Sodium-glucose co-transporter-2 inhibitor use and dietary carbohydrate intake in Japanese individuals with type 2 diabetes: A randomized, open-label, 3-arm parallel comparative, exploratory study

Diabetes Obes Metab. 2017 May;19(5):739-743. doi: 10.1111/dom.12848. Epub 2017 Feb 21.

Abstract

This study investigated the safety and efficacy of the sodium-glucose co-transporter-2 (SGLT2) inhibitor luseogliflozin with differing carbohydrate intakes in Japanese individuals with type 2 diabetes (T2D). Participants were randomly assigned to 3 carbohydrate-adjusted meals for 14 days (days 1-14; a high carbohydrate [HC; 55% total energy carbohydrate] and high glycaemic index [HGI] meal; an HC [55% total energy carbohydrate] and low glycaemic index [LGI] meal; or a low carbohydrate [LC; 40% total energy carbohydrate] and HGI meal). All participants received luseogliflozin for the last 7 days (days 8-14), continuous glucose monitoring (CGM) before and after luseogliflozin treatment (days 5-8 and days 12-15) and blood tests on days 1, 8 and 15. Luseogliflozin significantly decreased the area under the curve and mean of CGM values in all 3 groups similarly. Fasting plasma glucose, insulin and glucagon were similar at all time points. Ketone bodies on day 15 were significantly higher in the LC-HGI group compared with the HC-HGI and HC-LGI groups. In conclusion, luseogliflozin has similar efficacy and safety in Japanese people with T2D when meals contain 40% to 55% total energy carbohydrate, but a strict LC diet on this class of drug should be avoided to prevent SGLT2 inhibitor-associated diabetic ketoacidosis.

Keywords: SGLT2 inhibitor; carbohydrate intake; continuous glucose monitoring; glucose variability; glycaemic index; luseogliflozin; type 2 diabetes.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Blood Glucose / analysis
  • Combined Modality Therapy
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / diet therapy
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / metabolism
  • Diabetic Ketoacidosis / etiology
  • Diabetic Ketoacidosis / prevention & control
  • Diet, Carbohydrate-Restricted / adverse effects
  • Diet, Diabetic / methods*
  • Dietary Carbohydrates / administration & dosage*
  • Dietary Carbohydrates / metabolism
  • Female
  • Glycated Hemoglobin A / analysis
  • Glycemic Index
  • Humans
  • Hyperglycemia / prevention & control
  • Hypoglycemia / prevention & control
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Japan
  • Ketone Bodies / blood
  • Male
  • Membrane Transport Modulators / adverse effects
  • Membrane Transport Modulators / therapeutic use*
  • Middle Aged
  • Monitoring, Physiologic
  • Sodium-Glucose Transporter 2 / metabolism
  • Sodium-Glucose Transporter 2 Inhibitors*
  • Sorbitol / adverse effects
  • Sorbitol / analogs & derivatives*
  • Sorbitol / therapeutic use

Substances

  • Blood Glucose
  • Dietary Carbohydrates
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Ketone Bodies
  • Membrane Transport Modulators
  • Sodium-Glucose Transporter 2
  • Sodium-Glucose Transporter 2 Inhibitors
  • hemoglobin A1c protein, human
  • Sorbitol
  • 1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol