A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.
NCT ID: NCT02607306
Last Updated: 2021-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
819 participants
INTERVENTIONAL
2015-11-18
2017-12-22
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 degludec/liraglutide OD
insulin degludec/liraglutide
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
Insulin degludec OD
insulin degludec
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
Liraglutide OD
liraglutide
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
Interventions
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insulin degludec/liraglutide
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
insulin degludec
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
liraglutide
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
* HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
* Body-mass index (BMI) above or equal to 20 kg/m\^2
* Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling
* Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism
* Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal
* Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* Screening calcitonin equal to or above 50 ng/L
* History of pancreatitis (acute or chronic)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Adachi-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Akita-shi, Akita, , Japan
Novo Nordisk Investigational Site
Annaka-shi, Gunma, , Japan
Novo Nordisk Investigational Site
Asahikawa-shi, Hokkaido, , Japan
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Chiba-shi, Chiba, , Japan
Novo Nordisk Investigational Site
Chitose, Hokkaido, , Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, , Japan
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Chuo-ku,Tokyo, , Japan
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Chūōku, , Japan
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Edogawa-ku, Tokyo, , Japan
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Fujisawa-shi, Kanagawa, , Japan
Novo Nordisk Investigational Site
Fukuoka-shi, Fukuoka, , Japan
Novo Nordisk Investigational Site
Fukushima, , Japan
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Gunma, , Japan
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Hachioji-shi, Tokyo, , Japan
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Hokkaido, , Japan
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Hokkaido, , Japan
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Ibaraki, , Japan
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Ichihara-shi, Chiba, , Japan
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Iruma-shi, Saitama, , Japan
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Itabashi-ku, Tokyo, , Japan
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Itabashi-ku, Tokyo, , Japan
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Izumisano, , Japan
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Izumisano-shi,Osaka, , Japan
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Kagoshima-shi, Kagoshima, , Japan
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Kamakura-shi, , Japan
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Kanagawa, , Japan
Novo Nordisk Investigational Site
Kanra-gun, Gunma, , Japan
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Kashiwara-shi, Osaka, , Japan
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Kawagoe-shi, Saitama, , Japan
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Kawaguchi-shi, Saitama, , Japan
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Kawasaki-shi,Kanagawa, , Japan
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Kisarazu-shi, Chiba, , Japan
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Kobe-shi, Hyogo, , Japan
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Kuki-shi, Saitama, , Japan
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Kumamoto, , Japan
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Kumamoto-shi, Kumamoto, , Japan
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Kumamoto-shi, Kumamoto, , Japan
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Kushiro-shi, Hokkaido, , Japan
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Kyoto-shi, Kyoto, , Japan
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Minato-ku, Tokyo, , Japan
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Mito-shi, Ibaraki, , Japan
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Mito-shi, Ibaraki, , Japan
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Miura-shi, Kanagawa, , Japan
Novo Nordisk Investigational Site
Miyazaki, , Japan
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Nagoya-shi, Aichi, , Japan
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Nagoya-shi, Aichi, , Japan
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Nishinomiya-shi, Hygo, , Japan
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Obihiro-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Obihiro-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Okawa-shi, Fukuoka, , Japan
Novo Nordisk Investigational Site
Onga-gun, Fukuoka, , Japan
Novo Nordisk Investigational Site
Osaka, , Japan
Novo Nordisk Investigational Site
Osaka-shi, Osaka, , Japan
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Osaka-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Osaka-shi, Osaka, , Japan
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Ota-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Ōita, , Japan
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Saijo-shi, Ehime, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, , Japan
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, , Japan
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, , Japan
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, , Japan
Novo Nordisk Investigational Site
Tochigi, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Toshima-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Toyonaka-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Ube-shi, Yamaguchi, , Japan
Novo Nordisk Investigational Site
Urasoe-shi,, , Japan
Novo Nordisk Investigational Site
Yamaguchi-shi, Yamaguchi, , Japan
Novo Nordisk Investigational Site
Yamato-shi, Kanagawa, , Japan
Countries
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References
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Kaku K, Araki E, Tanizawa Y, Ross Agner B, Nishida T, Ranthe M, Inagaki N. Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naive Japanese patients with type 2 diabetes in a phase 3, open-label, randomized trial. Diabetes Obes Metab. 2019 Dec;21(12):2674-2683. doi: 10.1111/dom.13856. Epub 2019 Aug 28.
Komatsu M, Watada H, Kaneko S, Ross Agner BF, Nishida T, Kaku K. Efficacy and safety of the fixed-ratio combination of insulin degludec and liraglutide by baseline glycated hemoglobin, body mass index and age in Japanese individuals with type 2 diabetes: A subgroup analysis of two phase III trials. J Diabetes Investig. 2021 Sep;12(9):1610-1618. doi: 10.1111/jdi.13525. Epub 2021 Mar 24.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1170-1332
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-153089
Identifier Type: OTHER
Identifier Source: secondary_id
NN9068-4183
Identifier Type: -
Identifier Source: org_study_id
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