bluuebunny/crossref_metadata_2025_split huggingface dataset:
925-P: Risk of Cardiovascular Events and Serious Hypoglycemia Comparing Patients with Type 2 Diabetes Initiating a GLP-1 Receptor Agonist or Basal Insulin: A Propensity-Score Matched Cohort Study
Authors: LUO JING , PAWAR AJINKYA , WEXLER DEBORAH J. , KIM DAE H. , KIM SEOYOUNG C. , PATORNO ELISABETTA 
Published: June 2020

Prior head-to-head open label trials comparing selected GLP-1RA(s) versus basal insulin(s) did not evaluate cardiovascular outcomes. Using 2 large U.S. commercial claims databases (Optum and Truven MarketScan) from 01/2012 to 12/2017, we assessed the risk of a composite cardiovascular outcome (MI, stroke) and serious hypoglycemia defined by validated claims-based algorithms comparing 26,308 patients with type 2 diabetes (mean age 58, mean HbA1c 8.6%) with prior or concurrent metformin therapy newly initiating an injectable GLP-1RA or basal insulin (Table). We estimated pooled incidence rates, meta-analyzed hazard ratios and 95% CI adjusting for &gt;140 baseline clinical characteristics, including HbA1c. Baseline clinical characteristics were well-balanced in the two groups after 1:1 propensity score matching. In an as-treated analysis, the median follow-up was 148 days. Compared to basal insulin, initiating a GLP-1RA was associated with a lower risk of MI or stroke (HR 0.68 [95% confident interval (CI), 0.51 to 0.90]) and lower risk of serious hypoglycemia (HR 0.38 [95% CI, 0.25 to 0.57]). These results support recent clinical treatment guidelines that recommend starting a GLP-1RA before basal insulin for patients with type 2 diabetes with inadequate glycemic control despite metformin.

Disclosure
J. Luo: Consultant; Self; Alosa Health. A. Pawar: None. D.J. Wexler: Other Relationship; Self; Novo Nordisk A/S. D.H. Kim: None. S.C. Kim: Research Support; Self; AbbVie Inc., Bristol-Myers Squibb. E. Patorno: Other Relationship; Self; Boehringer Ingelheim International GmbH.

Funding
Brigham and Women’s Hospital
928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data
Authors: MODY REEMA , YU MARIA , NEPAL BAL K. , KONIG MANIGE , GRABNER MICHAEL 
Published: June 2020

The objective of this retrospective real-world observational study was to compare 6-month (mo) adherence and persistence among patients (pts) initiating weekly GLP-1 receptor agonists (GLP-1RA), dulaglutide (DU) vs. semaglutide (SEMA) or DU vs. exenatide QW (EQW) BCise pen in the U.S., using claims from the HealthCore Integrated Research Database (HIRD®) between August 2017 and June 2019 (index date=earliest GLP-1RA fill date). Pts ≥18 yrs old, with T2D, no claim for GLP-1 RAs in the 6 mos pre-index period, ≥1 claim for DU, SEMA or EQW during the index period, and continuous enrollment 6 mos pre- and post-index were included. DU users were propensity-matched 1:1 to SEMA (3,852 pairs) or EQW (1,879 pairs) users. Matched cohorts (DU:SEMA/DU:EQW) were balanced in baseline characteristics and the mean age was 54/55 years with approximately 49/51% males, respectively. At 6 mos, DU users were more likely to be adherent [Proportion of Days Covered (PDC)≥80%] than SEMA (odds ratio [OR]=1.986, 95% CI=[1.81, 2.18]) or EQW users (2.06 [1.81, 2.34]) (table). Cox regression showed that DU users were less likely to discontinue therapy than SEMA (hazard ratio [HR]= 0.71, 95% CI=[0.66, 0.76]) or EQW users (0.59 [0.53, 0.65]) (table). At 6-mos follow-up, pts initiating DU had higher medication adherence, and were more persistent to their treatment, compared to pts initiating either SEMA or EQW.

Disclosure
R. Mody: Employee; Self; Eli Lilly and Company. M. Yu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; LifeLabs. Stock/Shareholder; Self; Eli Lilly and Company. B.K. Nepal: None. M. Konig: Employee; Self; Eli Lilly and Company. M. Grabner: Research Support; Self; Eli Lilly and Company.
945-P: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of 12 Once-Weekly Subcutaneous Doses of PB-119 to Patients with Type 2 Diabetes Mellitus as Monotherapy
Authors: XU MIN ,   PEGBIO STUDY GROUP
Published: June 2020

Background: PB119 (polyethylene glycol exenatide) which is a novel once-weekly subcutaneous GLP-1RA, has good pharmacokinetic properties. As a GLP-1RA, it shows a good safety profile and provides solid glycemic control while doesn’t need dose titration. We aimed to assess the efficacy and safety of PB119 monotherapy in Chinese patients with T2DM.
Methods: In this phase 2 study, we randomly assigned 251 patients (1:1:1:1) to receive 3 doses of PB119 (75ug, 150ug, 200ug) or dose-matched placebo using permuted-block randomization, with a block size of 12 and without stratification. Eligible patients were men or women (aged 18-70 years) with T2DM who had a BMI of 18.5-35.0 kg/m², were on a diet and exercise regimen and untreated at least 3 months prior to screening. The study started with a 4-week placebo run-in period followed by a 12-week treatment period. The primary endpoint was the change in HbA1c from baseline to week 12, which was assessed in all patients who received at least 1 dose of study drug and had both baseline and at least 1 post-baseline HbA1c value. Safety was assessed in all patients who received at least 1 dose of study drug. ClinicalTrials.gov NCT03520972.
Findings: At the end of week 12, the least squares mean change in HbA1c from baseline was -0.39% (95% CI -0.60 to -0.19) in the placebo group, -1.11% (-1.32 to -0.91) in the 75ug group, -1.57% (-1.78 to -1.37) in the 150ug group and -1.41% (-1.61 to -1.20) in the 200ug group. Compared with the placebo group, the change in HbA1c between baseline and week 12 was significant in all PB119 (p&lt;0.001) groups. Significant reductions in TC and TG were observed in 150ug and 200ug groups (P&lt;0.05), while the reductions in body weight and LDL-C were significant in 200ug group (P&lt;0.05). There were no reports of drug-related serious adverse events or severe hypoglycemia.

Disclosure
M. Xu: None.
946-P: The GLP-1 Receptor Agonist GL0034 Activates Central Regions Controlling Glucose Homeostasis and Feeding Behavior
Authors: PICARD ALEXANDRE , TARUSSIO DAVID , THENNATI RAJAMANNAR , BURADE VINOD S. , THORENS BERNARD 
Published: June 2020

Background: GL0034 is a novel glucagon-like peptide-1 receptor (GLP-1R) agonist showing glucose-lowering effects with increased insulin and C-peptide levels, reduced plasma glucagon levels, long-term reduction in HbA1C, and reduced body weight when tested in type 2 diabetic mice. At equivalent doses, these effects were significantly higher than those obtained with other GLP-1R agonists used clinically. We evaluated whether GL0034 administration activated brain regions involved in the control of energy homeostasis, which could explain the beneficial effects of this agonist.
Methods: C57BL/6 mice received SC injections of saline, GL0034 (12 or 24 nmol/kg), or semaglutide (12 or 24 nmol/kg). The mice were euthanized 2 hours after dosing and their brains were fixed with paraformaldehyde. Cryosections were prepared from the entire brain; c-fos expression was assessed by immunohistochemistry.
Results: We observed induction of c-fos expression in response to GL0034 SC injections in the area postrema and the nucleus tractus solitarius of the dorsal vagal complex and in the parabrachial nucleus and locus coeruleus. Lower levels of c-fos expression were detected in the central amygdala, subfornical organ, vascular organ of the lamina terminalis, and ventromedial preoptic nucleus. No significant staining could be observed in the hypothalamus, including the arcuate nucleus and the dorsomedial hypothalamus. These results were qualitatively comparable after GL0034 and semaglutide SC injections.
Conclusion: These results indicate that SC injection of GL0034 activates several central brain regions, which control energy homeostasis through regulation of autonomic nervous activity and feeding behavior, potentially impacting food preference and motivated feeding behavior. These central effects may combine with the direct stimulation of pancreatic beta cells and insulin secretion by GL0034 to ensure efficient control of glucose homeostasis.

Disclosure
A. Picard: None. D. Tarussio: None. R. Thennati: None. V.S. Burade: Employee; Self; Sun Pharmaceutical Industries Ltd. B. Thorens: Other Relationship; Self; Servier.
954-P: GLP-1–Experienced Patients Switching to Once-Weekly Semaglutide in a Real-World Setting (EXPERT Study)
Authors: LINGVAY ILDIKO , KIRK ANDREAS ROSS , LOPHAVEN SØREN , WOLDEN MICHAEL L. , SHUBROOK JAY H. 
Published: June 2020

Introduction: The effect of once-weekly (OW) subcutaneous semaglutide, a glucagon-like peptide-1 (GLP-1) analog for the treatment of T2D, has been examined in GLP-1-naïve patients only. Here, we examined glycemic control and weight management in GLP-1-experienced patients switching from another GLP-1 to semaglutide in a real-world setting, using U.S. prescription data.
Methods: Adults (≥18 years old) with T2D were identified in the Explorys (IBM Watson Health) U.S. electronic medical records database (data cut-off 12/5/19). Included patients had ≥1 prescription for semaglutide (index/switch date), a prescription for any other GLP-1 (baseline) in the previous year, and separate HbA1c/weight measurements at 6 or 12 months post-index and in the 90-day pre-index period.
Results: Patients with valid HbA1c (N=365) and weight (N=480) data had similar baseline characteristics. Both the full 6-month cohorts and subgroups with 12-month data had significant HbA1c and weight reductions (Figure). Significant HbA1c improvement at 6 months was sustained at 12 months, whereas weight loss was more pronounced with longer follow-up. HbA1c and weight changes were independent of previous GLP-1 used (p&gt;0.05 between GLP-1s).
Conclusions: Switching to OW semaglutide from another GLP-1 was associated with significant HbA1c and weight reductions in routine clinical practice, independent of previous GLP-1 used.

Disclosure
I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S. A. Kirk: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. S. Lophaven: Consultant; Self; Novo Nordisk A/S. M.L. Wolden: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. J.H. Shubrook: Advisory Panel; Self; Bayer U.S., Eli Lilly and Company, Novo Nordisk Inc., Sanofi US.

Funding
Novo Nordisk A/S
976-P: Evaluation of Hybrid Closed-Loop Insulin Delivery System for Patients with Type 1 Diabetes in Real-World Clinical Practice: A One-Year Qualitative Observational Study
Authors: ELDIB AHMED H. , TOMAH SHAHEEN , DHAVER SHILTON E. , GARDNER HANNAH , TASABEHJI MHD WAEL , ALBADRI MARWA , ATAKOV-CASTILLO ASTRID , TOSCHI ELENA , HAMDY OSAMA 
Published: June 2020

The MiniMed™ 670G (670G) is the first FDA approved hybrid closed-loop insulin delivery system for patients with type 1 diabetes (T1D). In Auto Mode, the integrated continuous glucose monitor (CGM) captures glucose values every five minutes and, via a built-in algorithm, the 670G system automatically adjusts basal insulin delivery targeting a glucose value of 120 mg/dL. Impact of the use of 670G system on patient reported outcomes in people with T1D are limited. Data over one year of use in real world-clinical practice were collected. We evaluated 53 patients with T1D (mean age 46.8±11.8 years, 62% females, body weight 82.5±17.6 kg, BMI 28.7±5.5, HbA1c 7.6±0.8%) who started 670G at the Joslin Clinic between December 2017 and December 2019. Data were collected at baseline and after 12 months. We assessed SROs by administering surveys: 36 Item Short-Form Health Survey (SF 36), Pittsburgh Sleep Quality Index (PSQI), and hypoglycemia fear survey/worry scale (HFS_W). We also measured HbA1c, % time-in-range at baseline and 12 months, and % time in auto mode (TiAM) for the two weeks preceding the final study visit. At 12 months, A1C decreased by 0.3±0.1% from baseline (p&lt;0.01) and % time-in-range increased by 7.9±3.1% from baseline (p=0.015) with no correlation between either of them and %TiAM (p=0.3, p=0.2 respectively). Physical functioning increased by 47.5% from baseline (p&lt;0.001), and HFS_W improved significantly by -16.0% from baseline (p=0.017). At 12 months, average %TiAM was 60.4±33.7% and was not associated with clinical outcomes or SROs. We conclude that use of 670G for a year in real-world clinical practice was associated with significant improvement in A1C, % time-in-range, physical functioning and hypoglycemia fear. Neither of these improvements at 12 months was related to %TiAM.

Disclosure
A.H. Eldib: None. S. Tomah: Stock/Shareholder; Self; Amarin Corporation. S.E. Dhaver: None. H. Gardner: None. M. Tasabehji: None. M. Albadri: None. A. Atakov-Castillo: None. E. Toschi: None. O. Hamdy: Consultant; Self; Abbott, AstraZeneca, Merck & Co., Inc., Sanofi-Aventis. Research Support; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Healthimation, LLC.
Individual and Combined Associations of Modifiable Lifestyle and Metabolic Health Status With New-Onset Diabetes and Major Cardiovascular Events: The China Cardiometabolic Disease and Cancer Cohort (4C) Study
Authors: Li Mian , Xu Yu , Wan Qin , Shen Feixia , Xu Min , Zhao Zhiyun , Lu Jieli , Gao Zhengnan , Chen Gang , Wang Tiange , Xu Yiping , Zhao Jiajun , Chen Lulu , Shi Lixin , Hu Ruying , Ye Zhen , Tang Xulei , Su Qing , Qin Guijun , Wang Guixia , Luo Zuojie , Qin Yingfen , Huo Yanan , Li Qiang , Zhang Yinfei , Chen Yuhong , Liu Chao , Mu Yiming , Wang Youmin , Wu Shengli , Yang Tao , Chen Li , Yu Xuefeng , Yan Li , Deng Huacong , Ning Guang , Bi Yufang , Wang Weiqing 
Published: June 2020

OBJECTIVE
We aimed to determine the individual and combined associations of lifestyle and metabolic factors with new-onset diabetes and major cardiovascular events among a Chinese population aged ≥40 years.

RESEARCH DESIGN AND METHODS
Baseline lifestyle information, waist circumference, blood pressure, lipid profiles, and glycemic status were obtained in a nationwide, multicenter, prospective study of 170,240 participants. During the up to 5 years of follow-up, we detected 7,847 individuals with new-onset diabetes according to the American Diabetes Association 2010 criteria and 3,520 cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and hospitalized or treated heart failure.

RESULTS
On the basis of 36.13% (population-attributable fraction [PAF]) risk attributed to metabolic risk components collectively, physical inactivity (8.59%), sedentary behavior (6.35%), and unhealthy diet (4.47%) moderately contributed to incident diabetes. Physical inactivity (13.34%), unhealthy diet (8.70%), and current smoking (3.38%) significantly contributed to the risk of major cardiovascular events, on the basis of 37.42% PAF attributed to a cluster of metabolic risk factors. Significant associations of lifestyle health status with diabetes and cardiovascular events were found across all metabolic health categories. Risks of new-onset diabetes and major cardiovascular events increased simultaneously according to the worsening of lifestyle and metabolic health status.

CONCLUSIONS
We showed robust effects of lifestyle status on new-onset diabetes and major cardiovascular events regardless of metabolic status and a graded increment of risk according to the combination of lifestyle and metabolic health, highlighting the importance of lifestyle modification regardless of the present metabolic status.
PENGARUH SISTEM OLAH TANAH DAN PEMBERIAN MULSA ORGANIK TERHADAP ALIRAN PERMUKAAN DAN EROSI PADA PERTANAMAN KACANG HIJAU (Vigna radiata) MUSIM TANAM KE EMPAT DI LABORATORIUM LAPANG TERPADU FAKULTAS PERTANIAN UNIVERSITAS LAMPUNG
Authors: Jaya Ahmad Shan Kemala , Banuwa Irwan Sukri , Novpriansyah Hery , Utomo Muhajir 
Published: June 2020

Tillage can significantly affect soil susceptibility to erosion which can accelerate and increase the rate of erosion. The use of mulch can reduce erosion by reducing the impact energy of falling rain so it does not damage the structure and aggregate of the soil, reducing speed, volume and scouring of surface runoff. This study aims to determine the effect of (1) tillage systems on surface runoff and erosion in green bean plant (2) applying organic mulch to the amount of surface runoff and erosion in green bean plant (3) the interaction between the tillage system and the use of mulch on surface runoff and erosion in green bean plant . This research was conducted in March to June 2017 in the Integrated Field Laboratory of the Faculty of Agriculture, University of Lampung. The design used is factorial in the Complete Randomized Block Design (RCBD) on two treatment factors namely the tillage system and the mulch with four replications. The results showed that the tillage system did not significantly affect all observed variables. In the treatment of giving and without mulch also did not significantly affect all observed variables. The response of surface runoff and erosion in green bean plant to the tillage system does not depend on the organic mulch shown on all variables.
POPULASI DAN TINGKAT SERANGAN HAMA KUTU PUTIH PADA UBI KAYU (Manihot esculenta Crantz) PADA BEBERAPA LOKASI PENANAMAN	DI LAMPUNG
Authors: Sidarlin Sidarlin , Swibawa I Gede , Hariri Agus Muhammad , Susilo FX 
Published: June 2020

The research aimed at studying the level of attack and population of mealybug cassava in multiple cassava planting locations in Lampung Province takes place from September 2017 to January 2018. Sampling was carried out in several cassava planting locations in five villages in five sub-districts in South Lampung, Central Lampung, and East Lampung. Attack crop samples were ten plants that were systematically chosen, each at five sample points located on four diagonal lines and one at the midpoint of each field. One plant at each sample point was selected for observation of the mealybug population. The laboratory process is carried out at the Plant Pests Laboratory, Plant Protection Department, Faculty of Agriculture, University of Lampung. The results showed that mealybug were found in all locations of observation with a low population density of 0.68-3.26 individuals. per 3 leaves. Location of cassava planting does not affect the population of mealybug but this location affects crop damage which ranges from 47 - 59%. Damage to plants in South Lampung is lower than damage to plants in East Lampung and Tanjung Bintang.
Implementation of Oxymetry Sensors for Cardiovascular Load Monitoring When Physical Exercise
Authors: Tisna Dhodit Rengga , Al Rasyid M. Udin Harun , Sukaridhoto Sritrusta 
Published: June 2020

The performance condition of an athlete must always be maintained, one way to maintain that performance is by training. Each individual has different abilities and physiological responses in receiving the portion of the exercise. Physical exercise that exceeds the body's ability can worsen the condition of the athlete itself which can result in excessive fatigue (overtraining) or can even result in injury. Therefore a system is needed to monitor the condition of the physiological response when given the intensity of the training load so that the portion of the training provided provides positive benefits for the athlete. This system was developed using an oxymetry sensor, microcontroller and wifi module ESP8266. This system is used to collect heart rate and oxygen saturation data, then with the existing formula the heart rate value is converted to a CVL (Cardiovascular Load) value to determine the level of fatigue in athletes when given the intensity of the training load. By using a web-based application, measurement data is displayed in realtime to make it easier to see the results of monitoring. From the experimental results the system can monitor changes in the physiological condition of the athlete when given the intensity of the training load. Finally, the developed system can collect athlete's physiological data, and can store the data in a database and display it in a web application.
Eligibility Study on Floating Solar Panel Installation over Brackish Water in Sungsang, South Sumatra
Authors: Sasmanto Andri Agus , Dewi Tresna , Rusdianasari  
Published: June 2020

Electric generation using the photovoltaic (PV) effect is considered ideal in South Sumatra as a response to the government policy to increase the utilization of renewable energy to support the depletion of conventional energy. PV panels can be installed in a fishing village in the Sungsang Estuary. This paper examined the eligibility analysis for the installation of PV panels on brackish water. In this research, two Panels are installed, the first one is floating over a water body, and the second is ground mounted as a comparison of electricity produced and efficiency. The Jsc floating and ground mounting differ in 0.4435 A. The measured Jload in floating PV panels is 0.3900 A higher than the ground mounting. The measured Voc at the floating PV panels is 0.2935 V higher, and the Vload of the floating PV panel is 3.0742 V higher than the ground mount. The differences are due to the floating PV panel surface temperature being lower than ground mounting. Electricity generated by floating PV panels is averagely 11.89 Watt higher, and the efficiency is 4% higher than that of ground installation. This experiment also shows that PV panels can be installed over brackish water in the fishing village of Sungsang Estuary.
Formulasi Pengaturan Tahapan Pra Kontrak dalam Proses Pembentukan Kontrak di Indonesia
Authors: Ardyo Bebeto 
Published: June 2020

The increasement of human needs in society goes hand in hand with the development of technology. To meet these needs, there must be interaction between people which sometimes has the potential to cause disputes. That’s why a contract is needed. The existence of a contract guarantees legal certainty regarding protection of the rights of the parties and also the obligations that they must fulfill. There are several stages of contract formation which consist of pre-contract and agreement between the parties. According to the system in the Book III of Indonesia’s Code of Civil Law, consensus is the base for the formation of contract that means once the agreement has reached between the parties then a contract is formed. Indonesia’s Code of Civil Law doesn’t yet regulate pre-contract stages of contract formation, even though these stages are equally important. The regulation of pre-contract stages are usually set in the common law system, but along with the times, the regulation of pre-contract stages should also be regulated in the civil law system. As a comparison, Het Nieuw Burgerlijke Wetboek (New Civil Code of Netherlands) has already regulated that pre-contract stages, although the Netherlands is a country that implements civil law system. The pre-contract stages are very important to be regulated in Indonesia because there are many potential pre-contractual issues. This paper aims to formulate the outline of what needs to be regulated in the pre-contract regulations.
Keywords : Interaction, Contract, Formation, Civil Code