Diabetes, obesity & metabolismJan 12, 2018

Safety and effectiveness of weekly semaglutide compared to extra oral diabetes medicines in Japanese people with poorly controlled type 2 diabetes

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Updated Mar 31, 2026

Abstract

88.0% of participants receiving semaglutide reported adverse events, compared to 71.7% with an additional oral antidiabetic drug.

Semaglutide 0.5 mg and 1.0 mg significantly reduced mean glycated hemoglobin (HbA1c) by 1.7% and 2.0%, respectively, compared to a 0.7% reduction with the additional oral antidiabetic drug.
Body weight decreased by 1.4 kg and 3.2 kg in the semaglutide groups, while participants receiving the additional oral antidiabetic drug experienced a 0.4-kg weight increase.
More than 80% of semaglutide-treated participants achieved an HbA1c concentration below 7.0%, meeting the target set by the Japanese Diabetes Society.
Gastrointestinal adverse events were the most frequent in semaglutide groups but typically mild or moderate and diminished over time.
No new safety issues were identified with semaglutide treatment.

Simplified

AIM: To evaluate the safety and efficacy of once-weekly subcutaneous semaglutide as monotherapy or combined with an oral antidiabetic drug (OAD) vs an additional OAD added to background therapy in Japanese people with type 2 diabetes (T2D) inadequately controlled on diet/exercise or OAD monotherapy.

METHODS: In this phase III, open-label trial, adults with T2D were randomized 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (a dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with a different mode of action from that of background therapy. The primary endpoint was number of adverse events (AEs) after 56 weeks.

RESULTS: Baseline characteristics were balanced between treatment arms (601 randomized). More AEs were reported in the semaglutide 0.5 mg (86.2%) and 1.0 mg (88.0%) groups than in the additional OAD group (71.7%). These were typically mild/moderate. Gastrointestinal AEs were most frequent with semaglutide, which diminished over time. The mean glycated haemoglobin (HbA1c) concentration (baseline 8.1%) was significantly reduced with semaglutide 0.5 mg and 1.0 mg vs additional OAD (1.7% and 2.0% vs 0.7%, respectively; estimated treatment difference [ETD] vs additional OAD -1.08% and -1.37%, both P < .0001). Body weight (baseline 71.5 kg) was reduced by 1.4 kg and 3.2 kg with semaglutide 0.5 mg and 1.0 mg, vs a 0.4-kg increase with additional OAD (ETD -1.84 kg and -3.59 kg; both P < .0001). For semaglutide-treated participants, >80% achieved an HbA1c concentration <7.0% (Japanese Diabetes Society target).

CONCLUSIONS: Semaglutide was well tolerated, with no new safety issues identified. Semaglutide treatment significantly reduced HbA1c and body weight vs additional OAD treatment in Japanese people with T2D.

Key numbers

1.7%

Reduction in HbA1c

Change in HbA1c with semaglutide 0.5 mg vs additional OAD

3.2 kg

Body weight change

Mean weight change with semaglutide 1.0 mg vs additional OAD

88.0%

Adverse events incidence

Proportion of participants reporting TEAEs with semaglutide 1.0 mg

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Competing interests

K.K. has received honoraria or consulting fees from Astellas Pharma, AstraZeneca KK, MSD KK, Ono Pharmaceutical, Kissei Pharmaceutical, Kowa Pharmaceutical, Sanofi KK, Sanwakagaku Kenkyusyo, Sumitomo Dainippon Pharma, Mitsubishi Tanabe Pharma, Novartis Pharma KK, Novo Nordisk, Nippon Boehringer Ingelheim, Taisho Toyama Pharmaceutical and Takeda, and research grants from Taisho Pharmaceutical, Mitsubishi Tanabe Pharma and Nippon Boehringer Ingelheim. Y.Y. has received honoraria or consulting fees from Novo Nordisk. H.W. has received honoraria for consulting from Boehringer Ingelheim, Daiichi Sankyo, Dainippon Sumitomo Pharma, Eli Lilly, Kowa Pharmaceutical, Merck Sharp & Dohme, Novo Nordisk, Novartis, Ono Pharmaceutical, Sanofi, Sanwa Kagaku Kenkyusho, Takeda, Astellas Pharma, Mitsubishi Tanabe Pharma, AstraZeneca, Kyowa Hakko Kirin and Kissei Pharmaceutical, and grants from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Dainippon Sumitomo Pharma, Eli Lilly, Kissei Pharma, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Novartis, Novo Nordisk, Pfizer, Sanofi, Sanwakagaku Kenkyusho, Takeda, Terumo Corp, Novartis, Astellas Pharma, Abbott Japan, Ono Pharmaceutical, Kyowa Hakko Kirin Co. Ltd, Kowa Pharmaceutical, Johnson & Johnson, Taisho Toyama Pharmaceutical, Nitto Boseki Company, Bayer, Bristol‐Myers Squibb and Benefit one Health care. A.A. has received consulting and/or speaker fees from Novo Nordisk, Eli Lilly Japan, Nippon Boehringer Ingelheim, Kowa Pharmaceutical, Novartis International, Astellas Pharma, Mitsubishi Tanabe Pharma, Taisho Toyama Pharmaceutical, Kyowa Hakko Kirin, Sumitomo Dainippon Pharma, Sanofi, MSD, Takeda, AstraZeneca, Ono Pharmaceutical, Sanwa Kagaku Kenkyusho and Daiichi Sankyo, and research grants from Novo Nordisk. T.N. is an employee of Novo Nordisk and holds shares in the company. J.Z. is an employee of Novo Nordisk and holds shares in the company. A.K. has received honoraria and consultation fees from AstraZeneca.

PubMed

Safety and effectiveness of weekly semaglutide compared to extra oral diabetes medicines in Japanese people with poorly controlled type 2 diabetes

Abstract

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Competing interests

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Abstract

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