bluuebunny/crossref_metadata_2025_split huggingface dataset:
COMPARATIVE BIOEQUIVALENCE STUDIES OF CINNARIZINE AND ITS DIFFERENT AVAILABLE MARKETED FORMULATION DRUGS
Authors: KUMAR SANJEEV , M AMIN MIR , KUMAR SARVESH , KUMAR ANUJ 
Published: June 2020

Objective: The main focus of the study was to investigate the marketed formulations of cinnarizine and it is marketed analogous.
Methods: The study involved the analysis of basic pre-formulation studies, namely, physical properties, melting point, Fourier-transform infrared, loss on drying, assay of cinnarizine, standard curve, and partition co-efficient of various marketed tablets of cinnarizine.
Results: Cinnarizine is an H1-receptor antagonist drug which is widely used for the treatment of dynamical sickness, vomiting, and vertigo. In this study, five known marketed formulations of cinnarizine were evaluated for weight variation, hardness, drug content, friability, disintegration time, and in vitro dissolution as well as the drug release kinetics of the tablets. As per the study, the drugs show low disintegration time and good hardness, also in vitro dissolution studies have shown near about 90% drug release at the end of the first 10 min and then cumulative drug release of not less than 92% in the nearby 10 min. Hence, these formulations show lower friability, acceptable taste, and shorter disintegration time which make them suitable to be accepted. Thus, the tablets are good for the use, so allow them to be marketed for the wellbeing of humans.
Conclusion: It had been found that all the tablets show acceptable limits for various parameters of analysis, in a sustained manner. Thus, all the tablets are effective for usage under standard conditions.
COMPARATIVE EFFECTIVENESS STUDY OF COMBINED ANTIHYPERTENSIVES FOR NIGERIAN PATIENTS
Authors: UKWE CHINWE VICTORIA , ADIBE MAXWELL OGOCHUKWU , CE OKAFOR , C ANOSIKE , A ISAH , SO IKE , BC ANISIUBA , GC NWURUKU 
Published: June 2020

Objective: The objective of the study was to compare the clinical and economic effectiveness of four combination antihypertensives recommended for Nigerians.
Methods: An open, randomized, controlled, and longitudinal double-blind trial of four groups of antihypertensives combinations: Telmisartan/ chlorthalidone/amlodipine (TCA), TC, CA, and TA was conducted among hypertensive patients. The participants were recruited from three hospitals in Enugu, and randomly assigned to the study groups. The primary outcome for this study was blood pressure (BP) control, based on Joint National Committee-8 and cost per BP control. The secondary outcomes were cost per quality adjusted life years (QALY) and patients’ self-reported health status. Descriptive and inferential statistics were used for statistical analysis.
Results: Of the 110 patients enrolled in the study, more than half were women (55.5%). The mean age of patients was 54.93±12.38. The enrollees had hypertension for over 9 years (9.17±8.40). About 77% of the patients completed the study in all the groups except for TA (66.7%). There was no difference in BP in all the groups at baseline and at end-of-study (p>0.050). However, the probability of BP control was highest in TCA group (0.37±0.01), followed by TC group (0.23±0.02). The TA group showed the most favorable cost per QALY, then CA, TC, and TCA in that order. The group with the most favorable cost per BP control was TCA (70.92±0.04), then TA (94.16±0.05).
Conclusion: The triple combination therapy of TCA had the best cost per BP control in the management of hypertensive patients. It demonstrated the highest probability of BP control.
ANTI-INFLAMMATORY PROFILING OF SEED AND RIND EXTRACTS OF AMOMUM SUBULATUM
Authors: AGNIHOTRI SUPRIYA 
Published: June 2020

Objective: The study aimed to evaluate the anti-inflammatory activity of Amomum subulatum (greater cardamom) seed and rind extracts in Wistar rats.
Methods: The seed and rind of A. subulatum were air-dried in the shade, powdered, and subjected to 80% hydroalcoholic extraction in the Soxhlet apparatus. The anti-inflammatory activity of the seed and rind extracts of A. subulatum was evaluated by in vivo and in vitro methods.
Results and Discussion: In vivo studies, namely, carrageenan-induced rat paw edema, cotton pellet granuloma, and formaldehyde-induced arthritis model confirmed the anti-inflammatory potential of seed and rind extracts of A. subulatum. It was found that rind extract exhibited better inhibition of inflammation as compared to seed extract. A. subulatum rind extract at the dose of 500 μg/ml exhibited best results for in vitro studies, namely, inhibition of albumin denaturation (73% inhibition), antiproteinase action (58% inhibition), membrane stabilization, heat-induced hemolysis, hypotonicity-induced hemolysis (54% inhibition), anti-lipoxygenase activity.
Conclusions: The results of the study showed that the rind extract of A. subulatum (greater cardamom) possesses significant anti-inflammatory potential in various in vivo and in vitro anti-inflammatory models in the experimental animals.
100-LB: Closed-Loop Control Reduces Hypoglycemia without Increased Hyperglycemia in Subjects with Increased Prestudy Hypoglycemia: Results from the iDCL DCLP3 Randomized Trial
Authors: LEVY CAROL J. , O’MALLEY GRENYE , BROWN SUE A. , FORLENZA GREGORY P. , KUDVA YOGISH C. , BECK ROY , KOLLMAN CRAIG , LUM JOHN , RAGHINARU DAN , KOVATCHEV BORIS 
Published: June 2020

Closed Loop Control (CLC) has the ability to reduce both hypoglycemia and hyperglycemia. We conducted a post-hoc analysis of data from the iDCL DCLP3 randomized trial comparing CLC with Control-IQ versus sensor augmented pump therapy (SAP) for 6 months in participants who had baseline CGM below 70mg/dL ≥4.0% of the time (N= 41 CLC, 14 SAP, mean±SD age of 33±16yrs, 49% female). CLC use led to a greater reduction in time below 70mg/dL (least square mean change from baseline of -4.6% in CLC vs. -3.1% in SAP, mean-adjusted treatment difference -1.5% or 22 min/d, 95% CI -2.2% to -0.9%, P&lt;0.0001), increased time in range 70-180 mg/dL (mean-adjusted difference +10.4% or 2.5 hr/d, P&lt;0.0001), decreased time above 180mg/dL (mean-adjusted difference -8.5% or 2.0 hr/d, P=0.0001), decreased mean glucose (mean-adjusted difference -10.4 mg/dL, P=0.005), and lower HbA1C (mean-adjusted difference -0.28%, P=0.06). CLC improves HbA1C and reduces both hypoglycemia and hyperglycemia in people with T1D with elevated levels of hypoglycemia prior to starting CLC.

Disclosure
C.J. Levy: Consultant; Self; Dexcom, Inc. Employee; Spouse/Partner; Allergan plc. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation. G. O’Malley: Research Support; Self; Abbott, Dexcom, Inc. S.A. Brown: Research Support; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Tolerion, Inc. G.P. Forlenza: Advisory Panel; Self; Medtronic. Consultant; Self; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. Y.C. Kudva: Research Support; Self; Dexcom, Inc., Roche Diabetes Care. Other Relationship; Self; Abbott. R. Beck: None. C. Kollman: Other Relationship; Self; Dexcom, Inc., Tandem Diabetes Care. J. Lum: None. D. Raghinaru: None. B. Kovatchev: Advisory Panel; Self; Dexcom, Inc. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc., Sanofi, Tandem Diabetes Care. Other Relationship; Self; Dexcom, Inc., Johnson & Johnson, Sanofi.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (UC4108483); University of Virginia Strategic Investment Fund (Project 88); Tandem Diabetes Care
1000-P: A Feasibility Study Assessing the Accuracy of a Simplified Meal-Time Bolus Calculation Option
Authors: ROY ANIRBAN , GROSMAN BENYAMIN , LINTEREUR LOUIS J. , PARIKH NEHA , WU DI , SHULMAN DOROTHY I. , CHRISTIANSEN MARK P. , SLOVER ROBERT H. , WEYDT PATRICK E. , VIGERSKY ROBERT 
Published: June 2020

Carbohydrate counting is a significant source of burden for individuals using insulin to mitigate postprandial glucose excursion. To address this, a meal simplification (MS) algorithm was developed that allows one to choose a ready and user-specific small, medium, large, extra-large (S/M/L/XL) carb-entry size for meal-time boluses.
Subjects with T1D (N=12, 15-76 yrs) underwent a 4-week learning phase where traditional carb-counting and entry were carried out via the MinMed™ 670G system. At the end of the learning phase, the MS algorithm used machine-learning techniques and insulin pump data to identify clusters of meals (a set of S/M/L/XL meal sizes along with a corresponding centroid carb value) on which a meal bolus would be calculated. Immediately after, there was a 2-week study phase where subjects announced carbs based on their personalized S/M/L/XL meal sizes.
Postprandial SG levels after S/M/L/XL announcements did not differ from those after traditional carb-counting (Table) and suggest that the personalized S/M/L/XL option is a valid alternative for carbohydrate counting. It may alleviate some of the burden associated with meal-time carb-counting, and potentially improve meal-time bolusing compliance.

Disclosure
A. Roy: Employee; Self; Medtronic. B. Grosman: Employee; Self; Medtronic. L.J. Lintereur: Employee; Self; Medtronic. N. Parikh: None. D. Wu: None. D.I. Shulman: Advisory Panel; Self; Medtronic. M.P. Christiansen: Research Support; Self; Abbott, Ascensia Diabetes Care, Biolinq, Dexcom, Inc., Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi-Aventis, Senseonics, ViroMed Laboratories, Xeris Pharmaceuticals, Inc. R.H. Slover: None. P.E. Weydt: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic.
1006-P: Personalized Hybrid Closed-Loop Therapy Using a Digital Twin in Patients with Type 1 Diabetes: At-Home Data
Authors: GROSMAN BENYAMIN , ROY ANIRBAN , WU DI , PARIKH NEHA , LINTEREUR LOUIS J. , SCHNEIDER NICOLE , BRAZG RONALD L. , GARG SATISH K. , VIGERSKY ROBERT 
Published: June 2020

Background: MiniMed™ 670G system user-dependent settings influence glycemic outcomes in persons with type 1 diabetes. The ability of a mathematical model-based digital-twin program to personalize and automate user-dependent MiniMed™ 670G settings was assessed.
Method: A small feasibility study recruited experienced MiniMed™ 670G system users (N=19 users, &gt;14yrs) to complete an at-home 3-weeks run-in phase with Auto Mode enabled followed by a 2-weeks study phase. Run-in data were used to generate a digital twin that personalized system settings during the study phase that comprised a non-randomized Auto Mode and Manual Mode arm. System use and glycemic outcomes were assessed.
Results: Personalized Auto Mode (Auto Mode+) reduced the mean(SD) of sensor glucose (SG) from 151.1(12.3)mg/dL to 149.3(11.6)mg/dL and increased time spent in target SG range from 74.0% to 75.9% (Table). Personalized Manual Mode (Manual Mode+) demonstrated a mean SG and TIR of 150.1mg/dL and 67.4%, respectively.
Conclusions: Improved Auto Mode therapy and acceptable Manual Mode (sensor-augmented pump) therapy were observed utilizing a digital-twin program to personalize MiniMed™ 670G system settings in subjects whose glycemic control was excellent at baseline. This is the first demonstration that a digital-twin can successfully automate and personalize insulin pump therapy.

Disclosure
B. Grosman: Employee; Self; Medtronic. A. Roy: Employee; Self; Medtronic. D. Wu: None. N. Parikh: None. L.J. Lintereur: Employee; Self; Medtronic. N. Schneider: None. R.L. Brazg: None. S.K. Garg: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Diagnostics France. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. R. Vigersky: Employee; Self; Medtronic.
1008-P: 3D Acoustic Radiation Force Impulse Virtual Imaging of Whole Human Abdominal Subcutaneous Tissue Imaging with “Insulin Ball”
Authors: SATO GENKI , UCHINO HIROSHI , SHIMIZU YOSUKE , ISHII KEN , ISHIKO AKIRA , MORITA TOSHISUKE , KUMASHIRO NAOKI , HIROSE TAKAHISA 
Published: June 2020

Introduction: Current evidence suggests that subcutaneous “insulin ball”, a feature of the tissue-dystrophy, provokes hormonal perturbation in insulin absorption. Unforeseen 3-dimension (3D) whole human abdominal subcutaneous tissue within the insulin injecting subjects, we tried to elucidate a novel 3D ultrasound acoustic radiation force impulse (3D-ARFI) to quantitates the entire “tissue-dystrophy” volume in human.
Methods: Seven patients with daily insulin injected diabetes were enrolled and the 3D-ARFI was applied to measure tissue displacement. To generate the elasticity gradients along the depth axis of the whole abdominal subcutaneous tissue, we compared lateral region of the abdomen as internal-control. A subcutaneous insulin tolerance test was conducted to validate the rate of insulin absorption at the site of the tissue-dystrophyand control. We also analyzed the volume of whole insulin induced tissue-dystrophy with entire abdominal wall volume governed by consecutive ARFI slice imaging.
Results: Subcutaneous tissue stiffness measured by ARFI revealed that ARFI enabled the elastic characterization (p&lt;.01). The 3D-ARFI demonstrated the differentiated elastic layers in the 3D model of entire human abdominal wall, and calculatedthe 3D volume of the tissue-dystrophy from entire abdominal subcutaneous volume (2.59±1.20%). The serum concentration area-under the curve (0-240min) after the 0.1U/kg IAsp injection was 33% lower at the tissue-dystrophylesions compared to the control lesion (p&lt;.05).
Conclusion: We present the first example of virtual touch quantification imaging with the 3D-ARFI of human abdominal subcutaneous tissue, focusing on insulin injected diabetes and demonstrate its application for the biomedical 3D structure.

Disclosure
G. Sato: None. H. Uchino: None. Y. Shimizu: None. K. Ishii: None. A. Ishiko: None. T. Morita: None. N. Kumashiro: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Self; Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. T. Hirose: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Mitsubishi Tanabe Pharma Corporation, Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. Speaker’s Bureau; Self; AstraZeneca, Lilly Diabetes, Novo Nordisk Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd.

Funding
Japan Society for the Promotion of Science (17K01425)
102-LB: Cross-Study Comparisons Done Right: An Illustration Using Two Pivotal Trials of Closed-Loop Systems
Authors: BRETON MARC D. , BECK ROY , BERGENSTAL RICHARD M. , KOVATCHEV BORIS 
Published: June 2020

Outcomes are regularly compared across studies frequently leading to inaccurate conclusions due to sampling differences. We introduce distribution-adjusting methods allowing for more adequate cross-study comparisons.
To illustrate these methods, we use time-in-range 70-180mg/dl (TIR) from two closed loop system pivotal clinical trials: CLS1 for MiniMed 670G (Medtronic), and CLS2 for Control-IQ (Tandem). TIR was the key outcome measure for both, but baseline TIRs were different (Table 1).
Furthermore, CLS1 did not have a control group; rendering the otherwise best option, a comparison of the experimental vs. control deltas, inapplicable. A second-best option is to compare the increments from baseline to active-treatment TIRs, which causes two opposing statistical artifacts: (1) with higher baseline, active-treatment TIR would be higher, and (2) with higher baseline, the TIR increment would be lower due to a ceiling effect.
Three methods were used to mitigate these artifacts by matching baseline TIRs distributions: sample truncation, weighted resampling, and baseline cumulative distribution functions mapping. All three resulted in similar Adjusted TIRs (Table 1).
Comparing results across studies is possible, if limited to the relative improvements from baseline to active treatment. However, comparing absolute results will not be accurate without proper baseline adjustments.

Disclosure
M.D. Breton: Research Support; Self; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Tandem Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc., Tandem Diabetes Care. R. Beck: None. R.M. Bergenstal: Consultant; Self; Ascensia Diabetes Care, Johnson & Johnson. Other Relationship; Self; Abbott, Dexcom, Inc., Hygieia, Lilly Diabetes, Medtronic, Novo Nordisk A/S, Onduo, Roche Diabetes Care, Sanofi, UnitedHealth Group. B. Kovatchev: Advisory Panel; Self; Dexcom, Inc. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc., Sanofi, Tandem Diabetes Care. Other Relationship; Self; Dexcom, Inc., Johnson & Johnson, Sanofi.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108483)
1022-P: Efficacy of Sliding Scale Insulin for Inpatient Glycemic Control in a Multinational Propensity-Matched Cohort Study
Authors: MIGDAL ALEXANDRA , FORTIN CHARLIE , GUO YI , HOCHBERG IRIT , MAGEE MICHELLE F. , PASQUEL FRANCISCO J. , UMPIERREZ GUILLERMO E. 
Published: June 2020

Sliding scale insulin (SSI) continues to be widely used for glycemic management of inpatients with T2D despite condemnation in clinical guidelines. To confirm the accuracy of this clinical guideline recommendation, we determined the efficacy and safety of using SSI for the management hyperglycemia of non-critical patients with T2D in a large multinational, propensity-matched cohort study. A total of 53,516 patients with ICD 9/10 code of T2D were included in the dataset. Patients were categorized as having received SSI only vs. basal insulin, and were matched according to age, BMI, Charlson Comorbidity Index, and admission blood glucose (BG). Among patients with admission BG &lt;180 mg/dL treated with SSI, 69% achieved and maintained good glycemic control (mean hospital BG &lt;180 mg/dl), compared to 52% of patients treated with basal insulin (p &lt;.001). Patients treated with basal insulin had higher rates of hypoglycemia than patients treated with SSI (30 vs. 16%, p &lt;.001). There were no differences in rates of lactic acidosis, acute MI, pneumonia, or bacteremia (p=NS). A total of 14.93% of patients initially treated with SSI alone failed to achieve adequate glycemic control and were started on basal insulin during the hospital stay. Those who failed SSI had significantly higher admission BG (227.4±90 vs. 175.8±71 mg/dl), greater rates of CKD (31 vs. 24%), CHF (29 vs. 24%), CAD (35 vs. 31%), and higher Charlson score (4.3±2.7 vs. 3.8±2.7) than patients who remained well controlled on SSI alone (all, p&lt;.001).
Conclusion: In a multicenter, international, propensity-matched cohort study, 69% of patients with T2D with admission BG &lt;180 mg/dL treated with SSI achieved good glycemic control. Patients admitted with higher BG and greater comorbidities are more likely to fail treatment with SSI alone. These data suggest that SSI may be appropriate for patients with mild/moderate hyperglycemia, thus simplifying recommendations for inpatient glycemic management.

Disclosure
A. Migdal: None. C. Fortin: None. Y. Guo: None. I. Hochberg: None. M.F. Magee: Consultant; Self; Mytonomy. Employee; Spouse/Partner; U.S. Food and Drug Administration. Research Support; Self; AstraZeneca, Eli Lilly and Company, National Institute of Diabetes and Digestive and Kidney Diseases. Speaker’s Bureau; Self; American Diabetes Association, Pri-Med LLC. Other Relationship; Self; Endocrine Society. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. G.E. Umpierrez: None.

Funding
Jacobs Research Foundation
1026-P: Physician-Related Factors Associated with Delay Insulin Initiation in Type 2 Diabetes Mellitus Patients with Oral Antihyperglycemic Agent Treatment Failure
Authors: SITASUWAN TULLAYA , CHOKSAKUNWONG SAWARAJ , SRIVANICHAKORN WEERACHAI 
Published: June 2020

Aims: Despite the availability of numerous glucose-lowering therapies and clear guidelines for T2DM management, only 1/3 of the patient with T2DM in Thailand can achieve their glycemic targets. Timely initiation of insulin therapy has been suggested as one of the strategies to solve this problem. Therefore, the purpose of this study was to identify physician’s attitudes among the internal medicine residents regarding insulin initiation.
Methods: The questionnaire adapting from Physician Attitudes to Insulin Therapy questionnaire was used to conduct a questionnaire-based survey among the internal medicine residents in Siriraj Hospital, Mahidol University.
Results: The questionnaire was sent to 100 internal medicine residents. The response rate was 80%. The majority of respondents (60%, n=48/80) were willing to initiate insulin therapy for the patients with T2DM, who failed oral antihyperglycemic drug (OHD) treatment at HbA1c level between 7.5-9.5%. In addition, 45% (n=36/80) of respondents use HbA1c threshold of above 8.5% to initiate insulin treatment add on to OHD. However, if the internal medicine residents themselves were diabetes mellitus, they would decide to receive insulin at HbA1c level between 7.0-8.5%. The main reasons regarding insulin initiation barrier by physicians were a consideration of burden on the patients and families to initiate insulin therapy (88%, n=70/80), time-consuming for an explanation about insulin devices, monitoring and adjustment (74%, n=59/80) and difficult to advise the patients who fear the injection drugs to use insulin (70%, n=56/80).
Conclusions: Physician-related factors associated with delay insulin initiation need to be addressed for better diabetes management. Internal medicine resident aspects according to high HbA1c thresholds, high effort regarding explanation, and motivation, and the patients and family burdens are the main barriers for insulin initiation.

Disclosure
T. Sitasuwan: None. S. Choksakunwong: None. W. Srivanichakorn: None.
1028-P: Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL (gla-300) in Insulin-Naïve Patients with Type 2 Diabetes (T2DM): Interim Analysis of the ATOS Study
Authors: GALSTYAN GAGIK R. , BHANSALI ANIL , VARGAS-URICOECHEA HERNANDO , TIROSH AMIR , SUN GUANNAN , NAQVI MUBARAK , PILORGET VALERIE , COUDERT MATHIEU , CHERKASOV DMITRY , KHAN NIAZ 
Published: June 2020

ATOS is a prospective, 12-month, observational study assessing real-world effectiveness of the second-generation basal insulin analog Gla-300 in emerging markets. Insulin-naïve adults (≥18 years) with T2DM, HbA1c &gt;7-≤11 % and previously treated with ≥1 oral antihyperglycemic drug were recruited in 18 countries. An interim analysis was undertaken when ≥50% of participants had 6-months’ follow-up data (cut-off July 1, 2019); this included 4527 eligible patients (Eastern Europe: 1748; Egypt: 214; India: 1269; Latin America and Caribbean: 317; Western Asia: 882; Southeast Asia: 46; Taiwan: 51). Mean (SD) age was 57.2 (10.8) years, BMI was 29.4 (5.3) kg/m2, and duration of diabetes was 10.2 (6.2) years; 48.4% were male. Physician-set individualized HbA1c (%) goals at baseline were &lt;7: 13.7%; 7-&lt;7.5: 70.3%; 7.5-&lt;8: 11.9%; ≥8: 4.2%. The proportion of evaluable patients achieving HbA1c goal at Month 6 (primary outcome) was 25.1% (95% CI: 23.6 to 26.6); HbA1c decreases are shown in Table. Hypoglycemia incidence was low (&lt;2%). Treatment-emergent adverse events (TEAEs) were reported in 230 (5.0%) patients, with 47 (1.0%) serious TEAEs (included population). ATOS showed high baseline HbA1c, suggesting delayed insulin initiation; introduction of Gla-300 led to marked improvements in HbA1c with a good safety profile in a real-world setting.

Disclosure
G.R. Galstyan: None. A. Bhansali: None. H. Vargas-Uricoechea: Speaker’s Bureau; Self; Sanofi-Aventis. A. Tirosh: Advisory Panel; Self; Novo Nordisk Inc., Sanofi. G. Sun: None. M. Naqvi: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. M. Coudert: Employee; Self; Roche Pharma, Sanofi-Aventis. D. Cherkasov: None. N. Khan: None.

Funding
Sanofi (ATOS/NCT03703869)