Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
NCT ID: NCT00614055
Last Updated: 2017-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
178 participants
INTERVENTIONAL
2008-01-31
2008-07-31
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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Insulin glargine
insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
metformin
Tablets, 1500-2000 mg/day
SIAC 30 (B)
insulin degludec/insulin aspart
Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
metformin
Tablets, 1500-2000 mg/day
SIAC 45 (B)
insulin degludec/insulin aspart
Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
metformin
Tablets, 1500-2000 mg/day
Interventions
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insulin degludec/insulin aspart
Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
insulin degludec/insulin aspart
Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
metformin
Tablets, 1500-2000 mg/day
Eligibility Criteria
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Inclusion Criteria
* Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
* Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 month at a stable maximum tolerated dose or at least half maximum allowed dose according to locally approved summary of product characteristics (SPC)
* HbA1c, 7.0 - 11.0 % (both inclusive)
* Body Mass Index (BMI), 25.0 - 37.0 kg/m\^2 (both inclusive)
Exclusion Criteria
* Thiazolidinedione (TZD) treatments within the previous three months prior to Visit 1
* Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
* 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
Alès, , France
Novo Nordisk Investigational Site
Brest, , France
Novo Nordisk Investigational Site
La Rochelle, , France
Novo Nordisk Investigational Site
Le Creusot, , France
Novo Nordisk Investigational Site
Mont-de-Marsan, , France
Novo Nordisk Investigational Site
Vénissieux, , France
Novo Nordisk Investigational Site
Bad Kreuznach, , Germany
Novo Nordisk Investigational Site
Bad Mergentheim, , Germany
Novo Nordisk Investigational Site
Dormagen, , Germany
Novo Nordisk Investigational Site
Hohenmölsen, , Germany
Novo Nordisk Investigational Site
Neuss, , Germany
Novo Nordisk Investigational Site
Neuwied, , Germany
Novo Nordisk Investigational Site
Elverum, , Norway
Novo Nordisk Investigational Site
Hamar, , Norway
Novo Nordisk Investigational Site
Kongsvinger, , Norway
Novo Nordisk Investigational Site
Oslo, , Norway
Novo Nordisk Investigational Site
Stavanger, , Norway
Novo Nordisk Investigational Site
Tromsø, , Norway
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Almería, , Spain
Novo Nordisk Investigational Site
Partida de Bacarot, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
Novo Nordisk Investigational Site
Valencia, , Spain
Novo Nordisk Investigational Site
Valladolid, , Spain
Countries
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References
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Heise T, Tack CJ, Cuddihy R, Davidson J, Gouet D, Liebl A, Romero E, Mersebach H, Dykiel P, Jorde R. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011 Mar;34(3):669-74. doi: 10.2337/dc10-1905. Epub 2011 Feb 1.
Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4.
Liebl A, Davidson J, Mersebach H, Dykiel P, Tack CJ, Heise T. A novel insulin combination of insulin degludec and insulin aspart achieves a more stable overnight glucose profile than insulin glargine: results from continuous glucose monitoring in a proof-of-concept trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1328-36. doi: 10.1177/193229681300700524.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2007-002476-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN5401-1791
Identifier Type: -
Identifier Source: org_study_id
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