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
NCT ID: NCT02670915
Last Updated: 2019-06-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
834 participants
INTERVENTIONAL
2016-05-04
2018-03-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus
NCT01513473
A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
NCT03407599
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes
NCT02825251
A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes
NCT03215498
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
NCT01835431
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Meal-time faster-acting insulin aspart and insulin degludec
Faster-acting insulin aspart
For subcutaneous (s.c., under the skin) injection once daily.
insulin degludec
For subcutaneous (s.c., under the skin) injection once daily.
Meal-time NovoRapid® (insulin aspart) and insulin degludec
insulin aspart
For subcutaneous (s.c., under the skin) injection once daily.
insulin degludec
For subcutaneous (s.c., under the skin) injection once daily.
Post-meal faster-acting insulin aspart and insulin degludec
Faster-acting insulin aspart
For subcutaneous (s.c., under the skin) injection once daily.
insulin degludec
For subcutaneous (s.c., under the skin) injection once daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Faster-acting insulin aspart
For subcutaneous (s.c., under the skin) injection once daily.
insulin aspart
For subcutaneous (s.c., under the skin) injection once daily.
insulin degludec
For subcutaneous (s.c., under the skin) injection once daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
1 Year
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Sacramento, California, United States
Novo Nordisk Investigational Site
Ventura, California, United States
Novo Nordisk Investigational Site
Aurora, Colorado, United States
Novo Nordisk Investigational Site
Gainesville, Florida, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Orlando, Florida, United States
Novo Nordisk Investigational Site
Tallahassee, Florida, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Boise, Idaho, United States
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States
Novo Nordisk Investigational Site
Springfield, Illinois, United States
Novo Nordisk Investigational Site
Lexington, Kentucky, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States
Novo Nordisk Investigational Site
Neptune City, New Jersey, United States
Novo Nordisk Investigational Site
Buffalo, New York, United States
Novo Nordisk Investigational Site
Mineola, New York, United States
Novo Nordisk Investigational Site
Raleigh, North Carolina, United States
Novo Nordisk Investigational Site
Fargo, North Dakota, United States
Novo Nordisk Investigational Site
Columbus, Ohio, United States
Novo Nordisk Investigational Site
Tulsa, Oklahoma, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States
Novo Nordisk Investigational Site
Sioux Falls, South Dakota, United States
Novo Nordisk Investigational Site
Amarillo, Texas, United States
Novo Nordisk Investigational Site
Austin, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States
Novo Nordisk Investigational Site
Pleven, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Varna, , Bulgaria
Novo Nordisk Investigational Site
Hradec Králové, , Czechia
Novo Nordisk Investigational Site
Opava, , Czechia
Novo Nordisk Investigational Site
Ostrava - Poruba, , Czechia
Novo Nordisk Investigational Site
Pardubice, , Czechia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Ústí nad Labem, , Czechia
Novo Nordisk Investigational Site
Tallinn, , Estonia
Novo Nordisk Investigational Site
Tartu, , Estonia
Novo Nordisk Investigational Site
Espoo, , Finland
Novo Nordisk Investigational Site
OYS, , Finland
Novo Nordisk Investigational Site
Seinäjoki, , Finland
Novo Nordisk Investigational Site
Bochum, , Germany
Novo Nordisk Investigational Site
Freiburg im Breisgau, , Germany
Novo Nordisk Investigational Site
Hanover, , Germany
Novo Nordisk Investigational Site
Ludwigshafen, , Germany
Novo Nordisk Investigational Site
Münster, , Germany
Novo Nordisk Investigational Site
Neuwied, , Germany
Novo Nordisk Investigational Site
Oldenburg, , Germany
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, , Germany
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India
Novo Nordisk Investigational Site
Kochi, Kerala, India
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
Pune, Maharashtra, India
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India
Novo Nordisk Investigational Site
Kolkata, , India
Novo Nordisk Investigational Site
New Delhi, , India
Novo Nordisk Investigational Site
Beersheba, , Israel
Novo Nordisk Investigational Site
Haifa, , Israel
Novo Nordisk Investigational Site
Holon, , Israel
Novo Nordisk Investigational Site
Petah Tikva, , Israel
Novo Nordisk Investigational Site
Tel Aviv, , Israel
Novo Nordisk Investigational Site
Ẕerifin, , Israel
Novo Nordisk Investigational Site
Ancona, , Italy
Novo Nordisk Investigational Site
Catanzaro, , Italy
Novo Nordisk Investigational Site
Chieti, , Italy
Novo Nordisk Investigational Site
Napoli, , Italy
Novo Nordisk Investigational Site
Verona, , Italy
Novo Nordisk Investigational Site
Amagasaki-shi, Hyogo, , Japan
Novo Nordisk Investigational Site
Chuo-shi, Yamanashi, , Japan
Novo Nordisk Investigational Site
Fukuoka, , Japan
Novo Nordisk Investigational Site
Hiroshima-shi, Hiroshima, , Japan
Novo Nordisk Investigational Site
Iruma-gun, Saitama, , Japan
Novo Nordisk Investigational Site
Kitakyushu,Fukuoka, , Japan
Novo Nordisk Investigational Site
Kitakyushu-shi, Fukuoka, , Japan
Novo Nordisk Investigational Site
Kobe-shi, Hyogo, , Japan
Novo Nordisk Investigational Site
Kobe-shi, Hyogo, , Japan
Novo Nordisk Investigational Site
Kochi-shi, Kochi, , Japan
Novo Nordisk Investigational Site
Kofu, Yamanashi, , Japan
Novo Nordisk Investigational Site
Kumamoto-shi, Kumamoto, , Japan
Novo Nordisk Investigational Site
Kure-shi, Hiroshima, , Japan
Novo Nordisk Investigational Site
Kyoto, , Japan
Novo Nordisk Investigational Site
Maebashi-shi, Gunma, , Japan
Novo Nordisk Investigational Site
Matsumoto-shi, Nagano,, , Japan
Novo Nordisk Investigational Site
Matsuyama-shi, Ehime, , Japan
Novo Nordisk Investigational Site
Musashino-shi, Tokyo, , Japan
Novo Nordisk Investigational Site
Niigata-shi, Niigata, , Japan
Novo Nordisk Investigational Site
Niigata-shi, Niigata, , Japan
Novo Nordisk Investigational Site
Okayama Kita-ku, Okayama, , Japan
Novo Nordisk Investigational Site
Okayama-shi, Okayama, , Japan
Novo Nordisk Investigational Site
Okayama-shi, Okayama, , Japan
Novo Nordisk Investigational Site
Osaka-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Ota-shi, Gunma, , Japan
Novo Nordisk Investigational Site
Otsu-shi, Shiga, , Japan
Novo Nordisk Investigational Site
Saga-shi, Saga, , Japan
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, , Japan
Novo Nordisk Investigational Site
Suzaka-shi ,Nagano, , Japan
Novo Nordisk Investigational Site
Tochigi, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tsu-shi, Mie, , Japan
Novo Nordisk Investigational Site
Yokohama-shi, Kanagawa, , Japan
Novo Nordisk Investigational Site
Yokosuka-shi, Kanagawa, , Japan
Novo Nordisk Investigational Site
Riga, , Latvia
Novo Nordisk Investigational Site
Kaunas, , Lithuania
Novo Nordisk Investigational Site
Gdansk, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Wroclaw, , Poland
Novo Nordisk Investigational Site
San Juan, , Puerto Rico
Novo Nordisk Investigational Site
Kazan', , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Novosibirsk, , Russia
Novo Nordisk Investigational Site
Rostov-on-Don, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Samara, , Russia
Novo Nordisk Investigational Site
Saratov, , Russia
Novo Nordisk Investigational Site
Tomsk, , Russia
Novo Nordisk Investigational Site
Ufa, , Russia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Niš, , Serbia
Novo Nordisk Investigational Site
Novi Sad, , Serbia
Novo Nordisk Investigational Site
Adana, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Antalya, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Izmir, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Izmir, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Samsun, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Dnipro, , Ukraine
Novo Nordisk Investigational Site
Ivano-Frankivsk, , Ukraine
Novo Nordisk Investigational Site
Kharkiv, , Ukraine
Novo Nordisk Investigational Site
Kharkiv, , Ukraine
Novo Nordisk Investigational Site
Kiev, , Ukraine
Novo Nordisk Investigational Site
Kyiv, , Ukraine
Novo Nordisk Investigational Site
Lviv, , Ukraine
Novo Nordisk Investigational Site
Vinnytsia, , Ukraine
Novo Nordisk Investigational Site
Zaporizhzhia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-002568-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1158-1170
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-163248
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-4101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.