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Effects of Ipragliflozin on Postprandial Glucose

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Effects of Ipragliflozin on Postprandial Glucose Diabetes Ther https://doi.org/10.1007/s13300-018-0366-8 BRIEF REPORT Effects of Ipragliflozin on Postprandial Glucose Metabolism and Gut Peptides in Type 2 Diabetes: A Pilot Study Hiroaki Ueno . Hiroko Nakazato . Emi Ebihara . Kenji Noma . Takahisa Kawano . Kazuhiro Nagamine . Hideyuki Sakoda . Masamitsu Nakazato Received: November 10, 2017 Ó The Author(s) 2018. This article is an open access publication ABSTRACT were measured before and 12 weeks after ipra- gliflozin treatment. Introduction: Ipragliflozin is a novel antidia- Results: Body weight, body fat mass, systolic betic drug that inhibits renal tubular sodium- blood pressure, and HbA1c and serum uric acid glucose cotransporter-2 (SGLT2). The aim of levels were significantly decreased after the this study was to evaluate the effects of ipragli- treatment. Postprandial glucose and insulin flozin on glucose, insulin, glucagon, and gas- levels were also significantly decreased. Post- trointestinal peptide responses to a meal prandial glucagon increased both before and tolerance test, as well as to investigate the glu- after ipragliflozin treatment; however, the cose-lowering mechanisms of ipragliflozin. increment tended to be smaller after treatment. Methods: Nine Japanese patients with obesity Active GLP-1, active GIP, ghrelin, and des-acyl and type 2 diabetes mellitus were treated with ghrelin did not change after treatment. ipragliflozin (50 mg/day) for 12 weeks. The Conclusion: Ipragliflozin improved glycemic postprandial profiles of glucose, insulin, gluca- control by reducing body weight, postprandial gon, active glucagon-like peptide-1 (GLP-1), inappropriate glucagon secretion, and the active glucose-dependent insulinotropic postprandial insulin requirement. Although polypeptide (GIP), ghrelin, and des-acyl ghrelin this was a short-term study with a small sample size, ipragliflozin may offer benefits for patients with obesity and type 2 diabetes mellitus. Trial Registration: University Hospital Medical Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ Information Network (UMIN No. 000017195). A02DF060212BE85F. Keywords: Ghrelin; GLP-1; Glucagon; H. Ueno (&) Á H. Nakazato Á E. Ebihara Á Ipragliflozin; Type 2 diabetes mellitus K. Nagamine Á H. Sakoda Á M. Nakazato Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, INTRODUCTION Miyazaki, Japan e-mail: [email protected] Individuals with obesity are at high risk of K. Noma developing diabetes mellitus. In addition, after Noma Naika Clinic, Miyazaki, Japan developing diabetes mellitus, their glycemic control easily worsens. T. Kawano Kawano Naika Clinic, Miyazaki, Japan Diabetes Ther These individuals are more likely to develop metabolism and gastrointestinal hormones, complications such as dyslipidemia, hyperten- including glucagon-like peptide-1 (GLP-1), glu- sion, and hepatic steatosis. Conversely, when cose-dependent insulinotropic polypeptide obese diabetic patients lose 3–5% or more of (GIP), glucagon, ghrelin, and des-acyl ghrelin. their weight, they benefit from improvements in these complications [1]. Developed countries have an overabun- METHODS dance of inexpensive, high-calorie foods and advanced transportation systems; thus, indi- Subjects viduals living in these countries may have dif- ficulty reducing their energy consumption and We conducted an open-label study to investi- adhering to lifestyle changes to their diets or gate the effects of 50 mg/day of ipragliflozin in exercise therapy. patients with type 2 diabetes mellitus. The Sodium-glucose cotransporter-2 (SGLT2) patients ranged in age from 20 to 70 years, with inhibitors suppress the activity of SGLT2 HbA1c levels between 6.0% and 9.0%. The expressed in renal tubules and increase urinary patients were recruited between August 2015 glucose excretion, thereby improving blood and October 2016 from three study sites: glucose levels [2]. In Japan, SGLT2 inhibitors Miyazaki University Hospital, Noma Naika became available in 2015; in most obese dia- clinic, and Kawano Naika clinic. We excluded betic patients, these drugs help to decrease body patients with any of the following conditions: weight and improve HbA1c levels [3]. A double- patients with an estimated glomerular filtration blind comparative study of an SGLT2 inhibitor, rate of 45 mL/min/1.73 m2, patients with severe empagliflozin, in diabetic patients (including hepatic function disorders or malignant tumors, Asian patients) who were at high risk of car- patients with severe microvascular or diovascular events showed that empagliflozin macrovascular complications, pregnant significantly reduced total mortality and the patients, patients already receiving oral admin- incidence of cardiovascular events [4–6]. istration of SGLT2 inhibitors, patients with The mechanisms underlying the weight loss allergies to SGLT2 inhibitors, and patients and reduction of plasma glucose level using receiving insulin or GLP-1 receptor agonists. Of SGLT2 inhibitors are believed to occur through the 11 patients who were enrolled in the study, loss of glucose in the urine. However, it is possible nine patients (seven men and two women) were that these medications may work through other included in the analysis; the two excluded mechanisms such as gastrointestinal peptides patients dropped out voluntarily. Patient char- and glucagon. The effects of SGLT2 inhibitors on acteristics are shown in Table 1. gastrointestinal peptides and glucagon in dia- betic patients are not fully clarified. We hypoth- Study Protocol esized that ipragliflozin may affect the secretion of gastrointestinal peptides and glucagon to All patients provided written consent for par- improve plasma glucose levels and to reduce ticipation in this study. We instructed them to body weight, at least in part. Therefore, we visit Miyazaki University Hospital after fasting examined the glucose metabolism as well as for at least 10 h and measured their height, gastrointestinal peptides before and after ipra- weight, body composition (InBody 720; InBody gliflozin treatment in this study. This study Japan Inc.), blood pressure, and pulse rate. aimed to investigate the effects of an SGLT2 Subsequently, MTTs (426 kcal; carbohydrates inhibitor, ipragliflozin, including its effects on 59.7%; protein 9.5%; lipids 30.7%) were per- glucose metabolism. Ipragliflozin was adminis- formed. Blood samples were taken at 0 (base- tered for 12 weeks to nine patients with obesity line), 15, 30, 45, 60, 90, 120, and 180 min and type 2 diabetes mellitus. Meal tolerance tests postprandial; blood glucose, insulin, glucagon, (MTTs) were performed before and after ipragli- active GLP-1, active GIP, ghrelin, and des-acyl flozin administration to study changes in glucose Diabetes Ther Table 1 Baseline characteristics of subjects Japan), respectively. To measure ghrelin and des-acyl ghrelin levels, blood was collected Characteristics Value directly into tubes containing aprotinin; the Age (years) 50.0 ± 8.0 tubes were immediately centrifuged for plasma isolation at 4 °C. The isolated plasma was trea- Sex (men/women) 7/2 ted with one-tenth of its volume of 1 N HCl and 2 Body mass index (kg/m ) 29.8 ± 4.4 the tubes were rocked gently. These samples HbA1c (%) 7.2 ± 0.6 were then used for plasma ghrelin and des-acyl ghrelin measurements using an automated Fasting blood glucose (mg/dL) 139.9 ± 17.7 enzyme immunoassay (AIA-600II, Tosoh Cor- Duration of T2DM (year) 4.9 ± 4.7 poration, Japan) as described elsewhere [7]. Baseline levels of serum lipids, liver functions, Hypertension/dyslipidemia 3/7 renal functions, malondialdehyde (MDA)-mod- Treatment ified low-density lipoprotein (LDL) as oxidized LDL, 8-hydroxy-20-deoxyguanosine (8-OHdG) Diet only 4 as a marker of oxidative stress, high-sensitivity Metformin 5 C-reactive protein (hs-CRP) as an inflammatory marker, adiponectin, and leptin were measured DPP-4 inhibitors 3 (SRL Inc., Japan). The day after MTT, patients Sulfonylureas 1 started to receive 50 mg of ipragliflozin (once Pioglitazone 1 daily in the morning) concurrently with the oral drugs they had been receiving prior to the Number of oral hypoglycemic drugs 1/2/3 1/3/1 tests; the patients continued to make outpatient T2DM type 2 diabetes mellitus, DPP-4 dipeptidyl pepti- visits. MTTs were performed again 12 weeks dase-4 after ipragliflozin administration. This study was approved by the Ethics Review Committee of the University of Miya- zaki and is registered in the University Hospital ghrelin levels were measured at all blood sam- Medical Information Network Clinical Trials pling times. Blood glucose and insulin levels Registry as UMIN000017195. All procedures were measured with a hexokinase assay and a followed were in accordance with the ethical chemiluminescent enzyme immunoassay (SRL standards of the responsible committee on Inc., Japan), respectively. For measurements of human experimentation (institutional and blood active GLP-1, active GIP, and glucagon, national) and with the Helsinki Declaration of blood was collected using P-800 blood collec- 1964, as revised in 2013. tion tubes (Japan Becton, Dickinson and Com- pany, Japan); the tubes were centrifuged for Statistical Analysis 15 min at 3000 rpm and 4 °C to isolate plasma. The samples for glucagon measurements were All results are presented as mean ± standard immediately placed in a freezer at - 70 °C, then deviation. Statistical analysis was performed by glucagon levels were measured by a sandwich
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