Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
NCT ID: NCT01074268
Last Updated: 2017-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
456 participants
INTERVENTIONAL
2010-02-28
2010-12-31
Brief Summary
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The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.
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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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IDeg OD
insulin degludec
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
insulin aspart
Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.
IDet
insulin detemir
Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.
insulin aspart
Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.
Interventions
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insulin degludec
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
insulin detemir
Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.
insulin aspart
Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Current treatment with any basal bolus insulin for at least 12 months
* HbA1c below or equal to 10.0%
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* For Japan only: Minimum age is 20 years
* For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)
Exclusion Criteria
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Cancer and medical history of cancer
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
Caba, , Argentina
Novo Nordisk Investigational Site
Ciudad Autónoma de Bs As, , Argentina
Novo Nordisk Investigational Site
Mar del Plata, , Argentina
Novo Nordisk Investigational Site
Rosario, , Argentina
Novo Nordisk Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Novo Nordisk Investigational Site
São Paulo, São Paulo, Brazil
Novo Nordisk Investigational Site
Marília, , Brazil
Novo Nordisk Investigational Site
Porto Alegre, , Brazil
Novo Nordisk Investigational Site
São Paulo, , Brazil
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Hämeenlinna, , Finland
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Helsinki, , Finland
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Kuopio, , Finland
Novo Nordisk Investigational Site
Lahti, , Finland
Novo Nordisk Investigational Site
Seinäjoki, , Finland
Novo Nordisk Investigational Site
Tampere, , Finland
Novo Nordisk Investigational Site
Turku, , Finland
Novo Nordisk Investigational Site
Bangalore, Karnataka, India
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India
Novo Nordisk Investigational Site
Ahmedabad, , India
Novo Nordisk Investigational Site
Bilāspur, , India
Novo Nordisk Investigational Site
Dhantoli, Nagpur, , India
Novo Nordisk Investigational Site
Hyderabad, , India
Novo Nordisk Investigational Site
New Dehli, , India
Novo Nordisk Investigational Site
Ramdaspeth / Nagpur, , India
Novo Nordisk Investigational Site
Thriruvananthapuram, , India
Novo Nordisk Investigational Site
Bari, , Italy
Novo Nordisk Investigational Site
Forlì, , Italy
Novo Nordisk Investigational Site
Gazi, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
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Olbia, , Italy
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Palermo, , Italy
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Partinico, , Italy
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Roma, , Italy
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Torino, , Italy
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Treviglio, , Italy
Novo Nordisk Investigational Site
Treviso, , Italy
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Ebina-shi, , Japan
Novo Nordisk Investigational Site
Imizu-shi, , Japan
Novo Nordisk Investigational Site
Izumisano, , Japan
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, , Japan
Novo Nordisk Investigational Site
Kumamoto-shi,Kumamoto, , Japan
Novo Nordisk Investigational Site
Miyazaki, , Japan
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, , Japan
Novo Nordisk Investigational Site
Nishinomiya-shi, Hygo, , Japan
Novo Nordisk Investigational Site
Ota-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Ōita, , Japan
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Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
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Sapporo-shi, Hokkaido, , Japan
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Yokohama, , Japan
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Skopje, , North Macedonia
Novo Nordisk Investigational Site
Bath, , United Kingdom
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Blackburn, , United Kingdom
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Carmarthen, , United Kingdom
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Edinburgh, , United Kingdom
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Leicester, , United Kingdom
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Manchester, , United Kingdom
Novo Nordisk Investigational Site
Middlesbrough, , United Kingdom
Novo Nordisk Investigational Site
Northampton, , United Kingdom
Novo Nordisk Investigational Site
Nottingham, , United Kingdom
Novo Nordisk Investigational Site
Penarth, , United Kingdom
Novo Nordisk Investigational Site
Plymouth, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Novo Nordisk Investigational Site
Torquay, , United Kingdom
Novo Nordisk Investigational Site
Wirral, Merseyside, , United Kingdom
Countries
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References
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Davies MJ, Gross JL, Ono Y, Sasaki T, Bantwal G, Gall MA, Niemeyer M, Seino H; BEGIN BB T1 Study Group. Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial. Diabetes Obes Metab. 2014 Oct;16(10):922-30. doi: 10.1111/dom.12298. Epub 2014 May 8.
Davies M, Sasaki T, Gross JL, Bantwal G, Ono Y, Nishida T, Tojjar D, Seino H. Comparison of insulin degludec with insulin detemir in type 1 diabetes: a 1-year treat-to-target trial. Diabetes Obes Metab. 2016 Jan;18(1):96-9. doi: 10.1111/dom.12573. Epub 2015 Oct 19.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2009-011672-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1111-7249
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-101067
Identifier Type: REGISTRY
Identifier Source: secondary_id
2009-015721-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1114-9479
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-22-0677
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN1250-3585
Identifier Type: -
Identifier Source: org_study_id
NCT01190956
Identifier Type: -
Identifier Source: nct_alias
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