Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
NCT ID: NCT00612040
Last Updated: 2017-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
178 participants
INTERVENTIONAL
2008-01-31
2008-06-30
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
NONE
Study Groups
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SIBA (D)
insulin degludec
Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
SIBA (E)
insulin degludec
Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
IGlar
insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
Interventions
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insulin degludec
Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
insulin degludec
Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
Eligibility Criteria
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Inclusion Criteria
* HbA1c 7-11% (both inclusive)
* Treated with insulin for at least six months - any regimen
Exclusion Criteria
* Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product
18 Years
75 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
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States
Novo Nordisk Investigational Site
Des Moines, Iowa, United States
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Renton, Washington, United States
Novo Nordisk Investigational Site
Wollongong, New South Wales, Australia
Novo Nordisk Investigational Site
Keswick, South Australia, Australia
Novo Nordisk Investigational Site
East Ringwood, Victoria, Australia
Novo Nordisk Investigational Site
Geelong, , Australia
Novo Nordisk Investigational Site
Miranda, , Australia
Novo Nordisk Investigational Site
Aschaffenburg, , Germany
Novo Nordisk Investigational Site
Bad Kreuznach, , Germany
Novo Nordisk Investigational Site
Dresden, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Hohenmölsen, , Germany
Novo Nordisk Investigational Site
Neuwied, , Germany
Novo Nordisk Investigational Site
Saint Ingbert, , Germany
Novo Nordisk Investigational Site
Bergen, , Norway
Novo Nordisk Investigational Site
Bergen, , Norway
Novo Nordisk Investigational Site
Elverum, , Norway
Novo Nordisk Investigational Site
Kristiansand, , Norway
Novo Nordisk Investigational Site
Oslo, , Norway
Novo Nordisk Investigational Site
Stavanger, , Norway
Novo Nordisk Investigational Site
Alingsås, , Sweden
Novo Nordisk Investigational Site
Karlstad, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Stockholm, , Sweden
Novo Nordisk Investigational Site
Stockholm, , Sweden
Novo Nordisk Investigational Site
Umeå, , Sweden
Countries
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References
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Birkeland KI, Home PD, Wendisch U, Ratner RE, Johansen T, Endahl LA, Lyby K, Jendle JH, Roberts AP, DeVries JH, Meneghini LF. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care. 2011 Mar;34(3):661-5. doi: 10.2337/dc10-1925. Epub 2011 Jan 26.
Home PD, Meneghini L, Wendisch U, Ratner RE, Johansen T, Christensen TE, Jendle J, Roberts AP, Birkeland KI. Improved health status with insulin degludec compared with insulin glargine in people with type 1 diabetes. Diabet Med. 2012 Jun;29(6):716-20. doi: 10.1111/j.1464-5491.2011.03547.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2007-002474-60
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1250-1835
Identifier Type: -
Identifier Source: org_study_id
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