TY - JOUR
T1 - Efficacy of intermittent empagliflozin supplementation on dietary self-management and glycaemic control in patients with poorly controlled type 2 diabetes
T2 - A 24-week randomized controlled trial
AU - Yoshikawa, Fukumi
AU - Kumashiro, Naoki
AU - Shigiyama, Fumika
AU - Uchino, Hiroshi
AU - Ando, Yasuyo
AU - Yoshino, Hiroshi
AU - Miyagi, Masahiko
AU - Ikehara, Kayoko
AU - Hirose, Takahisa
N1 - Funding Information:
We thank Hirokazu Yamada, Soiken Holdings Inc., Tokyo, Japan, for the excellent assistance with statistical analysis.
Funding Information:
N. K. has received lecture fees from Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH and Takeda Pharmaceutical Company Limited. T.H. has received research funds from AstraZeneca, Boehringer Ingel-heim Pharmaceuticals, Inc., Astellas Pharma Inc., Ono Pharmaceutical Co., Ltd, Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH, Daiichi-Sankyo Co., Ltd, Eli Lilly Japan K.K., Takeda Pharmaceutical Company Limited, Mitsubishi Tanabe Pharma Corporation, Dainippon Sumitomo Pharma Co., Ltd, Kissei Pharmaceutical Co., Ltd and Johnson & Johnson, and received lecture fees from Sanofi-Aventis Deutschland GmbH, Eli Lilly Japan K.K., Novo Nordisk Inc, Takeda Pharmaceutical Company Ltd, Daiichi-Sankyo Co., Ltd, Mitsubishi Tanabe Pharma Corporation, Merck & Co., Inc, Dainippon Sumitomo Pharma Co., Ltd, Novartis Pharma K.K., Kissei Pharmaceutical Co., Ltd, Boehringer Ingelheim Pharmaceuticals, Inc., Ono Pharmaceutical Co., Ltd and AstraZeneca. The funding agencies had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2018 John Wiley & Sons Ltd
PY - 2019/2
Y1 - 2019/2
N2 - Aims: To explore the effects of intermittent use of empagliflozin, a sodium-glucose co-transporter-2 inhibitor, on dietary self-management and glycaemic control in patients with inadequately controlled type 2 diabetes. Materials and methods: We conducted a prospective, randomized, open-label, blinded-endpoint, parallel-group, comparative clinical trial of 50 patients with type 2 diabetes, treated with no more than three oral antidiabetic drugs (glycated haemoglobin [HbA1c] ≥52 mmol/mol but <86 mmol/mol). The participants were randomized to take 10 mg/d empagliflozin either every day (regular group, n = 25) or on the day on which they considered they had overeaten (intermittent group, n = 25) for 24 weeks. We limited empagliflozin prescription to half of the required period in the intermittent group. The primary endpoint was change in HbA1c at the end of the 24-week treatment period relative to baseline. The secondary outcomes included changes in body weight, daily energy intake and diabetes treatment-related quality of life (QoL). Energy intake was assessed using a diet-specific validated questionnaire rather than actual assessments of food intake. Results: The intake rate of empagliflozin was 96.7 ± 7.2% for the regular group and 45.7 ± 7.0% for the intermittent group. Interestingly, ΔHbA1c was identical in the two groups (−0.64 ± 0.19% and − 0.65 ± 0.17%, respectively). Body weight decreased (−2.72 ± 0.52 and − 1.50 ± 0.45 kg, respectively) and diabetes treatment-related QoL increased significantly from baseline in both groups. Energy intake, however, decreased significantly only in the intermittent group (−221.0 ± 108.3 kcal/d). Conclusions: Intermittent empagliflozin supplementation is a useful therapeutic option that empowers dietary self-management, improves glycaemic control and is accompanied by body weight loss and an increase in diabetes treatment-related QoL in patients with inadequately controlled type 2 diabetes.
AB - Aims: To explore the effects of intermittent use of empagliflozin, a sodium-glucose co-transporter-2 inhibitor, on dietary self-management and glycaemic control in patients with inadequately controlled type 2 diabetes. Materials and methods: We conducted a prospective, randomized, open-label, blinded-endpoint, parallel-group, comparative clinical trial of 50 patients with type 2 diabetes, treated with no more than three oral antidiabetic drugs (glycated haemoglobin [HbA1c] ≥52 mmol/mol but <86 mmol/mol). The participants were randomized to take 10 mg/d empagliflozin either every day (regular group, n = 25) or on the day on which they considered they had overeaten (intermittent group, n = 25) for 24 weeks. We limited empagliflozin prescription to half of the required period in the intermittent group. The primary endpoint was change in HbA1c at the end of the 24-week treatment period relative to baseline. The secondary outcomes included changes in body weight, daily energy intake and diabetes treatment-related quality of life (QoL). Energy intake was assessed using a diet-specific validated questionnaire rather than actual assessments of food intake. Results: The intake rate of empagliflozin was 96.7 ± 7.2% for the regular group and 45.7 ± 7.0% for the intermittent group. Interestingly, ΔHbA1c was identical in the two groups (−0.64 ± 0.19% and − 0.65 ± 0.17%, respectively). Body weight decreased (−2.72 ± 0.52 and − 1.50 ± 0.45 kg, respectively) and diabetes treatment-related QoL increased significantly from baseline in both groups. Energy intake, however, decreased significantly only in the intermittent group (−221.0 ± 108.3 kcal/d). Conclusions: Intermittent empagliflozin supplementation is a useful therapeutic option that empowers dietary self-management, improves glycaemic control and is accompanied by body weight loss and an increase in diabetes treatment-related QoL in patients with inadequately controlled type 2 diabetes.
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U2 - 10.1111/dom.13524
DO - 10.1111/dom.13524
M3 - Article
C2 - 30187632
AN - SCOPUS:85054514800
VL - 21
SP - 303
EP - 311
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
SN - 1462-8902
IS - 2
ER -