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. 2016 Jan 14;7(3):299-307.
doi: 10.1007/s13340-015-0250-y. eCollection 2016 Sep.

Efficacy and safety assessment of basal supported oral therapy (BOT) with insulin glargine in a real-life clinical setting, stratified by concomitant orally administered antidiabetic agent (OAD) regimens including dipeptidyl peptidase-4 inhibitor (DPP-4i): subanalysis of the ALOHA2 study, drug-use surveillance in Japan

Shoko Tsukube  1 , Takashi Kadowaki  2 , Masato Odawara  3
Affiliations

Efficacy and safety assessment of basal supported oral therapy (BOT) with insulin glargine in a real-life clinical setting, stratified by concomitant orally administered antidiabetic agent (OAD) regimens including dipeptidyl peptidase-4 inhibitor (DPP-4i): subanalysis of the ALOHA2 study, drug-use surveillance in Japan

Shoko Tsukube et al. Diabetol Int. .

Abstract

Aims and introduction: We aimed to explore concomitant orally administered antidiabetic agent (OAD) regimens used in basal supported oral therapy (BOT) with insulin glargine in a real-life setting, and to assess the efficacy and safety of each regimen using data from the Add-on Lantus® to Oral Hypoglycemic Agents 2 study, a 24-week observational study in Japanese type 2 diabetes patients.

Materials and methods: Among 1629 insulin-naïve patients who had a glycosylated hemoglobin (HbA1c) value of ≥6.5 % during the previous 4 weeks and were treated with BOT during the observational period, 1227 patients who retained the same concomitant OAD regimens throughout the period were included in the analysis.

Results: Sulfonylurea (71.5 %), dipeptidyl peptidase-4 inhibitor (DPP-4i; 60.7 %), and biguanide (BG; 48.6 %) were commonly administered OADs in BOT. The HbA1c level decreased in patients taking BG alone (-2.76 %) and DPP-4i alone (-2.46 %). Of the three OADs, mean doses of the most frequently administered OAD changed from baseline to the final evaluation point: 2.5-2.3 mg for glimepiride, 59.1-58.7 mg for sitagliptin, and 1145.6-1168.2 mg for metformin. No significant difference in the hypoglycemia incidence rate was found between regimens (p = 0.3765), with incidence rates of 1.9 % (DPP-4i alone) to 7.0 % (other regimens) observed.

Conclusions: DPP-4i plays a major role in BOT with insulin glargine in a real-life setting. The incidence of hypoglycemia did not differ significantly between BOT regimens, including DPP-4i. Insulin glargine added to DPP-4i is a potential therapeutic approach.

Keywords: Basal supported oral therapy; Dipeptidyl peptidase-4 inhibitors; Insulin glargine; Real-life observational study; Type 2 diabetes.

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Conflict of interest statement

Insulin glargine is marketed by Sanofi K.K. under the name Lantus®. Shoko Tsukube is an employee of Sanofi K.K., Tokyo, Japan. Takashi Kadowaki has served on advisory panels for Boehringer Ingelheim, Daiichi Sankyo, Novo Nordisk, Taisho, Takeda, and Mitsubishi Tanabe; has served as a consultant for Boehringer Ingelheim and MSD; has received research support from Astra Zeneca, Chugai, Daiichi Sankyo, MSD, Ono, Sanofi, Takeda, and Mitsubishi Tanabe; and has served on speakers’ bureaus for Astellas, Astra Zeneca, Boehringer Ingelheim, Daiichi Sankyo, Sumitomo Dainippon, Eli Lilly, Kowa, Kyowa Hakko Kirin, MSD, Novartis, Ono, Sanofi, Sanwa, Taisho, Takeda, and Mitsubishi Tanabe. Masato Odawara has served on advisory panels for Astra Zeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Taisho; has received research support from Astellas, Astra Zeneca, Boehringer Ingelheim, Daiichi Sankyo, Sumitomo Dainippon, Eli Lilly, Kowa, Kyowa Hakko Kirin, MSD, Novartis, Ono, Sanofi, Taisho, Takeda, and Mitsubishi Tanabe; and has served on speakers’ bureaus for Astellas, Astra Zeneca, Boehringer Ingelheim, Daiichi Sankyo, Sumitomo Dainippon, Eli Lilly, Kowa, Kyowa Hakko Kirin, MSD, Novartis, Ono, Sanofi, Taisho, Takeda, and Mitsubishi Tanabe.This study was conducted as special drug use surveillance, and complied with the pharmaceutical affairs law enacted by the Health Authority in Japan and the ministerial ordinance of Good Post-marketing Study Practice (GPSP) in Japan. It was conducted after a contract had been signed with each medical institution that participated in the survey. Informed consent or a substitute for it was obtained from all patients before they were included in the ALOHA2 study.

Figures

Fig. 1
Fig. 1
Patient disposition. aPatients who had received insulin glargine at least once, bpatients who had never been treated with insulin previously and who were treated with BOT throughout the observational period. CRF case report form, HbA1c glycosylated hemoglobin, OAD orally administered antidiabetic agent, BOT basal supported oral therapy
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