Efficacy of intermittent empagliflozin supplementation on dietary self‐management and glycaemic control in patients with poorly controlled type 2 diabetes: A 24‐week randomized controlled trial

• Published in: Diabetes, obesity & metabolism Vol. 21; no. 2; pp. 303 - 311
• Main Authors: Yoshikawa, Fukumi, Kumashiro, Naoki, Shigiyama, Fumika, Uchino, Hiroshi, Ando, Yasuyo, Yoshino, Hiroshi, Miyagi, Masahiko, Ikehara, Kayoko, Hirose, Takahisa
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-02-2019; Wiley Subscription Services, Inc
• Subjects: Antidiabetics; Body weight; Body weight loss; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Dietary supplements; empagliflozin; Energy intake; Evidence-based medicine; Food intake; Glucose transporter; Hemoglobin; intermittent use; Management; Patients; Quality of life; self‐management; Sodium; empagliflozin; intermittent use; self-management
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.13524

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.