Clinical trial NCT02207374: A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes
Official title: Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-08-04
Enrollment: 601
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy.

All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.


Eligibility criteria: Inclusion Criteria:

* Male or female, age at least 20 years at the time of signing informed consent
* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
* Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (week -2)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence \[not having sex\], diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
* Treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness
* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* History of chronic or idiopathic acute pancreatitis
* Screening calcitonin value above or equal to 50 ng/L (pg/mL)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
* Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
* Acute coronary or cerebrovascular event within 90 days before randomisation (Visit 2 \[week 0\])
* Heart failure, New York Heart Association (NYHA) class IV

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Weeks 0-56
Secondary outcomes:
measure: Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: Weeks 0-56
measure: Change in Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: Week 0, week 56
Other outcomes:
Locations:
city: Akita-shi, Akita
country: Japan
facility: Novo Nordisk Investigational Site
city: Annaka-shi, Gunma
country: Japan
facility: Novo Nordisk Investigational Site
city: Asahikawa-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Asahikawa-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Bunkyo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Higashiosaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Izumisano-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Kashiwara-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Katsushika-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Kitakyushu-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Koriyama-shi, Fukushima
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi,Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Kyoto-shi, Kyoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Mito-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Miyazaki-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Naka-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishinomiya-shi, Hygo
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishinomiya-shi, Hyogo
country: Japan
facility: Novo Nordisk Investigational Site
city: Okawa-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Okayama-shi, Okayama
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Oyama-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Saga-shi,Saga
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sendai-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Suita-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Takatsuki-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Ube-shi, Yamaguchi
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Diabetes Obes Metab. 2018 May;20(5):1202-1212. doi: 10.1111/dom.13218. Epub 2018 Feb 21.
citation: Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.
citation: Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
citation: 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.