Abstract | 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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Authors | Fukumi Yoshikawa, Naoki Kumashiro, Fumika Shigiyama, Hiroshi Uchino, Yasuyo Ando, Hiroshi Yoshino, Masahiko Miyagi, Kayoko Ikehara, Takahisa Hirose |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 21
Issue 2
Pg. 303-311
(02 2019)
ISSN: 1463-1326 [Electronic] England |
PMID | 30187632
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | © 2018 John Wiley & Sons Ltd. |
Chemical References |
- Benzhydryl Compounds
- Blood Glucose
- Glucosides
- Glycated Hemoglobin A
- empagliflozin
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Topics |
- Adult
- Aged
- Benzhydryl Compounds
(administration & dosage)
- Blood Glucose
(drug effects, metabolism)
- Diabetes Mellitus, Type 2
(blood, diet therapy, drug therapy)
- Diet
- Double-Blind Method
- Drug Administration Schedule
- Energy Intake
(physiology)
- Female
- Glucosides
(administration & dosage)
- Glycated Hemoglobin
(drug effects, metabolism)
- Humans
- Japan
- Male
- Middle Aged
- Self-Management
(methods)
- Treatment Outcome
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