bluuebunny/crossref_metadata_2025_split huggingface dataset:
1188-P: Glycemic Efficacy of Sitagliptin in East Asian Populations: A Pooled Analysis
Authors: CONCEICAO JOAO M. , GONZALEZ CLAUDIO D. , ENGEL SAMUEL S. , AHN JONGHO , TOKITA SHIGERU , ZHANG YE , ZHANG RUYA , LAM RAYMOND L. , PONG ANNPEY 
Published: June 2019

The efficacy/safety of sitagliptin (SITA) has been studied in global populations. This post hoc pooled analysis of 20 placebo (PBO)-controlled studies reports data collected specifically in East Asian populations (EAP). Results were summarized for overall EAP and subgroups defined by geography. Change from baseline in A1C was analyzed at week 12 using ANCOVA model with treatment, study, and baseline A1C terms. A1C values following initiation of rescue medication were excluded. Missing A1C values were imputed using LOCF method. Baseline characteristics were generally balanced across treatments (mean A1C 8.5%, age 55-56 years, BMI 25 kg/m2, FPG 177-179 mg/dL, duration T2D 7-8 years). After 12 weeks of SITA, all populations showed significant A1C reductions vs. PBO (Table) and the largest PBO-adjusted reduction was seen in the Japan subgroup. PBO treatment was associated with reductions in A1C in China Mainland (CM), but with increases in Japan. The percentages of SITA-treated pts with A1C &lt;7% were 18.9%, 14.2%, 37.4% and 30.4% for overall EAP, CM, Japan and Other East Asian subgroups, respectively (all p&lt;0.001 vs. PBO). The incidences of hypoglycemia (i.e., symptomatic/asymptomatic) were 13/981 [1.3%] and 5/816 [0.6%] for SITA and PBO, respectively. These results are consistent with previous findings in global populations.

Disclosure
J.M. Conceicao: Employee; Self; Merck Sharp & Dohme Corp. Stock/Shareholder; Self; Merck Sharp & Dohme Corp. C.D. Gonzalez: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. S.S. Engel: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. J. Ahn: Employee; Self; Merck Sharp & Dohme Corp. Stock/Shareholder; Self; Merck Sharp & Dohme Corp. S. Tokita: Employee; Self; Merck Sharp & Dohme Corp. Stock/Shareholder; Self; Merck Sharp & Dohme Corp. Y. Zhang: Employee; Self; Merck Sharp & Dohme Corp. R. Zhang: Employee; Self; Merck Sharp & Dohme Corp. R.L. Lam: Employee; Self; Merck & Co., Inc. A. Pong: None.

Funding
Merck & Co., Inc.
119-OR: Amplified Glucagon Response to Hypoglycemia following AMP-Activated Protein Kinase (AMPK) Activator R481 Treatment in Healthy Rats
Authors: CRUZ ANA M.L. , MALEKIZADEH YASAMAN , VLACHAKI WALKER JULIA M. , SHAW SIMON J. , ELLACOTT KATE L. , BEALL CRAIG 
Published: June 2019

Episodes of insulin-induced hypoglycemia are frequent in type 1 and advanced type 2 diabetes, but pharmaceutical approaches to prevent these are lacking. Cellular stresses such as low blood sugar activate AMPK, which has emerged as a whole body and cellular energy sensor. Direct delivery of AMPK activator to the ventromedial hypothalamus of rodents leads to increased hepatic glucose-production, observed during hyperinsulinemic-hypoglycemic clamp studies, and genetic activation of AMPK in the pancreatic alpha cell increases glucagon release. It may therefore be suitable to target AMPK for hypoglycemia prevention. Here, R481, a novel metformin-like brain permeable AMPK activator, was used to assess the impact of AMPK pathway activation on the counterregulatory response to hypoglycemia.
Hypothalamic glucose sensing GT1-7 cells were treated with R481 and activation of AMPK pathway by phosphorylation assessed using Western Blotting. R481 was administered orally to male Sprague Dawley rats prior to insulin-induced hypoglycemia, following which blood glucose and feeding were measured. A separate cohort of rats underwent a hyperinsulinemic-hypoglycemic clamp study where glucose infusion rates and counterregulatory hormones levels were determined.
Nanomolar concentrations of R481 increased AMPK pathway phosphorylation in GT1-7 neurons. Administration of R481 (5-20 mg/kg) to rats attenuated insulin-mediated drop in blood glucose during acute insulin-induced hypoglycemia, without altering fast-induced refeeding. R481 decreased the glucose infusion rate during hyperinsulinemic-hypoglycemic clamps, by amplifying plasma glucagon secretion, without altering epinephrine.
Peripheral administration of AMPK activator R481 amplified glucagon release to improve counterregulatory response to hypoglycemia in healthy rats.

Disclosure
A.M.L. Cruz: None. Y. Malekizadeh: None. J.M. Vlachaki Walker: None. S.J. Shaw: Employee; Self; Rigel Pharmaceuticals. K.L. Ellacott: None. C. Beall: None.

Funding
JDRF; Diabetes UK
12-LB: Beta Blocker Type and Hypoglycemia in Hospitalized Patients
Authors: LONG CLARINE , BINKLEY PHILIP F. , DUNGAN KATHLEEN M. 
Published: June 2019

Background: Although β-blockers (BB) could increase the risk of hypoglycemia, the difference between subtypes on hypoglycemia and mortality have not been studied.
Aim: To determine the relationship between type of BB and incidence of hypoglycemia and mortality in hospitalized patients.
Methods: We retrospectively identified non-critically ill hospitalized patients who were undergoing bedside glucose monitoring over a 2 year period. Admission BB was categorized as carvedilol (C) or selective BB (SBB). Other nonselective BB were excluded. Hypoglycemia was defined as any glucose &lt; 70 mg/dl within 24 hours of admission (Hypo24) or throughout hospitalization (HypoT) and any glucose &lt;40 mg/dl throughout hospitalization (Hypo40).
Results: There were 1022 patients on C, 886 on SBB, and 10,217 on no BB. After controlling for other variables, the odds of Hypo24 HypoT and Hypo40 were higher for BB recipients, and the odds were greater for SBB vs. carvedilol for HypoT (Table). Findings were not observed in heart failure patients. Hypo24, HypoT, and Hypo40 were all associated with increased mortality in adjusted models among non-BB and C recipients, but not among SBB recipients.
Conclusions: BB use is associated with hypoglycemia, except in heart failure. C is associated with lower odds of hypoglycemia compared to SSB. Moreover, hypoglycemia associated mortality was attenuated with C. The findings warrant further study among patients with diabetes.

Disclosure
C. Long: None. P.F. Binkley: None. K.M. Dungan: Advisory Panel; Self; Eli Lilly and Company, Elsevier, Sanofi-Aventis. Research Support; Self; Eli Lilly and Company, GlaxoSmithKline plc., Novo Nordisk Inc., Sanofi-Aventis, Viacyte. Other Relationship; Self; DKBmed, UpToDate.
120-LB: Early Real-World Hypoglycemia Outcomes with Use of the Tandem Basal-IQ Technology System
Authors: PINSKER JORDAN E. , CASTORINO KRISTIN N. , LEAS SCOTT A. ,   STEPHANIE HABIF
Published: June 2019

The Tandem t:slim X2™ insulin pump with Basal-IQ® technology predicts glucose levels 30 minutes ahead based on the last 4 consecutive CGM readings. Insulin delivery is suspended if the predicted sensor glucose (SG) is &lt;80 mg/dL or if the observed SG is &lt;70 mg/dL. Insulin delivery resumes as soon as SG begins to rise. The pivotal trial (PROLOG) showed 3 weeks of Basal-IQ® use reduced SG time &lt;70 mg/dL by 31% compared to sensor-augmented pump.
De-identified data voluntarily uploaded to the t:connect® diabetes management application between August 30, 2018, and February 7, 2019, from individuals with diabetes who have used Basal-IQ® technology for 3, 6, and 9 weeks (N=4082, 2370, and 1307 respectively) were retrospectively analyzed. Real-world Basal-IQ® hypoglycemia outcomes were compared to the PROLOG results.
After 3 weeks of real-world use, median time SG &lt;70 mg/dL was 1.0% overall (1.0% daytime and 0.9% nighttime) vs. 2.6% (2.4% daytime and 2.7% nighttime) in PROLOG. Median time with SG &lt;60 was 0.3% and time &lt;50 mg/dL was 0.1%, vs. 0.9% and 0.2% in PROLOG. After 6 and 9 weeks, median time SG &lt;70 mg/dL was 1.1%. Number of insulin suspensions and suspension duration were similar to PROLOG (Table 1).
Basal-IQ® technology was found to be safe and effective in a real-world setting, with similar PLGS activation metrics as observed in PROLOG. Results showed the Basal-IQ® algorithm performs successfully at preventing hypoglycemia.

Disclosure
J.E. Pinsker: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Insulet Corporation, LifeScan, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker’s Bureau; Self; Tandem Diabetes Care. K.N. Castorino: Consultant; Self; Abbott. Research Support; Self; Abbott, Dexcom, Inc., Drawbridge, Novo Nordisk Inc., Sanofi US. S.A. Leas: Employee; Self; Tandem Diabetes Care. S. Habif: Employee; Self; Tandem Diabetes Care.

Funding
Tandem Diabetes Care, Inc.
120-OR: MicroRNA-7a-5p Overexpression in the VMH Restores the Sympathoadrenal Response to Hypoglycemia in Recurrently Hypoglycemic Rats
Authors: AGRAWAL RAHUL , MONTGOMERY MICHAEL G. , VERMA DINESH , DURUPT GRIFFIN T. , DE ABREU ADRIANA VIEIRA , SWAMINATHAN SANKAR , FISHER SIMON 
Published: June 2019

We tested the hypothesis that the impaired sympathoadrenal response induced by recurrent hypoglycemia (RH) is mediated by changes in key microRNA expression in the ventromedial hypothalamus (VMH). MicroRNA-sequencing data from the VMH of RH rats indicated a 67% downregulation of microRNA-7a-5p and a 2.3-fold upregulation of microRNA-665. Rescue experiments were conducted consisting of lentiviral-mediated overexpression of microRNA-7a-5p or downregulation of microRNA-665 targeted to the VMH. Rats were randomized to, 1) recurrent saline (RS), 2) RH (25-50 mg/dl x 3 days), 3) RH + Lenti-scrambled microRNA, or 4) RH + Lenti-targeted microRNA. All rats were subsequently subjected to hyperinsulinemic-hypoglycemic (40-50 mg/dl) clamps. As expected, RH induced a blunted sympathoadrenal hormone response to hypoglycemia. Targeted VMH overexpression (∼3.5 fold) of microRNA-7a-5p in RH rats normalized the epinephrine response to hypoglycemia coinciding with a 30% decreased glucose infusion rate. Targeted VMH downregulation of microRNA-665, however, did not improve counterreguatory responses. These findings indicate that microRNA-7a-5p is a potential mediator of impaired VMH glucose sensing/counterregulation and may be an effective therapeutic target to restore impaired sympathoadrenal responses to hypoglycemia.

Disclosure
R. Agrawal: None. M.G. Montgomery: None. D. Verma: None. G.T. Durupt: None. A. Vieira de Abreu: None. S. Swaminathan: None. S. Fisher: None.
1210-P: Pooled Analysis of the Safety and Efficacy of Ertugliflozin in the Elderly
Authors: PRATLEY RICHARD E. , DAGOGO-JACK SAMUEL , CHARBONNEL BERNARD , PATEL SHRITA M. , HICKMAN MARY A. , LIU JIE , TARASENKO LISA , ELLISON MISOO C. , GANTZ IRA , TERRA STEVEN G. 
Published: June 2019

Ertugliflozin (ERTU), an SGLT2 inhibitor, improves glycemic control in adult patients (pts) with T2DM. Elderly pts with T2DM are underrepresented in clinical studies, often present with multiple co-morbidities and are more susceptible to adverse events (AEs). Pooled analyses based on 7 phase 3 studies from the VERTIS program evaluated the safety and efficacy of ERTU in subgroups of pts aged &lt;65 and ≥65 years. Pts with T2DM received ERTU (5 or 15 mg ± sitagliptin [SITA] 100 mg) or control (placebo [PBO], glimepiride or SITA). Safety data were evaluated up to 104 weeks. Efficacy was assessed in a subset of 3 PBO-controlled studies at 26 weeks. Baseline (BL) characteristics were similar between pts aged &lt;65 (n=3605) and ≥65 years (n=1254), with the exception of mean BL estimated glomerular filtration rates (90.2 mL/min/1.73 m2 in pts &lt;65 and 71.4 mL/min/1.73 m2 in pts ≥65). The safety profile of ERTU was similar in both age groups, except for a higher incidence of volume depletion AEs with ERTU relative to control (2.4% vs. 1.1%) in pts ≥65. Excluding pts with BL moderate renal impairment, incidence of renal-related AEs was similar across groups in pts ≥65 (ERTU [0.6%] vs. control [0.8%]), suggesting age alone does not increase risk of renal-related AEs. In the 3 PBO-controlled studies, documented hypoglycemia (4.4% vs.6.0%) and severe hypoglycemia rates (0.4% vs. 0.4%) with ERTU were comparable in pts &lt;65 and ≥65. Efficacy of ERTU by age group is shown in the Figure.

Disclosure
R.E. Pratley: Consultant; Self; Sanofi US. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Janssen Global Services, LLC., Janssen Research & Development, Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk Inc., Pfizer Inc., Sanofi, Takeda Development Center Americas, Inc. S. Dagogo-Jack: Board Member; Self; Jana Care Inc. Consultant; Self; Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi-Aventis. Research Support; Self; AstraZeneca, Novo Nordisk Inc. Stock/Shareholder; Self; Dance Biopharm Holdings Inc. B. Charbonnel: Consultant; Self; AstraZeneca, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Servier. Speaker's Bureau; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Takeda Pharmaceutical Company Limited. S.M. Patel: Stock/Shareholder; Spouse/Partner; Janssen Pharmaceuticals, Inc. Stock/Shareholder; Self; Merck & Co., Inc. M.A. Hickman: Employee; Self; Pfizer Inc. J. Liu: Employee; Self; Merck & Co., Inc. L. Tarasenko: Employee; Self; Pfizer Inc. M.C. Ellison: Employee; Self; Merck & Co., Inc. I. Gantz: Employee; Self; Merck & Co., Inc. S.G. Terra: Employee; Self; Pfizer Inc.

Funding
Merck Sharp & Dohme Corp; Pfizer Inc.
122-OR: Impact of Withdrawal of Interventions in the Restoring Insulin Secretion (RISE) Pediatric Medication Study
Authors: HANNON TAMARA S. , EDELSTEIN SHARON , ARSLANIAN SILVA A. , CAPRIO SONIA , ZEITLER PHILIP , BUCHANAN THOMAS A. , EHRMANN DAVID A. , MATHER KIEREN J. , LESCHEK ELLEN , TRIPPUTI MARK , KAHN STEVEN E. , NADEAU KRISTEN J. , CONSORTIUM RISE 
Published: June 2019

The RISE Pediatric Medication Study showed, in 91 obese 10-19 yo youth with impaired glucose tolerance (IGT, 60%) or recent-onset type 2 diabetes (T2D, 40%), that 12 mo of intervention with metformin alone (M) or glargine for 3 mo followed by metformin for 9 mo (G+M) resulted in no change in BMI or HbA1c and a decline in β-cell function measured by hyperglycemic clamp. These outcomes worsened 3 mo after withdrawal of the interventions. We expand our findings to mo 21 (M21) post randomization (9 mo after withdrawal of M or G+M) using oral glucose tolerance test (OGTT) measures of β-cell responsiveness (C-peptide index, CPI; insulinogenic index, IGI; incremental C-peptide/glucose area under the curve), BMI and HbA1c. Paired t-tests were used to compare treatment groups on changes from baseline (BL, n=91) to mo 12 (M12, n=86) and M21 (n=82), and from treatment withdrawal at M12 to M21. At M12 vs. BL, no measures differed in either group (Table). At M21 vs. BL, HbA1c increased in both groups, and BMI increased and CPI and IGI declined in the G+M group. At M21 vs. M12, BMI, HbA1c, fasting and 2-h glucose increased in both groups, and CPI declined in the G+M group. Our findings contrast with studies in adults showing durable benefits of metformin and insulin on HbA1c and β-cell responsiveness. Further investigation is needed to find effective treatments that prevent progression of dysglycemia in youth with IGT or recent-onset T2D.

Disclosure
T.S. Hannon: Advisory Panel; Self; Eli Lilly and Company. S. Edelstein: None. S.A. Arslanian: None. S. Caprio: None. P. Zeitler: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Research & Development, Merck & Co., Inc., Novo Nordisk Inc. T.A. Buchanan: Research Support; Self; Allergan, Apollo EndoSurgery. D.A. Ehrmann: None. K.J. Mather: Advisory Panel; Self; Roche Diabetes Care. Research Support; Self; Abbott, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. E. Leschek: None. M. Tripputi: None. S.E. Kahn: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S. Consultant; Self; Neurimmune. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S. K.J. Nadeau: None. R. Consortium: None.

Funding
American Diabetes Association (1-14-RISE-01 to S.E.K.); National Institute of Diabetes and Digestive and Kidney Diseases
1222-P: Comparative Efficacy of Ertugliflozin (ERTU) vs. Other Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i): Model-Based Meta-analysis (MBMA) of HbA1c Lowering
Authors: FEDIUK DARYL , MANDEMA JAAP , SWEENEY KEVIN , TERRA STEVEN G. , SAHASRABUDHE VAISHALI 
Published: June 2019

Background: ERTU is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor approved for the treatment of adults with type 2 diabetes mellitus (T2DM). As several SGLT2i are commercially available, MBMA of the HbA1c-lowering effect of these drugs was undertaken to assess their comparative effectiveness.
Methods: MBMA quantified the time course of dose vs. HbA1c response of SGLT2i and evaluated the impact of covariates including baseline HbA1c, estimated glomerular filtration rate (eGFR) and background diabetes treatment on HbA1c efficacy. Of the 496 randomized controlled trials (RCTs) in the database, 94 RCTs representing &gt;31,000 T2DM patients were with SGLT2i, including 5 RCTs for ERTU.
Results: For SGLT2i, there was a 28.7% (95% CI, 24.5 to 33.1%) greater relative HbA1c efficacy for a 1% absolute increase in baseline HbA1c. Additionally, the HbA1c efficacy was 25.0% (17.0 to 34.0%) greater on a diet background alone relative to a background of metformin (or other oral antidiabetic treatment). For every 10 mL/min/1.73m2 decrease in eGFR, there was a 8.80% (5.90 to 11.6%) decrease in HbA1c efficacy.
Conclusion: This MBMA allowed an indirect comparison of SGLT2 inhibitor efficacy across trials (Table). Overall, ERTU doses of 5 and 15 mg were of comparable or numerically greater efficacy to other SGLT2i.

Disclosure
D. Fediuk: Employee; Self; Pfizer Inc. J. Mandema: Consultant; Self; Merck & Co., Inc., Pfizer Inc., Sanofi. K. Sweeney: Employee; Self; Pfizer Inc. S.G. Terra: Employee; Self; Pfizer Inc. V. Sahasrabudhe: Employee; Self; Pfizer Inc.

Funding
Pfizer Inc.; Merck Sharp & Dohme Corp.
1223-P: Empagliflozin vs. Dapagliflozin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin, Glimepiride, and Dipeptidyl Peptide-4 Inhibitors: A 52-Week Prospective Observational Study
Authors: KU EU JEONG , LEE DONG HWA , JEON HYUN JEONG , OH TAEKEUN 
Published: June 2019

Objectives: To directly compare the effectiveness of HbA1c reduction between two distinct SGLT2 inhibitors, Empagliflozin (EMPA, 25 mg/day) and Dapagliflozin (DAPA, 10 mg/day), as part of a quadruple OAD drug regimen.
Research Design and Methods: This study was an open-labeled, prospective, observational, 52-week study conducted in a clinical practice. T2D patients (HbA1c, 7.5-12.0%) with three different OADs (metformin, glimepiride, and dipeptidyl peptidase-4 inhibitors) were enrolled to either EMPA or DAPA. The outcome measures included changes in HbA1c, fasting plasma glucose (FPG), and cardiometabolic variables at week 52 and the safety outcomes of treatment-emergent adverse events.
Results: In total, 350 patients were enrolled with EMPA (N=176) and DAPA (N=174), respectively. After 52 weeks, both groups showed significant reductions (P &lt;0.001) in HbA1c and FPG, but the reduction was greater in the EMPA group. In addition, both groups showed decreased blood pressure and body weight with improved liver function, and high-density lipoprotein cholesterol levels were significantly increased in the EMPA (1.9 ± 5.7 mg/dl, P &lt;0.001 and 0.6 ± 4.5 mg/dl, P = 0.157, respectively) (between groups, P = 0.035). Both groups were well tolerated with overall similar safety profiles.
Conclusions: Our present study demonstrated that SGLT2 inhibitors can be safely and effectively used as a fourth OAD in T2D patients who are already being treated with three other OADs to control their hyperglycemia. More specifically, Empagliflozin was more effective in reducing HbA1c and improving other cardiometabolic parameters affecting patient health in T2D. Our findings show that 4 different OADs can be used as a viable therapeutic regimen to treat T2D, especially in patients who are unwilling to use injectable therapies as their alternate method to control blood glucose.

Disclosure
E. Ku: None. D. Lee: None. H. Jeon: None. T. Oh: None.
1226-P: Antifibrotic Effect of Combination Dapagliflozin and Metformin Therapy in Patients with Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease
Authors: LAVRYNENKO OLGA , KRAVCHUN NONNA , ZEMLIANITSYNA OLHA , DUNAEVA INNA , DEFRONZO RALPH A. , CERSOSIMO EUGENIO , KARACHENTSEV IURIY 
Published: June 2019

Objective: Evaluation of long-term results of combination therapy with dapagliflozin and metformin on fibrotic changes in the liver of patients with type 2 diabetes (DM) and nonalcoholic fatty liver disease (NAFLD).
Materials and Methods: We recruited 45 DM patients with clinical NAFLD (27M, 18F) and in addition to dietary recommendations all received dapagliflozin 10 mg/daily plus metformin (max 2000 mg/daily); 7 patients required additional therapy with insulin.
Results: As well documented in the literature, the efficacy of the dapagliflozin/metformin combination in the treatment of DM patients with NAFLD was shown in our series. Improvements in glycemic indices (HbA1c- 7.17 ± 0.16vs. 7.05 ± 0.18; FPG - 10.85 ± 0.48vs. 9.39 ± 0.46,р &lt; 0.05), a reduction of BMI (31.04 ± 0.63kg/m2vs. 29.55 ± 0.50kg/m2, р &lt; 0.05) and in liver function (AST/ALT 0.83 ± 0.05vs. 0.74 ± 0.05) observed during the long-term (16 months) administration of these drugs. The NAFLD, FIB-4 and APRI scales were used to determine the risk of liver fibrosis in this group of DM patients. After the start of the combination therapy, all scales showed decreases in the level of non-invasive liver fibrosis indices of these patients. The most sensitive method for the early diagnosis of liver fibrosis was the NAFLD scale, which decreased significantly (-0.941 ± 0.11 vs. -1.61 ± 0.12 points, р &lt; 0,001). Following treatment, the number of patients with mild liver fibrosis increased from 8 (27.6%) to 21 (64.9%) and those in the "gray zone" also decreased from 29 (72.6%) to 13 (35.1%).
Conclusion: In this non-randomized, single treatment arm group of DM patients study, we demonstrated that following combination therapy of dapagliflozin plus metformin for 16 months, better glycemic control is accompanied by simultaneous improvements in liver function tests and superior NAFLD scale values of liver fibrosis.

Disclosure
O. Lavrynenko: None. N. Kravchun: None. O. Zemlianitsyna: None. I. Dunaeva: None. R.A. DeFronzo: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Elcelyx Therapeutics, Inc., Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk Inc. E. Cersosimo: None. I. Karachentsev: None.