Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
NCT ID: NCT00978627
Last Updated: 2017-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
548 participants
INTERVENTIONAL
2009-08-31
2010-05-31
Brief Summary
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The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.
The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDegAsp OD
insulin degludec/insulin aspart
Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.
insulin aspart
Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.
IDet
insulin detemir
Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.
insulin aspart
Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.
Interventions
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insulin degludec/insulin aspart
Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.
insulin detemir
Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.
insulin aspart
Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.
insulin aspart
Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes mellitus for at least 12 months
* Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
* HbA1c 7.0-10.0% (both inclusive)
* BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
* FOR THE EXTENSION TRIAL, NN5401-3645:
* The subject must have completed the six-month treatment period in trial NN5401-3594
Exclusion Criteria
* Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer
* FOR THE EXTENSION TRIAL, NN5401-3645:
* Anticipated significant lifestyle changes during the trial
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
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
La Mesa, California, United States
Novo Nordisk Investigational Site
Lancaster, California, United States
Novo Nordisk Investigational Site
Mission Hills, California, United States
Novo Nordisk Investigational Site
North Hollywood, California, United States
Novo Nordisk Investigational Site
Salinas, California, United States
Novo Nordisk Investigational Site
Valencia, California, United States
Novo Nordisk Investigational Site
Aurora, Colorado, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Lawrenceville, Georgia, United States
Novo Nordisk Investigational Site
Roswell, Georgia, United States
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Honolulu, Hawaii, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, United States
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Lexington, Kentucky, United States
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Eagan, Minnesota, United States
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Minneapolis, Minnesota, United States
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City of Saint Peters, Missouri, United States
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Butte, Montana, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
Novo Nordisk Investigational Site
Albany, New York, United States
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Northport, New York, United States
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Morehead City, North Carolina, United States
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Greer, South Carolina, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Seattle, Washington, United States
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Broadmeadow, New South Wales, Australia
Novo Nordisk Investigational Site
Camperdown, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Keswick, South Australia, Australia
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Box Hill, Victoria, Australia
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Fitzroy, , Australia
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Geelong, , Australia
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Aalborg, , Denmark
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Århus C, , Denmark
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Gentofte Municipality, , Denmark
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Auxerre, , France
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Narbonne, , France
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Nîmes, , France
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Pointe à Pitre, , France
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Petah Tikva, , Israel
Novo Nordisk Investigational Site
Rishon LeZiyyon, , Israel
Novo Nordisk Investigational Site
Tel Litwinsky, , Israel
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Lodz, , Poland
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Lodz, , Poland
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Sopot, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Bayamón, , Puerto Rico
Novo Nordisk Investigational Site
Brasov, Brașov County, Romania
Novo Nordisk Investigational Site
Buzău, Buzău, Romania
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
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Bucharest, , Romania
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Iași, , Romania
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Oradea, , Romania
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Sibiu, , Romania
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Kemerovo, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Penza, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Samara, , Russia
Novo Nordisk Investigational Site
Saratov, , Russia
Novo Nordisk Investigational Site
Saratov, , Russia
Novo Nordisk Investigational Site
Smolensk, , Russia
Novo Nordisk Investigational Site
Volgograd, , Russia
Novo Nordisk Investigational Site
Bristol, , United Kingdom
Novo Nordisk Investigational Site
Dundee, , United Kingdom
Novo Nordisk Investigational Site
Edinburgh, , United Kingdom
Novo Nordisk Investigational Site
Leicester, , United Kingdom
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Liverpool, , United Kingdom
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Oxford, , United Kingdom
Novo Nordisk Investigational Site
Salford, , United Kingdom
Novo Nordisk Investigational Site
Wirral, Merseyside, , United Kingdom
Countries
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References
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Hirsch IB, Franek E, Mersebach H, Bardtrum L, Hermansen K. Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOST(R) T1). Diabet Med. 2017 Feb;34(2):167-173. doi: 10.1111/dme.13068. Epub 2016 Feb 19.
Hirsch IB, Bode B, Courreges JP, Dykiel P, Franek E, Hermansen K, King A, Mersebach H, Davies M. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care. 2012 Nov;35(11):2174-81. doi: 10.2337/dc11-2503. Epub 2012 Aug 28.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-005769-71
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1111-8943
Identifier Type: OTHER
Identifier Source: secondary_id
2009-013412-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1113-2475
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-3594
Identifier Type: -
Identifier Source: org_study_id
NCT01087606
Identifier Type: -
Identifier Source: nct_alias
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