bluuebunny/crossref_metadata_2025_split huggingface dataset:
ITCA 650 Provides Consistent Efficacy in T2D Irrespective of Baseline Characteristics—Results of a Pooled Subgroup Analysis
Authors: PRABHAKAR PRAKASH , KJEMS LISE L. , HUANG HOLLY , SCHWARTZ BRIAN , BARON MICHELLE A. 
Published: June 2018

ITCA 650 consists of a small titanium osmotic mini—pump that is subdermally placed in the abdominal wall during a brief in-office procedure. As an investigational product for the treatment of type 2 diabetes (T2D), ITCA 650 provides a continuous subcutaneous infusion of exenatide over 3 or 6 months. Pooled 39-week data from two double-blind, randomized, Phase 3 studies were used to evaluate the efficacy of ITCA 650 20/60 mcg/d in patients with T2D inadequately controlled by oral antidiabetic drugs (OADs). Results in the overall population (N=683) and in subgroups according to age, gender, BMI, ethnicity, time since diagnosis, baseline HbA1c, GI adverse events, presence of anti-drug antibodies, and renal function are reported. As shown in the Figure, the overall mean (standard deviation [SD]) reduction in HbA1c (%) was 1.5% (1.2) with clinically meaningful reductions in HbA1c consistently observed irrespective of age, gender, BMI, ethnicity, time from T2D diagnosis, eGFR and background OADs (data not shown). Patients with a higher baseline HbA1c had a greater response. Mean weight loss was 3.4 kg (SD 4.7), and 40.7% (95% CI 0.36-0.46) of patients achieved a composite endpoint of HbA1c/weight reduction of &gt;0.5%/≥2 kg. Similar changes were likewise seen consistently across subgroups. ITCA 650 demonstrated consistent efficacy across a wide spectrum of patients with T2D.

Disclosure
P. Prabhakar: None. L.L. Kjems: Employee; Self; Intarcia Therapeutics, Inc.. Stock/Shareholder; Self; Intarcia Therapeutics, Inc.. H. Huang: None. B. Schwartz: Employee; Self; Intarcia Therapeutics, Inc. M.A. Baron: Employee; Self; Intarcia Therapeutics, Inc..
Effect of Single Dose of Insulin Glargine/Lixisenatide Fixed-Ratio Combination (IGlarLixi) on Postprandial Glucodynamic Response in Japanese Patients with Type 2 Diabetes Mellitus
Authors: INOUE MEGUMI , LORENZ MARTIN , MUTO HIDEYA , HASHIMOTO YASUHIRO 
Published: June 2018

Fixed ratio combination of insulin glargine/lixisenatide (iGlarLixi) is expected to bring benefits such as better efficacy, mitigating barriers to their individual use, and convenient single daily injection. Based on the study results which demonstrated the efficacy and safety of iGlarLixi, approvals from FDA and EMA were obtained. Currently, specific clinical development of iGlarLixi in Japan is ongoing. A randomized, open-label, placebo-controlled, 4-sequence, 4-period, 4-treatment crossover study to investigate the postprandial glucodynamic response to single subcutaneously (SC) dose of iGlarLixi in Japanese T2DM patients was conducted. This study primary aimed at investigating the PD of lixisenatide at doses up to 10 μg in the combination with insulin glargine as compared to placebo and low-dose insulin glargine alone in Japanese T2DM patients. Twenty patients were assigned to one of the four sequences of treatments, all of which included iGlarLixi (5 U/5 μg and 10 U/10 μg), 5 U insulin glargine and placebo. The parameter PPG-AUC0-2h was evaluated as primary endpoint. The LS mean differences of PPG-AUC0-2h between iGlarLixi (5 U/5 μg) and placebo, iGlarLixi (10 U/10 μg) and placebo, iGlarLixi (10 U/10 μg) and iGlarLixi (5 U/5 μg), and iGlarLixi (5 U/5 μg) and 5U insulin glargine were -7.48 (p &lt; 0.0001), -10.75 (p &lt; 0.0001), -3.28 (p &lt; 0.0001), and -7.30 (p &lt; 0.0001), respectively. These results demonstrated the 2 doses of iGlarLixi significantly decreased PPG in a dose-dependent manner following a standardized breakfast when compared to placebo. And by combining the complementary therapeutic benefits of insulin glargine predominantly on FPG and the effect of lixisenatide on PPG, the combination product can affect both components of hyperglycemia as a therapeutic principle. No SAEs were reported and no patients discontinued the study. Single SC doses of iGlarLixi were safe and well tolerated.

Disclosure
M. Inoue: None. M. Lorenz: None. H. Muto: Employee; Self; Sanofi K.K. Y. Hashimoto: Employee; Self; Sanofi K.K..
In Vitro Studies to Evaluate the Receptor Kinetics of Efpeglenatide vs. Other Glucagon-Like Peptide-1 Receptor (GLP-1R) Agonists
Authors: CHOI IN YOUNG , MOON MI JIN , TRAUTMANN MICHAEL E. , HOMPESCH MARCUS , SORLI CHRISTOPHER H. 
Published: June 2018

Efpeglenatide (efpeg) is a long-acting GLP-1 R agonist in development for the treatment of T2D. Efpeg’s effects on the GLP-1 R suggest that it is a superagonist: a ligand that leads to greater maximal signaling and stimulation compared with its endogenous ligand. In vitro studies evaluated the superagonistic effects of efpeg and compared them to the effects of liraglutide (lira) and dulaglutide (dula) on GLP-1 R-binding kinetics and internalization, and cell signaling/desensitization. Efpeg had a higher dissociation constant vs. lira or dula (360.7 vs. 58.7 and 39.4 nmol/L, respectively) indicating a lower binding affinity for GLP-1 R (∼6.1 fold vs. lira, ∼9.2 vs. dula) and faster dissociation vs. lira (∼3.6 fold; p&lt;0.001) or dula (∼2.9 fold; p&lt;0.001). At 100nM, efpeg led to less receptor internalization vs. lira or dula (% of initial internalized receptor: 140% vs. 1191% and 714%, respectively; p&lt;0.001 each) and lower proportions of receptor lost from the cell surface (32% vs. 74% and 69%; p&lt;0.001). After pretreatment (4 or 24 h), efpeg led to significantly greater accumulation of cAMP and insulinotropic activity vs. lira or dula (Figure). The superagonistic effect of efpeg on GLP-1 R may be due to its specific binding characteristics, allowing more cell-surface receptor availability for intracellular signaling. The clinical relevance of these findings should be assessed further.

Disclosure
I. Choi: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. M. Moon: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. M.E. Trautmann: Consultant; Self; ProSciento. Stock/Shareholder; Self; Eli Lilly and Company. Consultant; Self; Hanmi Pharmaceutical, CeQur Corporation, Intarcia Therapeutics, Inc., Servier. M. Hompesch: Other Relationship; Self; Hanmi Pharmaceutical. C.H. Sorli: Employee; Self; Sanofi.
Bone Protective Effect of a Novel Long-Acting GLP-1/GIP/Glucagon Triple Agonist (HM15211) in an Animal Model
Authors: LEE SANGDON , KIM YU-YON , LEE JONG SUK , LEE SANG HYUN , KIM YOUNG HOON , CHOI IN YOUNG , KIM SUN JIN 
Published: June 2018

Severe weight loss is often associated with reduction of bone mineral density (BMD) and an imbalance between bone formation and reabsorption in obese people. As a consequence, there can be an increased risk of bone fractures with body weight loss. Several studies have proposed that the gut hormones, GIP and GLP-1, might be modulators of bone growth and remodeling. HM15211 is a novel long-acting GLP-1/GIP/Glucagon agonist that is being developed for the treatment of obesity. In this study, we investigated whether treatment with HM15211 prevents bone loss under a severe weight loss condition, and the underlying mechanism of action. First, the bone protective effect of HM15211 was evaluated using diet induced obesity ovariectomized osteoporosis rat model. After 4 weeks subcutaneous treatment of HM15211 (120 µg/kg/Q3D), lower levels of serum decarboxylated osteocalcin (42.2 ng/mL) and higher serum P1NP (procollagen type I pro-peptide, 53.2 ng/mL) were observed compared with those of vehicle- (156.4 ng/mL for osteocalcin, 28.6 ng/mL for PINP) and liraglutide-treated groups (94 µg/kg/BID, 120.6 ng/mL for osteocalcin, 29.4 ng/mL for PINP). Furthermore, HM15211 showed comparable BMD of femur bones and lumbar spine with vehicle group while weight loss was greater (-26.0% vs. vehicle) compared to liraglutide (-11.5% vs. vehicle). These results suggest that treatment with HM15211 effectively prevents bone loss even after potent body weight loss in high fat dieted ovariectomized obese rats. Second, to elucidate the underlying molecular mechanism, related marker gene expression was investigated using the SaOS2 cell, human osteogenic cell. In line with the bone protective effect in vivo, HM15211 led to significant increases in type 1 collagen-α1, -α2, and carboxylated osteocalcin expression, which were blunted by inhibition of GIPR-mediated signaling.
In conclusion, these results suggest that HM15211 might provide potent weight loss without the otherwise inevitable bone loss.

Disclosure
S. Lee: Employee; Self; Hanmi Pharmaceutical. Y. Kim: None. J. Lee: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. S. Lee: Employee; Self; Hanmi Pharmaceutical. Y. Kim: Employee; Self; Hanmi Pharmaceutical. I. Choi: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. S. Kim: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical.
Neuroprotective Effects of HM15211, a Novel Long-Acting GLP-1/GIP/Glucagon Triple Agonist in the Neurodegenerative Disease Models
Authors: KIM JEONG A. , LEE SANGDON , LEE SANG HYUN , JUNG SUNG YOUB , KIM YOUNG HOON , CHOI IN YOUNG , KIM SUN JIN 
Published: June 2018

HM15211 is a novel long-acting GLP-1/GIP/Glucagon triple agonist that is being developed for the treatment of obesity and nonalcoholic fatty liver disease (NASH). Accumulating evidences have shown that obesity, type 2 diabetes, and NASH increase the risk of developing progressive neurodegenerative disease such as Parkinson’s disease (PD) and Alzheimer’s disease (AD). In addition to peripheral contributions, each of incretins consisting HM15211 have neuroprotective effects in several brain diseases like AD, PD, and ischemia. Previously, we demonstrated that HM15211 exerted neuroprotective effects in MPTP induced subacute PD mice model. Here, we evaluated 1) the neuroprotective effects of HM15211 in chronic MPTP/probenecid PD model, and 2) the protection of AD progression in db/db mice. Chronic PD mice model was induced by 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) in combination with probenecid injection, twice a week for 5 weeks and HM15211 was administered once a week for 6 weeks. Dopaminergic neuronal death by MPTP/probenecid was protected by HM15211, which was derived from anti-inflammatory and anti-oxidative stress effect by HM15211. Also HM15211 decreased alpha synuclein in striatum of chronic mice PD model. Together with these efficacies, HM15211 significantly improved the MPTP/probenecid induced motor impairments in behavior. A db/db mice are well-established diabetic model and reported that db/db mice develop hyperphosphorylation of tau as they grew older. Thus we chose db/db mice to elucidate the prophylactic effect of HM15211 on AD. After once every 2 days subcutaneous administration for 12 weeks, HM15211 reversed inflammatory cytokines and oxidative stress marker, which were increased in db/db mice. Also, increased phosphorylated tau in db/db mice was decreased by HM15211. Based on these observations, HM15211 might be a potential therapeutic option for the neurodegenerative disease.

Disclosure
J.A. Kim: Employee; Self; Hanmi Pharmaceutical. S. Lee: Employee; Self; Hanmi Pharmaceutical. S. Lee: Employee; Self; Hanmi Pharmaceutical. S. Jung: None. Y. Kim: Employee; Self; Hanmi Pharmaceutical. I. Choi: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. S. Kim: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical.
LIK066, a Dual SGLT1/2 Inhibitor, Reduces Weight and Improves Multiple Incretin Hormones in Clinical Proof-of-Concept Studies in Obese Patients With or Without Diabetes
Authors: HE YANLING , HAYNES WILLIAM G. , MEYERS CHARLES D. , AMER AHMED , ZHANG YIMING , MAHLING PING C. , MENDONZA ANISHA E. , MA SHENGLIN , CHUTKOW WILLIAM , BACHMAN ERIC S. 
Published: June 2018

Background: LIK066 is a potent dual inhibitor of SGLT1/2 (IC50: 20.6 and 0.58 nM for SGLT1 and SGLT2). We studied mechanistic effects of dual SGLT1/2 inhibition of SGLT1 in the gut and SGLT1/2 in the kidneys.
Methods: Effects of LIK066 on weight, glucose and a variety of incretin hormones (GLP-1, PYY, GIP, glucagon, insulin) were investigated in: 1) a single dose cross-over study in T2DM, 2) a 14 day randomized, double-masked study in T2DM, 3) a 12-week randomized, double-masked, placebo-controlled study in obese subjects with normoglycemia (NG) or dysglycemia (DG; HbA1c: ≥5.7% and &lt;10%).
Results: LIK066 (2.5, 30, 300 mg single dose) significantly reduced glucose excursion and insulin secretion (p&lt;0.01 at 30 and 300 mg) following oral glucose tolerance test (OGTT) in patients with T2DM (n=12), with the 300 mg dose completely suppressing glucose and insulin excursions. In patients with T2DM (n=30), LIK066 15 mg qd for 14 days reduced blood glucose (41 mg/dL by continuous glucose monitoring) and increased 24-hour urinary glucose excretion (100 g/d on day 14). Furthermore total GLP-1 and PYY increased (AUC0-3hrs &gt;1.5-fold; p&lt;0.05) post-OGTT, while GIP levels were reduced (&gt;50%; p&lt;0.05). In obese subjects (n=88), LIK066 150 mg qd for 12 weeks reduced weight by 5.70% (p&lt;0.001) compared to placebo, with higher effects in DG (6.85%) vs. NG (4.55%). Additionally multiple metabolic parameters improved (reduced waist circumference, postprandial glucose and insulin, and increased postprandial glucagon). LIK066 was generally safe and well tolerated. The most common AEs were headache, flatulence and diarrhea.
Conclusions: LIK066 treatment leads to favorable changes in a variety of metabolic hormones (increased GLP-1, PYY and glucagon, reduced GIP, glucose and insulin), all contributing to WL effects of LIK066. The dual inhibition of SGLT1/2 in both the gut and kidneys is an attractive strategy for obesity or diabetes treatment.

Disclosure
Y. He: None. W.G. Haynes: Employee; Self; AstraZeneca. C.D. Meyers: Employee; Self; Janssen Research & Development. A. Amer: Employee; Self; Novartis Pharmaceuticals Corporation. Stock/Shareholder; Self; Novartis AG. Y. Zhang: Employee; Self; Novartis Pharmaceuticals Corporation. P.C. Mahling: None. A.E. Mendonza: None. S. Ma: None. W. Chutkow: Employee; Self; Novartis Pharmaceuticals Corporation. E.S. Bachman: None.
Triple vs. Dual Therapy with Low-Dose Dapagliflozin plus Saxagliptin vs. Each Monocomponent Added to Metformin in Uncontrolled Type 2 Diabetes
Authors: ROSENSTOCK JULIO , PERL SHIRA , JOHNSSON EVA K. , JACOB STEPHAN 
Published: June 2018

Triple therapy with dapagliflozin (DAPA) 10 mg/d + saxagliptin (SAXA) 5 mg/d added to metformin (MET) has greater efficacy than dual therapy in type 2 diabetes (T2D) inadequately controlled by MET alone. We tested triple therapy with the lower starting dose of DAPA in a randomized, parallel-group, double-blind, 24-week trial (NCT02681094) to evaluate the efficacy and safety of DAPA 5 mg/d + SAXA 5 mg/d add-on therapy vs. add-on of either agent in patients with T2D (A1C 7.5-10%) uncontrolled with stable MET ≥1500 mg/d monotherapy. The primary end point was change in A1C from baseline to week 24; secondary end points were the proportion of participants achieving A1C &lt;7% at week 24 and changes in FPG and body weight from baseline to week 24. At baseline, mean±SD patient characteristics were similar in all arms: age, 56.7±10.5 years; A1C, 8.2±0.9%; BMI, 31.9±5.4 kg/m2; T2D duration, 7.6±6.1 years. Triple therapy resulted in significant decreases in A1C and FPG vs. both dual therapies, and reduced body weight vs. SAXA + MET (Table). Incidences of genital infections were 3.4%, 1.7% and 0%; urinary tract infections 3.1%, 2.0% and 2.4%; hypoglycemia 5.8%, 2.7% and 3.4% for DAPA + SAXA + MET, DAPA + MET and SAXA + MET, respectively.
In conclusion, DAPA 5 mg/d + SAXA 5 mg/d added to MET led to greater improvement in glycemic control vs. either agent added to MET in T2D uncontrolled with MET monotherapy.

Disclosure
J. Rosenstock: Advisory Panel; Self; Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Consultant; Self; Sanofi. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Merck & Co., Inc., Pfizer Inc., Sanofi, Novo Nordisk Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, Intarcia Therapeutics, Inc., Genentech, Inc. S. Perl: Employee; Self; AstraZeneca. E.K. Johnsson: Employee; Self; AstraZeneca. S. Jacob: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH, AstraZeneca, Eli Lilly and Company. Board Member; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk Foundation. Advisory Panel; Self; MSD K.K.. Speaker's Bureau; Self; MSD K.K., Menarini Group, Roche Diabetes Care Health and Digital Solutions.
Disparity of the Efficacy of DPP-4 Inhibitors in Combination with Metformin vs. High Dose Metformin as Initial Treatment between Asian and Caucasian T2DM Patients
Authors: HUANG XIUTING , GAO XUEYING , CAI XIAOLING , JI LINONG 
Published: June 2018

Background: To evaluate the efficacy and safety of DPP-4 inhibitors (DPP-4i) in combination with metformin as initial treatment vs. high or low dose of metformin in type 2 diabetes patients.
Methods: Studies were identified by search of MEDLINE and EMBASE until Nov. 2017. Inclusion criteria were: T2DM; initial treatment; comparing metformin monotherapy vs.s DPP-4i in combination with metformin therapy; the primary endpoint was the change in HbA1c.
Results: A total of 9 studies were included. In Asian drug-naïve T2DM patients, compared with high dose metformin monotherapy(2g/day), high dose metformin initial combine with DPP-4i therapy led to significant decrease in HbA1c (WMD -0.22%), while in Caucasian, combination therapy resulted in -0.53% change. The difference in the reduction of HbA1c between Asian and Caucasian of combination therapy vs. monotherapy was 0.31% with significance in favor of Caucasian population. In terms of fasting plasma glucose (FPG), in Asian patients, combination therapy vs. monotherapy led to -0.40mmol/L change, while in Caucasian, combination therapy vs. monotherapy led to -0.95mmol/L change. The difference in FPG reduction between Asian and Caucasian was 0.55mmol/L with significance in favor of Caucasian patients. The difference in postprandial glucose (PPG) reduction between Asian and Caucasian was 0.94mmol/L in favor of Caucasian. The difference in body weight changes between Asian and Caucasian was 0.50kg with significance body weight gain of Asian patients. Adverse effects were not increased when compared with combination therapy vs. monotherapy.
Conclusion: DPP-4i with metformin as initial treatment was superior to metformin given alone in glycemic control of drug-naïve T2DM. The glucose-lowering efficacy of DPP-4i combination therapy was greater in Caucasian patients than in Asian.

Disclosure
X. Huang: None. X. Gao: None. X. Cai: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Eli Lilly and Company, Bristol-Myers Squibb Company, Novartis AG, Novo Nordisk A/S, Merck & Co., Inc., Bayer AG, Merck Sharp & Dohme Corp., Takeda Development Center Asia, Pte. Ltd., Sanofi, Roche Pharma, Boehringer Ingelheim GmbH. Research Support; Self; AstraZeneca, Roche Pharma, Sanofi, Merck Sharp & Dohme Corp., Novartis AG, Eli Lilly and Company, Bristol-Myers Squibb Company.
Effects of SGLT2 Inhibitors on Renin-Aldosterone System for One Month and Six Months in Type 2 Diabetes
Authors: MORI ICHIRO , ISHIZUKA TATSUO 
Published: June 2018

Previous study has shown SGLT2 inhibitors affect tubule-glomerular feedback in macula densa associated with decreased glomerular filtration rate. Thereby, plasma renin activity(PRA) may acutely increase after treatment with SGLT2 inhibitors. However chronic activation of PRA-aldosterone system may introduce deterioration of atherosclerosis and fibrosis of heart muscle. The purpose of this study is to examine alterations of PRA and aldosterone concentration (PAC) after treatment with SGLT2 inhibitor in type 2 diabetic patients (T2D). We measured PRA and PAC in T2D (age 68±18 years old, men: female = 12:6) after treatment with SGLT2 inhibitors (tofogliflozin: 7 cases, empagliflozin: 6cases, canagliflozin: 3 cases) for 1 months and 6months (8 cases, age 63±16 years old, men: female = 7:1) from 2014 to 2017. Moreover, we could measured each metabolic parameters such as blood glucose, HbA1c, urinary Na/creatinine and blood pressure before and after treatment with SGLT2 inhibitors (SGLT2i) for 1month and 6months in T2D. We analyzed these results with paired t test using JMP12.2.0. SGLT2i significantly increased PRA for only 1month, but not PAC for 1 month and 6 months as follows; before PRA 1.9±2.4 ng/ml/h, 5.8±9.2 ng/ml/h for 1month (p&lt;0.05) and 2.5±3.1 ng/ml/h for 6months, before PAC 104±65 pg/ml, 105±55 pg/ml for 1 month and 123±85 pg/ml for 6 months, respectively. Moreover, when we examined each metabolic parameter before and after treatment for 1 month, each body weight, BS, and HbA1c was significantly decreased (p&lt;0.05). SGLT2i increases urinary sodium excretion, which affects macula densa in juxta-glomerular apparatus, and finally stimulates secretion of renin for 1month, but not for 6 months. The alteration of aldosterone were not observed after treatment with SGLT2 inhibitors for 1 and 6 months. These results suggest that SGLT2 inhibitors acutely affects PRA but not PAC, and chronic activation of PRA and PAC, which might cause cardiovascular events are not found.

Disclosure
I. Mori: None. T. Ishizuka: None.
The Safety of Continuing Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor during Ramadan Fasting in Muslim Patients with Type 2 Diabetes
Authors: YANLI YANLI SHAO , LIM GWYNETH J. , CHUA CHIN LIAN , WONG YIP FONG , YEOH ESTER , SERENA LOW KIAT MUN , SUM CHEE FANG 
Published: June 2018

Methods: This is a single-centre, prospective observational controlled cohort study. Muslim patients aged 18 to 75 years with type 2 diabetes and estimated glomerular rate (eGFR) ≥ 45 ml/min/1.73 m2 were eligible if they had no contraindication to observe Ramadan fasting. Patients in study group received stable dose of SGLT2 Inhibitor for ≥ 3 months prior to enrolment and during study period, while patients in control group were not on SGLT2 inhibitor before and during study period. All participants were to attend baseline visit within 2 months before Ramadan and follow-up visit during Ramadan.
Results: A total of 68 patients of similar baseline characteristics were included in the study: 35 in study group and 33 in control group. During Ramadan fasting, patients from study and control group had similar change in weight (LS mean change of -1.8 vs. -1.1kg, p=0.205), eGFR (LS mean change of -6.0 vs. -4.2ml/min/1.73m2; p= 0.399), sitting systolic BP (LS mean change of - 8.0 vs. -10.4mmHg, p=0.569), sitting diastolic BP (LS mean change of -3.7 vs. - 3.5mmHg, p=0.934) and plasma β-hydroxybutyrate level (LS mean change of -0.01 vs. -0.02mmol/L, p=0.649).
Conclusions: Continued use of SGLT2 Inhibitors during Ramadan in the study had no increased risk in eGFR deterioration, ketonemia, hypoglycaemia and postural hypotension.

Disclosure
Y. Shao Yanli: None. G.J. Lim: None. C. Chua: None. Y. Wong: None. E. Yeoh: None. K. Low: None. C. Sum: None.