Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes
NCT ID: NCT02825251
Last Updated: 2019-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
472 participants
INTERVENTIONAL
2016-07-06
2017-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Faster-acting insulin aspart CSII
Faster-acting insulin aspart
Injected s.c. /subcutaneously (under the skin)
NovoRapid® CSII
insulin aspart
Injected s.c. /subcutaneously (under the skin)
Interventions
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Faster-acting insulin aspart
Injected s.c. /subcutaneously (under the skin)
insulin aspart
Injected s.c. /subcutaneously (under the skin)
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
* Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
* HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
* Body mass index (BMI) below or equal to 35.0 kg/m\^2 at screening
* Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial
* Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol
Exclusion Criteria
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Encino, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
Roseville, California, United States
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San Mateo, California, United States
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San Ramon, California, United States
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Santa Barbara, California, United States
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Walnut Creek, California, United States
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Newark, Delaware, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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Arlington Heights, Illinois, United States
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Lexington, Kentucky, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Albany, New York, United States
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Asheville, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Chattanooga, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Mesquite, Texas, United States
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Federal Way, Washington, United States
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Renton, Washington, United States
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Arlon, , Belgium
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Bonheiden, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Sint-Niklaas, , Belgium
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Wilrijk, , Belgium
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Edmonton, Alberta, Canada
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Barrie, Ontario, Canada
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Concord, Ontario, Canada
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London, Ontario, Canada
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Oakville, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, , Canada
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Caen, , France
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La Rochelle, , France
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Le Creusot, , France
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Montpellier, , France
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Narbonne, , France
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Paris, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Toulouse, , France
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Vénissieux, , France
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Bad Mergentheim, , Germany
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Essen, , Germany
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Friedrichsthal, , Germany
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Hamburg, , Germany
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Ludwigshafen, , Germany
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Münster, , Germany
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Neuwied, , Germany
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Rehlingen-Siersburg, , Germany
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Rostock, , Germany
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Amsterdam, , Netherlands
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Apeldoorn, , Netherlands
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Eindhoven, , Netherlands
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Hoofddorp, , Netherlands
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Hoogeveen, , Netherlands
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Leiden, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Utrecht, , Netherlands
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Venlo, , Netherlands
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Cheboksary, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Novosibirsk, , Russia
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Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Yoshkar-Ola, , Russia
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Ljubljana, , Slovenia
Novo Nordisk Investigational Site
Novo Mesto, , Slovenia
Novo Nordisk Investigational Site
Cambridge, , United Kingdom
Novo Nordisk Investigational Site
Guildford, , United Kingdom
Novo Nordisk Investigational Site
Harrogate, North Yorkshire, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Manchester, , United Kingdom
Novo Nordisk Investigational Site
St Helens, , United Kingdom
Countries
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References
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Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.
Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.
Gorst-Rasmussen A, Sturis J, Ekelund M. Continuous Glucose Monitoring Sensor Glucose Levels and Insulin Pump Infusion Set Wear-Time During Treatment with Fast-Acting Insulin Aspart: A Post Hoc Analysis of Onset 5. Diabetes Technol Ther. 2022 Jan;24(1):10-17. doi: 10.1089/dia.2021.0199. Epub 2021 Dec 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2010-024054-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1118-2480
Identifier Type: OTHER
Identifier Source: secondary_id
NL54555.018.16
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-3854
Identifier Type: -
Identifier Source: org_study_id
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