of Treatment Emergent Injection Site Reactions Week 0-26
Change in Physical Examination Week 0, Week 26
Change in Vital Sign: Blood Pressure Week 0, Week 26
Change in Vital Sign: Pulse Week 0, Week 26
Change in Body Weight Week 0, Week 26
Change in Height Week 0, Week 26
Change in Body Mass Index Week 0, Week 26
Change in SD Score of Body Weight Week 0, Week 26
Change in SD Score of Body Mass Index Week 0, Week 26
Change in Haematology: Haemoglobin Week 0, Week 26
Change in Haematology: Haematocrit Week 0, Week 26
Change in Haematology: Erythrocytes Week 0, Week 26
Change in Haematology: Thrombocytes Week 0, Week 26
Change in Haematology: Leukocytes Week 0, Week 26
Change in Biochemistry: Creatinine Week 0, Week 26
Change in Biochemistry: Alanine Aminotransferase (ALT) Week 0, Week 26
Change in Biochemistry: Aspartate Aminotransferase (AST) Week 0, Week 26
Change in Biochemistry: Alkaline Phosphatase (AP) Week 0, Week 26
Change in Biochemistry: Sodium Week 0, Week 26
Change in Biochemistry: Potassium Week 0, Week 26
Change in Biochemistry: Albumin Week 0, Week 26
Change in Biochemistry: Total Bilirubin Week 0, Week 26
Change in Lipid Profile: Total Cholesterol Week 0, Week 26
Change in Lipid Profile: High Density Lipoproteins (HDL) Week 0, Week 26
Change in Lipid Profile: Low Density Lipoproteins (LDL) Week 0, Week 26
Change in Anti-insulin Aspart Antibody Development: Specific Week 0, Week 26
Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin Week 0, Week 26
Change in Anti-insulin Aspart Antibody Development: Total Week 0, Week 26
Enrollment 834
Condition
Intervention

Intervention Type: Drug

Intervention Name: Faster-acting insulin aspart

Description: For subcutaneous (s.c., under the skin) injection once daily.

Intervention Type: Drug

Intervention Name: insulin aspart

Description: For subcutaneous (s.c., under the skin) injection once daily.

Arm Group Label: Meal-time NovoRapid® (insulin aspart) and insulin degludec

Intervention Type: Drug

Intervention Name: insulin degludec

Description: For subcutaneous (s.c., under the skin) injection once daily.

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

Gender: All

Minimum Age: 1 Year

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Novo Nordisk Investigational Site | Phoenix, Arizona, 85053, United States
Novo Nordisk Investigational Site | Tucson, Arizona, 85724, United States
Novo Nordisk Investigational Site | Long Beach, California, 90806, United States
Novo Nordisk Investigational Site | Los Angeles, California, 90027, United States
Novo Nordisk Investigational Site | Sacramento, California, 95821, United States
Novo Nordisk Investigational Site | Ventura, California, 93003, United States
Novo Nordisk Investigational Site | Aurora, Colorado, 80045, United States
Novo Nordisk Investigational Site | Gainesville, Florida, 32608, United States
Novo Nordisk Investigational Site | Jacksonville, Florida, 32207, United States
Novo Nordisk Investigational Site | Orlando, Florida, 32806, United States
Novo Nordisk Investigational Site | Tallahassee, Florida, 32308, United States
Novo Nordisk Investigational Site | Tampa, Florida, 33612, United States
Novo Nordisk Investigational Site | Atlanta, Georgia, 30339, United States
Novo Nordisk Investigational Site | Boise, Idaho, 83712, United States
Novo Nordisk Investigational Site | Idaho Falls, Idaho, 83404-7596, United States
Novo Nordisk Investigational Site | Springfield, Illinois, 62702, United States
Novo Nordisk Investigational Site | Lexington, Kentucky, 40503, United States
Novo Nordisk Investigational Site | Baltimore, Maryland, 21229, United States
Novo Nordisk Investigational Site | Boston, Massachusetts, 02215, United States
Novo Nordisk Investigational Site | Minneapolis, Minnesota, 55416, United States
Novo Nordisk Investigational Site | Minneapolis, Minnesota, 55455, United States
Novo Nordisk Investigational Site | Las Vegas, Nevada, 89128, United States
Novo Nordisk Investigational Site | Neptune, New Jersey, 07753, United States
Novo Nordisk Investigational Site | Buffalo, New York, 14203, United States
Novo Nordisk Investigational Site | Mineola, New York, 11501, United States
Novo Nordisk Investigational Site | Raleigh, North Carolina, 27610, United States
Novo Nordisk Investigational Site | Fargo, North Dakota, 58122, United States
Novo Nordisk Investigational Site | Columbus, Ohio, 43205, United States
Novo Nordisk Investigational Site | Tulsa, Oklahoma, 74135, United States
Novo Nordisk Investigational Site | Philadelphia, Pennsylvania, 19104, United States
Novo Nordisk Investigational Site | Philadelphia, Pennsylvania, 19107, United States
Novo Nordisk Investigational Site | Pittsburgh, Pennsylvania, 15224, United States
Novo Nordisk Investigational Site | Sioux Falls, South Dakota, 57105, United States
Novo Nordisk Investigational Site | Amarillo, Texas, 79106, United States
Novo Nordisk Investigational Site | Austin, Texas, 78731, United States
Novo Nordisk Investigational Site | Dallas, Texas, 75231, United States
Novo Nordisk Investigational Site | Dallas, Texas, 75235, United States
Novo Nordisk Investigational Site | Salt Lake City, Utah, 84132, United States
Novo Nordisk Investigational Site | Pleven, 5800, Bulgaria
Novo Nordisk Investigational Site | Sofia, 1407, Bulgaria
Novo Nordisk Investigational Site | Sofia, 1606, Bulgaria
Novo Nordisk Investigational Site | Varna, 9010, Bulgaria
Novo Nordisk Investigational Site | Hradec Kralove, 50005, Czechia
Novo Nordisk Investigational Site | Opava, 746001, Czechia
Novo Nordisk Investigational Site | Ostrava - Poruba, 70852, Czechia
Novo Nordisk Investigational Site | Pardubice, 53203, Czechia
Novo Nordisk Investigational Site | Praha, 10034, Czechia
Novo Nordisk Investigational Site | Usti nad Labem, 40113, Czechia
Novo Nordisk Investigational Site | Tallinn, 13419, Estonia
Novo Nordisk Investigational Site | Tartu, 51014, Estonia
Novo Nordisk Investigational Site | Espoo, 02740, Finland
Novo Nordisk Investigational Site | OYS, 90029, Finland
Novo Nordisk Investigational Site | Seinäjoki, 60220, Finland
Novo Nordisk Investigational Site | Bochum, 44791, Germany
Novo Nordisk Investigational Site | Freiburg, 79106, Germany
Novo Nordisk Investigational Site | Hannover, 30173, Germany
Novo Nordisk Investigational Site | Ludwigshafen, 67059, Germany
Novo Nordisk Investigational Site | Münster, 48155, Germany
Novo Nordisk Investigational Site | Neuwied, 56564, Germany
Novo Nordisk Investigational Site | Oldenburg, 23758, Germany
Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach, 66386, Germany
Novo Nordisk Investigational Site | Hyderabad, Andhra Pradesh, 500003, India
Novo Nordisk Investigational Site | Hyderabad, Andhra Pradesh, 500072, India
Novo Nordisk Investigational Site | Ahmedabad, Gujarat, 380007, India
Novo Nordisk Investigational Site | Kochi, Kerala, 682041, India
Novo Nordisk Investigational Site | Indore, Madhya Pradesh, 452010, India
Novo Nordisk Investigational Site | Mumbai, Maharashtra, 400010, India
Novo Nordisk Investigational Site | Pune, Maharashtra, 411001, India
Novo Nordisk Investigational Site | Chennai, Tamil Nadu, 600 013, India
Novo Nordisk Investigational Site | Kolkata, 700026, India
Novo Nordisk Investigational Site | New Delhi, 110060, India
Novo Nordisk Investigational Site | Beer Sheva, 84101, Israel
Novo Nordisk Investigational Site | Haifa, 31096, Israel
Novo Nordisk Investigational Site | Holon, 58100, Israel
Novo Nordisk Investigational Site | Petah Tikva, 49202, Israel
Novo Nordisk Investigational Site | Tel Aviv, Israel
Novo Nordisk Investigational Site | Zerifin, 70300, Israel
Novo Nordisk Investigational Site | Ancona, 60123, Italy
Novo Nordisk Investigational Site | Catanzaro, 88100, Italy
Novo Nordisk Investigational Site | Chieti, 66100, Italy
Novo Nordisk Investigational Site | Napoli, 80131, Italy
Novo Nordisk Investigational Site | Verona, 37126, Italy
Novo Nordisk Investigational Site | Amagasaki-shi, Hyogo, 661-0965, Japan
Novo Nordisk Investigational Site | Chuo-shi, Yamanashi, 409 3898, Japan
Novo Nordisk Investigational Site | Fukuoka, 830-0011, Japan
Novo Nordisk Investigational Site | Hiroshima-shi, Hiroshima, 734-8530, Japan
Novo Nordisk Investigational Site | Iruma-gun, Saitama, 350 0495, Japan
Novo Nordisk Investigational Site | Kitakyushu,Fukuoka, 8078556, Japan
Novo Nordisk Investigational Site | Kitakyushu-shi, Fukuoka, 806-8501, Japan
Novo Nordisk Investigational Site | Kobe-shi, Hyogo, 650-0047, Japan
Novo Nordisk Investigational Site | Kobe-shi, Hyogo, 657-0846, Japan
Novo Nordisk Investigational Site | Kochi-shi, Kochi, 780 0952, Japan
Novo Nordisk Investigational Site | Kofu, Yamanashi, 400-0027, Japan
Novo Nordisk Investigational Site | Kumamoto-shi, Kumamoto, 860 8556, Japan
Novo Nordisk Investigational Site | Kure-shi, Hiroshima, 737-0023, Japan
Novo Nordisk Investigational Site | Kyoto, 602-8566, Japan
Novo Nordisk Investigational Site | Maebashi-shi, Gunma, 371-8511, Japan
Novo Nordisk Investigational Site | Matsumoto-shi, Nagano,, 399-8701, Japan
Novo Nordisk Investigational Site | Matsuyama-shi, Ehime, 790-8524, Japan
Novo Nordisk Investigational Site | Musashino-shi, Tokyo, 180 0023, Japan
Novo Nordisk Investigational Site | Niigata-shi, Niigata, 950 1197, Japan
Novo Nordisk Investigational Site | Niigata-shi, Niigata, 951 8520, Japan
Novo Nordisk Investigational Site | Okayama Kita-ku, Okayama, 700-8607, Japan
Novo Nordisk Investigational Site | Okayama-shi, Okayama, 700-0013, Japan
Novo Nordisk Investigational Site | Okayama-shi, Okayama, 701-1192, Japan
Novo Nordisk Investigational Site | Osaka-shi, Osaka, 545 8586, Japan
Novo Nordisk Investigational Site | Ota-shi, Gunma, 373-8585, Japan
Novo Nordisk Investigational Site | Otsu-shi, Shiga, 520-0804, Japan
Novo Nordisk Investigational Site | Saga-shi, Saga, 840-0801, Japan
Novo Nordisk Investigational Site | Sendai-shi, Miyagi, 980 8574, Japan
Novo Nordisk Investigational Site | Suzaka-shi ,Nagano, 382-0091, Japan
Novo Nordisk Investigational Site | Tochigi, 329-0498, Japan
Novo Nordisk Investigational Site | Tokyo, 101-8309, Japan
Novo Nordisk Investigational Site | Tokyo, 157 8535, Japan
Novo Nordisk Investigational Site | Tokyo, 162 8666, Japan
Novo Nordisk Investigational Site | Tsu-shi, Mie, 514 0125, Japan
Novo Nordisk Investigational Site | Yokohama-shi, Kanagawa, 232-0024, Japan
Novo Nordisk Investigational Site | Yokosuka-shi, Kanagawa, 238-8567, Japan
Novo Nordisk Investigational Site | Riga, LV1004, Latvia
Novo Nordisk Investigational Site | Kaunas, 50009, Lithuania
Novo Nordisk Investigational Site | Gdansk, 80-952, Poland
Novo Nordisk Investigational Site | Warszawa, 04-730, Poland
Novo Nordisk Investigational Site | Warszawa, 04-736, Poland
Novo Nordisk Investigational Site | Wroclaw, 50-368, Poland
Novo Nordisk Investigational Site | San Juan, 00927, Puerto Rico
Novo Nordisk Investigational Site | Kazan, 420073, Russian Federation
Novo Nordisk Investigational Site | Moscow, 117036, Russian Federation
Novo Nordisk Investigational Site | Moscow, 125373, Russian Federation
Novo Nordisk Investigational Site | Novosibirsk, 630048, Russian Federation
Novo Nordisk Investigational Site | Rostov-on-Don, 344013, Russian Federation
Novo Nordisk Investigational Site | Saint-Petersburg, 191036, Russian Federation
Novo Nordisk Investigational Site | Samara, 443079, Russian Federation
Novo Nordisk Investigational Site | Saratov, 410054, Russian Federation
Novo Nordisk Investigational Site | Tomsk, 634050, Russian Federation
Novo Nordisk Investigational Site | Ufa, 450106, Russian Federation
Novo Nordisk Investigational Site | Belgrade, 11000, Serbia
Novo Nordisk Investigational Site | Belgrade, 11070, Serbia
Novo Nordisk Investigational Site | Nis, 18 000, Serbia
Novo Nordisk Investigational Site | Novi Sad, 21000, Serbia
Novo Nordisk Investigational Site | Adana, 01130, Turkey
Novo Nordisk Investigational Site | Antalya, 07059, Turkey
Novo Nordisk Investigational Site | Istanbul, 34093, Turkey
Novo Nordisk Investigational Site | Istanbul, 34668, Turkey
Novo Nordisk Investigational Site | İzmir, 35040, Turkey
Novo Nordisk Investigational Site | Izmir, 35340, Turkey
Novo Nordisk Investigational Site | Samsun, 55139, Turkey
Novo Nordisk Investigational Site | Dnipro, 49023, Ukraine
Novo Nordisk Investigational Site | Ivano-Frankivsk, 76018, Ukraine
Novo Nordisk Investigational Site | Kharkiv, 61093, Ukraine
Novo Nordisk Investigational Site | Kharkiv, 61153, Ukraine
Novo Nordisk Investigational Site | Kiev, 01021, Ukraine
Novo Nordisk Investigational Site | Kyiv, 04114, Ukraine
Novo Nordisk Investigational Site | Lviv, 79010, Ukraine
Novo Nordisk Investigational Site | Vinnytsia, 21010, Ukraine
Novo Nordisk Investigational Site | Zaporizhzhia, 69063, Ukraine
Location Countries

Bulgaria

Czechia

Estonia

Finland

Germany

India

Israel

Italy

Japan

Latvia

Lithuania

Poland

Puerto Rico

Russian Federation

Serbia

Turkey

Ukraine

United States

Verification Date

May 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Meal-time faster-acting insulin aspart and insulin degludec

Type: Experimental

Label: Meal-time NovoRapid® (insulin aspart) and insulin degludec

Type: Active Comparator

Label: Post-meal faster-acting insulin aspart and insulin degludec

Type: Experimental

Acronym onset®7
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov