Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes
NCT ID: NCT03015220
Last Updated: 2021-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
458 participants
INTERVENTIONAL
2017-01-10
2018-07-12
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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Oral semaglutide 3 mg
Semaglutide
Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).
Oral semaglutide 7 mg
Semaglutide
Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).
Oral semaglutide 14 mg
Semaglutide
Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).
Dulaglutide 0.75 mg
Dulaglutide
Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).
Interventions
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Semaglutide
Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).
Dulaglutide
Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).
Eligibility Criteria
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Inclusion Criteria
* Japanese male or female, age above or equal to 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening
* HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive)
* OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling
Exclusion Criteria
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack (TIA) within the past 180 days prior to the day of screening and randomisation
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)
* Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
* Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening
* For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening
* Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 14 days
* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in situ carcinomas)
* History of diabetic ketoacidosis
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
Annaka-shi, Gunma, , Japan
Novo Nordisk Investigational Site
Arakawa-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Chiba-shi, Chiba, , Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Fukushima, , Japan
Novo Nordisk Investigational Site
Gunma, , Japan
Novo Nordisk Investigational Site
Ibaraki, , Japan
Novo Nordisk Investigational Site
Iruma-shi, Saitama, , Japan
Novo Nordisk Investigational Site
Kanagawa, , Japan
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Kawagoe-shi, Saitama, , Japan
Novo Nordisk Investigational Site
Kawaguchi-shi, Saitama, , Japan
Novo Nordisk Investigational Site
Kumamoto, , Japan
Novo Nordisk Investigational Site
Kurashiki-shi, Okayama, , Japan
Novo Nordisk Investigational Site
Kyoto-shi, Kyoto, , Japan
Novo Nordisk Investigational Site
Mitaka-shi, Tokyo, , Japan
Novo Nordisk Investigational Site
Mito-shi, Ibaraki, , Japan
Novo Nordisk Investigational Site
Miyazaki, , Japan
Novo Nordisk Investigational Site
Osaka, , Japan
Novo Nordisk Investigational Site
Ota-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Sapporo, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, , Japan
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, , Japan
Novo Nordisk Investigational Site
Shinagawa-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, , Japan
Novo Nordisk Investigational Site
Suita-shi, Osaka, , 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
Yamato-shi, Kanagawa, , Japan
Countries
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References
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Ishii H, Hansen BB, Langer J, Horio H. Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial. Diabetes Ther. 2021 Feb;12(2):613-623. doi: 10.1007/s13300-020-00985-w. Epub 2021 Jan 18.
Yabe D, Nakamura J, Kaneto H, Deenadayalan S, Navarria A, Gislum M, Inagaki N; PIONEER 10 Investigators. Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2020 May;8(5):392-406. doi: 10.1016/S2213-8587(20)30074-7.
Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.
Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1181-4133
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-173485
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-4282
Identifier Type: -
Identifier Source: org_study_id
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