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ABSTRACT
Background: The efficacy and safety of SGLT-2 and DPP-4 inhibitor monotherapies in T2DM is well established; however, data on the effect of combination therapies and sequence of administration are lacking. We investigated the efficacy and safety of the sequence of SGLT-2 and DPP-4 inhibitor administration in Japanese T2DM patients.
Research design and methods: In this single-institution, open-label, randomized controlled study, T2DM patients inadequately controlled (HbA1c ≥6.5%) with conventional therapy were randomized to receive luseogliflozin-sitagliptin (LS; luseogliflozin 2.5 mg for 0–12 weeks, then luseogliflozin plus sitagliptin 50 mg for 12–24 weeks) or sitagliptin-luseogliflozin (SL; sitagliptin 50 mg for 0–12 weeks, then sitagliptin plus luseogliflozin 2.5 mg for 12–24 weeks). The main outcome was the difference in mean change in HbA1c at 24 weeks relative to baseline between both groups.
Results: Of the 41 enrolled and randomized patients, 34 completed the study. Mean ± SD HbA1c at baseline was 10.35 ± 1.04% and 10.02 ± 1.40% in the LS and SL groups, respectively, and mean ± SD change in HbA1c at 24 weeks from baseline was −3.81 ± 1.21% vs −2.46 ± 1.42% (P < 0.01), respectively. No drug-related adverse events were reported.
Conclusion: Over the 24-week period, LS was more effective in reducing HbA1c levels than SL in Japanese T2DM patients.
Acknowledgments
Editorial assistance for the preparation of this manuscript was utilized in this manuscript and was provided by Cactus Communications and funded by Taisho Toyama Pharmaceutical Co., Ltd. This trial is registered at the UMIN Clinical Trials Registry (Identifier: UMIN000021658) (http://www.umin.ac.jp/english/).
Author contributions
Both authors were involved in the conception and design of the study; analysis and interpretation of the data; and drafting of the paper or revising it critically for intellectual content and the final approval of the version to be published. Both authors agree to be accountable for all aspects of the work.
Declaration of interest
The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit. M Takihata has received honoraria for lectures from Astellas Pharma Inc., Merck Sharp and Dohme, AstraZeneca, Ono Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Kowa Pharmaceutical Co., Ltd., Sanofi Aventis, Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly Japan, Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., Novartis Pharma, Chugai Pharmaceutical Co., Ltd., and Terumo Corporation as well as unrestricted grants from Astellas Pharma Inc., Merck Sharp and Dohme, AstraZeneca, Ono Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co., Ltd., Sanofi Aventis, Sumitomo Dainippon Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly Japan, Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., Fujiyakuhin Co., Ltd., and Terumo Corporation.
Y Terauchi has received honoraria for lectures from Astellas Pharma Inc., Merck Sharp and Dohme, AstraZeneca, Ono Pharmaceutical Co., Ltd., Sanwa Kagaku Kenkyusho Co., Ltd., Bayer Yakuhin, Ltd., Kissei Pharmaceutical Co., Ltd., Pfizer, Kyowa Hakko Kirin Co., Ltd., Kowa Pharmaceutical Co., Ltd., Sanofi Aventis, Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly Japan, Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., Novartis Pharma, Chugai Pharmaceutical Co., Ltd., Teijin, Mochida Pharmaceutical Co., Ltd., Roche Diagnostics, and Johnson & Johnson and unrestricted grants from Merck Sharp and Dohme, Ono Pharmaceutical Co., Ltd., Sanwa Kagaku Kenkyusho Co., Ltd., Bayer Yakuhin, Ltd., Kissei Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co., Ltd., Sanofi Aventis, Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly Japan, Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., and Novartis Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Correction Statement
This article has been republished with minor changes. These changes do not impact the academic content of the article.