Sanofi China Research Articles

1437-P: Treatment Pattern and Glycemic Control of Adults with T2DM in Northern China

Aim: To better understand the current treatment pattern and glycemic control status in Chinese adults with T2DM. Methods: A retrospective study was conducted among adult T2DM patients using electronic medical records from 2015 to 2019 in Tianjin, a metropolis in Northern China. Results: From 2015 to 2019, a total of 312,203 patients from 75 hospitals were included, with mean age of 61.9 years old and BMI 26.1 kg/m2. HbA1c decreased from 8.2% to 7.9% with the percentages of HbA1c <7% increased from 28.1% to 33.7% (P<0.001). A growing proportion treated with basal insulin and GLP-1RA ± basal insulin was seen while the proportion of premixed insulin decreased (P<0.001). 44.0% of the subjects were treated with OAD only and the most frequently used OADs were α-glucosidase inhibitor (55.7%) and metformin (47.0%). The percentages of cardiovascular risk factors and macrovascular events including hypertension, dyslipidemia, obesity, cardiovascular disease and stroke were increased each year (P<0.001). During 2015-2019, 27.7% and 40.3% of the population had FPG<7 mmol/L and PPG<10 mmol/L, respectively, while 46.1% of them had both FPG ≥ 7 and PPG ≥10 mmol/L. Conclusion: From 2015 to 2019, an increasing proportion of T2DM population achieved HbA1c target, reflecting the potential optimized treatment concept and regimen. Meanwhile, there is still room to improve the holistic management of T2DM in China for a better patient outcome. Disclosure L.Chen: None. L.Kang: Employee; Sanofi China. M.Li: None. Q.Zhang: None. Y.Fan: None. X.Liu: None. M.Zhang: Employee; Sanofi China. G.Wu: Employee; Sanofi China. M.Wu: Employee; Sanofi China. Q.Huang: Employee; Sanofi China. Y.Han: Employee; Sanofi China. Funding Sanofi

703-P: Community-Based Peer Support for Diabetes Management—Impacts Relative to Comparison Communities

Community-based Peer Leader (PL) program in 12 PL communities (PLCs) was compared to 4 Comparison Communities (CCs) in Shanghai, China from 2019 to 2021. Key collaborators included district and sub-district health promotion offices, community health centers (CHCs), community self-management groups, and neighborhood committees. Implementation assessment indicated community adaptation of standardized intervention components: public education about diabetes, neighborhood activities, diabetes education classes, diabetes management meetings, follow-up with individuals and families, and online communication via WeChat due to COVID disruptions. Among those with baseline and follow-up data (n = 1066), PLCs (n = 799) and CCs (n = 267 in 4 CCs) differed significantly on age (66.4 vs 63.7 years), gender (56.8% vs 46.4% female), diabetes duration (8.0 vs 6.5 years), and BMI (25.3 vs 26.0 kg/m2) (all ps ≤ 0.009). Controlling for these and baseline levels of HbA1c, reductions of HbA1c favored the PLCs (-0.06±1.27 vs 0.22±1.56, p < 0.001). Parallel analyses showed significant reductions favoring PLCs for FPG (-0.04±2.50 vs 0.76±2.84, p < 0.001), a 4-item measure of diabetes distress (-0.07±0.41 vs 0.06±0.37, p = 0.004), and depressive symptoms (PHQ-8) (-0.49±3.21 vs 0.54±2.73, p = 0.002). Among those with elevated baseline levels, greater reductions for PLC vs CC were observed for those with HbA1c ≥ 8% at baseline (-0.76±1.56 vs -0.41±2.09, p = 0.038) and those with FPG > 7 mmol/L (-0.54±2.93 vs -0.06±2.95, p = 0.007). Significant PLC vs CC differences were not observed for SBP, DPB, or general quality of life (EQ5D). A slight difference in change of LDLc favored CCs (-0.28±0.90 vs -0.38±0.86, p = 0.042) but only for those with elevated LDLc ≥ 2.6 mmol/L. Community organization of PL for diabetes management implemented through community groups and CHCs showed greater changes in glucose control, diabetes distress, and depressive symptoms compared with comparison groups. Disclosure Y.Liu: None. C.Cai: None. X.Wu: None. P.Y.Tang: None. M.M.Coufal: None. L.Shen: None. E.B.Fisher: Advisory Panel; Eli Lilly and Company, Research Support; Merck Sharp & Dohme Corp. W.Jia: None. Funding Chinese Academy of Engineering (2022-XY-08); Shanghai Municipal Science and Technology Commission (22692114600); Shanghai Municipal Grant (GWIV-3.1); Shanghai Municipal Health Commission (20194Y0141, JKKPYC-2022-12); Merck Foundation; Sanofi China; National Institute of Diabetes and Digestive and Kidney Diseases (P30 DK092926)

1373-P: The Prevalence and Risk Factors of Chronic Kidney Disease in Patients with Type 2 Diabetes in China—A Cross-Sectional Study

Chronic Kidney Disease (CKD) is a major long-term complication of diabetes and the leading cause of end-stage kidney disease worldwide. It has become very important to regularly screen for early renal disease and rationally use medicines in patients with diabetes and CKD. This was a cross-sectional study, an analysis of baseline data from an ongoing prospective multicenter cohort study, ClinicalTrials.gov ID: NCT05047471. The subjects were outpatients and inpatients from 45 hospitals participating in the endocrinology department from December 2021 to September 2022. Univariate and multivariate binary logistic regression were used to identify risk factors correlated to CKD in patients with type 2 diabetes (T2D). A total of 9886 patients with T2D met our inclusion criteria, please refer to table 1 for the baseline characteristics. The prevalence, screening rate, and awareness rate of CKD was 32.5% [95%CI 31.6, 33.4], 55.3% [95%CI 54.3, 56.3], and 26% [95%CI 24.5, 27.6], respectively. The risk factors independently associated with CKD in patients with T2D were age, duration of T2D, hypertension, LDL-C elevated, poor glycemic control, diabetic foot, diabetic retinopathy, diabetic neuropathy etc., shown in table 2. This work will be helpful in promoting the standardized diagnosis and treatment of CKD in patients with T2D in China, and in arousing the attention of patients with T2D to CKD. Disclosure D.Zhu: None. Y.Mu: Speaker's Bureau; Abbott Diabetes, Boehringer Ingelheim Inc., Novo Nordisk (China), Sanifit. L.Shi: None. Y.Xue: None. X.Yu: None. Y.Wang: None. T.Hong: Speaker's Bureau; Novo Nordisk (China), Sanofi China, Eli Lilly and Company, Merck Sharp & Dohme Corp., Merck & Co., Inc., Boehringer Ingelheim Inc., AstraZeneca, Bayer Inc. X.Li: None. J.Ma: None. Funding Beijing Great Physician Commonwealth Foundation (DYJ20210621)

850-P: Greater HbA1c Reduction with iGlarLixi vs. Insulin Glargine and Lixisenatide Regardless of Levels at Screening: Subgroup Analysis of the LixiLan-O Asia Pacific Trial

Introduction: LixiLan-O-AP (NCT03798054) showed greater HbA1c improvement with iGlarLixi vs. iGlar or Lixi in Asian Pacific adults with type 2 diabetes (T2D) . This pre-defined analysis assessed iGlarLixi efficacy by HbA1c levels at screening. Methods: Adults (N=878) with suboptimally controlled T2D (HbA1c of 7.5-% or 7-% depending on background oral antihyperglycemic drug [OAD] use) on metformin ± a second OAD were randomized 2:2:1 to iGlarLixi, iGlar or Lixi for 24 weeks. Three screening HbA1c subgroups were defined: <8, 8-<9, ≥9 %. Results: At Week 24, in all HbA1c subgroups, iGlarLixi was associated with greater HbA1c reductions vs. iGlar or Lixi and reached mean HbA1c levels <7 %. iGlarLixi also showed greater 2-h postprandial glucose reductions, and a higher proportion of participants reaching HbA1c <7 % and HbA1c <7 % without weight gain, vs. iGlar or Lixi (Table) . Incidence and rates of documented hypoglycemia ≤70 mg/dL (≤3.9 mmol/L) were similar between iGlarLixi and iGlar in the 8-<9 % and ≥9 % subgroups but were slightly higher with iGlarLixi vs. iGlar in the <8 % subgroup. Conclusions: Regardless of HbA 1c level at screening, iGlarLixi demonstrated better glycemic control vs. iGlar or Lixi, with over 75% of participants achieving the recommended target HbA 1c (<7 %) with iGlarLixi, even those with HbA1c ≥9 % at screening. Disclosure Y. He: None. W. Yang: Other Relationship; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Mer, Merck Sharp & Dohme Corp., Novo Nordisk, Sanofi-Aventis Deutschland GmbH, Servier Laboratories. M. Liu: None. J. Xiao: None. S. Gu: Employee; Sanofi China. L. Chen: None. E. Souhami: Employee; Sanofi. Stock/Shareholder; Sanofi. Funding Funding: Sanofi

721-P: Efficacy and Safety of Basal-First Titration Order in Patients with Type 2 Diabetes (T2D) Receiving Short-Term Intensive Insulin Therapy (SIT)

To titrate basal and bolus insulin sequentially or simultaneously during SIT remains controversial. Here we report an easy titration order verified in a 7-10 day SIT period. Insulin naive Chinese T2D adults receiving stable doses of metformin and 1-2 oral antihyperglycemic drugs with HbA1c 7.5%-11.0% were treated with once-daily insulin glargine 100 U/mL (Gla-100) and thrice-daily insulin glulisine (Glu) for 7-10 days titrated to achieve a fasting blood glucose (FBG) In conclusion, when starting basal-bolus regimen in SIT, basal-first titration order was effective, fast to target and well tolerated in Chinese T2D patients. Disclosure L. Guo: Consultant; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., BD, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk, Sanofi China. J. Liu: Employee; Self; Sanofi China. X. Zhang: None. N. Cui: Employee; Self; Sanofi China. H. Yin: None. Y. Mu: Speaker’s Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi-Aventis. H. Wan: None. J. Wang: None. B. Xu: None. G. Wang: None. C. Jiang: None. L. Liang: None. W. Feng: Employee; Self; Sanofi China. Funding Sanofi China (NCT03359837)

1052-P: Clinical Characteristics of Osteoporosis in Postmenopausal Women with Type 2 Diabetes Mellitus

Objective: To investigate clinical characteristics and risk factors of osteoporosis in postmenopausal women with type 2 diabetes mellitus. Method: A total of 410 postmenopausal women with type 2 diabetes of natural menopause with no history of fracture were collected from outpatients of Beijing Hospital (Oct 2017 - Nov 2019). Bone mineral density (BMD) at lumbar spine L1-L4 and hip was measured using dual-energy X-ray absorptiometry. Biochemical markers of bone and glucose metabolism were evaluated. Patients were divided into three groups based on BMD: A (osteoporosis): T ≤-2.5 SD; B (osteopenia) -2.5 < T ≤ -1 SD; C (normal bone mineral density) T > -1 SD. Statistical differences of age, menopausal age, diabetes age, BMI and biochemical indexes were compared between groups. Result: 1. Case number based on lumbar spine BMD: 189 in A (46.1%), 147 in B (35.9%), and 74 in C (18.0%). ANOVA analysis showed group A patients had the highest age (F 5.698, p 0.004), age of diabetes onset (F 7.596, p 0.001), ALP (F 3.231, p 0.041) and menopausal duration (F 7.596, p 0.001), but the lowest BMI (F 11.456, p 0.000). Logistic multivariate regression showed body mass index is an independent risk factor for osteoporosis in postmenopausal women with type 2 diabetes [A vs. C: OR1.224 (95% CI 1.106-1.355, p 0.000); A vs. B: OR1.172 (95% CI 1.079-1.274, p 0.000].2. Case number based on femoral neck BMD: 159 in A (38.8%), 188 in B (45.9%), 63 in C (15.3%). ANOVA analysis showed group A patients had the highest age (F 21.484, p 0.000), age of diabetes onset (F 10.125, p 0.000) and PTH (F3.691, 0.026), but the lowest BMI (F 11.456, p 0.000). Logistic multivariate regression showed body mass index is an independent risk factor for osteoporosis in postmenopausal women with type 2 diabetes [A vs. C: OR1.267 (95% CI 1.120-1.433, p 0.000); A vs. B: OR1.195 (95% CI1.099-1.301, p 0.000)]. Conclusion: Osteoporosis in postmenopausal women with type 2 diabetes is associated with older age, longer menopause duration, older age of diabetes onset and lower BMI. Disclosure Y. Wang: None. Z. Lina: None. L. Guo: Consultant; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., BD, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk, Sanofi China.

416-P: Palmitic Acid-Induced Schwann Cells Apoptosis and Oxidative Stress in Diabetes Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetes, but its pathogenesis has not been fully clarified. Schwann cells play an indispensable role in maintaining the structure and function of neurons, but the mechanism is complex. High fatty acid is the characteristic of diabetic complications. We used RSC96 to investigate the effects of palmitic acid on apoptosis and mitochondrial function. Our results showed increased ROS production and mitochondrial oxidative stress, increased apoptosis, and decreased ATP generation. DPN was aggravated by Schwann cell apoptosis, oxidative stress and mitochondrial dysfunction. Although the interaction between Schwann damage and neuronopathy remains to be elucidated, the present study may provide ideas for novel pathogenetic pathways of DPN.View largeDownload slideView largeDownload slideView largeDownload slideView largeDownload slideDisclosureJ. Fan: None. L. Guo: Consultant; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., BD, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk, Sanofi China.

2164-PUB: Community Expansion of Peer Support for Diabetes Management in Shanghai

Peer support can be effective but dissemination is a challenge. In the context of the Shanghai Integration Model linking specialty/hospital with primary/community care, trained volunteer peer leaders (PLs) based in 9 Community Health Centers (CHCs) implemented peer support. Results included improved glycemic control and reduced BMI, diabetes distress and depression, each more pronounced among those with poorer baseline status. Benefit varied however according to CHCs’ ability to organize peer support. Dissemination needs to recruit additional agencies to support CHCs. Accordingly, a current phase includes additional government and citizen-led organizations in an additional 12 of Shanghai’s 240 communities. District-level and sub-district or community health staff work with each community’s CHC as well as citizen led Community Self Management Groups (> 5,000 in Shanghai) and government affiliated, local Residential Committees. Reports through regular monitoring and meetings with CHC and community staff during the first 8 months (May-December, 2019) indicate CHC and community staff work together in a complementary manner. CHC staff take responsibility for diabetes education (e.g., teaching 6 basic diabetes education modules) and designing activities. Community staff organize or facilitate activities, e.g., the 6 modules, cooking events, discussion groups, or recreational activities that provide a sense of solidarity among those with diabetes. District-level staff coordinate key responsibilities, integrate resources, organize large-scale activities, and train community level groups. Other community organizations include, e.g., an NGO in one district with extensive experience in community services. Across the 12 communities, an average of 6.33 PLs have been trained not including community groups that lead activities. Communities have held an average of 14.08 classes drawing from the 6 diabetes education modules. Disclosure Y. Liu: None. P.Y. Tang: Research Support; Self; Merck Foundation. Y. Qian: None. M.M. Coufal: None. E.B. Fisher: Research Support; Self; Merck Foundation, Sanofi China. W. Jia: None. Funding Shanghai Municipal Grants (GWIV-3.1 to W.J.); Shanghai 6th People’s Hospital (YNLC201812 to Y.L.); Shanghai Municipal Health Commission (20194Y0141 to Y.L.); Merck Foundation; Sanofi China; Michigan Center for Diabetes Translational Research; National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092926)

736-P: Diabetes Distress and Depression Are Reduced through Neighborhood Support in Peer Support Program in Shanghai

Depression and diabetes distress (DD) are both important features of diabetes in China, as in other countries. A study of Chinese adults with type-2 diabetes, e.g., found 42% prevalence of moderate/high levels of DD. Here we examine whether peer support may increase neighborhood support and whether changes in neighborhood support may be associated with changes in depression and DD in Shanghai. In extension of the Shanghai Integration Model that links specialty/hospital care with primary care, trained volunteer peer leaders (PL) implemented varied supportive activities in 9 Community Health Centers (CHCs). In addition to diabetes education, PLs led activities to increase sense of solidarity among participants, such as walking or dance clubs. Neighborhood support for diabetes management was measured by 8 items (e.g., “other people understand the importance of diabetes management”) in an evaluation sample of 1284 before and after 12 months’ PL activity. Research staff unaware of outcomes rated the number of PLs working from each CHC and the extent to which they led activities and contacted individuals. Combining these ratings, PL activity predicted increased neighborhood support (ß = 0.187, p < 0.001, controlling for baseline neighborhood support, gender, age, education, years with diabetes, and clustering within sites). Increases in neighborhood support in turn were associated with decreased DD and depression (partial correlations = -0.170 and -0.161, ps < 0.001, controlling for gender, etc., baseline neighborhood support and baseline DD and depression, respectively). Neighborhood support may be an important path through which peer support programs reduce DD and depression. Research suggests Chinese individuals with diabetes experience DD in culturally unique ways. Further research might examine how benefits of peer and neighborhood support for DD and depression may also reflect Chinese culture and suggest approaches to tailoring peer support for other cultures. Disclosure E.B. Fisher: Research Support; Self; Merck Foundation, Sanofi China. Y. Qian: None. P.Y. Tang: Research Support; Self; Merck Foundation. Y. Liu: None. M.M. Coufal: None. W. Jia: None. Funding Shanghai Municipal Grants (GWIV-3.1 to W.J.); Shanghai 6th People’s Hospital (YNLC201812 to Y.L.); Shanghai Municipal Health Commission (20194Y0141 to Y.L.); Merck Foundation; Sanofi China; Michigan Center for Diabetes Translational Research; National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092926)

666-P: Predictors and Effects of Participation in Peer Support: A Prospective Structural Equation Modeling Analysis

Peer support provides benefits across varied health concerns. As opposed to simple offer of support, however, predictors of and importance of levels of participation are not well understood. Analyses of 7 peer support interventions, with 1,612 participants address these questions, first identifying characteristics that predict participation, and then examining whether, controlling for those characteristics, participation itself predicts benefit, using reduced HbA1c as an indicator of benefit. From the U.S. (5 sites), Hong Kong, and the UK, interventions shared emphases on peer supporters helping adults with type 2 diabetes improve disease management. Common data included pre/post hemoglobin A1c (HbA1c), contacts of participants with peer supporters, health literacy, availability/satisfaction with support for diabetes management from family/clinical team, and gender, age, education, and years with diabetes. From structural equation modeling, significant findings indicated 1) older age and lower levels of support for diabetes management predicted more contacts with peer supporters, and 2) more contacts predicted lower levels of final HbA1c. Effects of contacts on HbA1c included those with baseline HbA1c > 7.5% or > 9%. No contacts and tertiles of low, moderate, and high contacts showed a linear, dose-response relationship with final HbA1c (p < 0.001). Baseline and covariate-adjusted, final HbA1c was 8.19% versus 7.85% for those with no and high contacts, respectively. Among those using insulin (29.7%), only those in the high group achieved greater benefit than those with no contacts. Reflecting other findings that peer support reaches/benefits those at greater disadvantage, those reporting less social support for diabetes management were more likely to participate in peer support. Participation in turn predicted better glycemic control across levels of baseline glycemic control and in a dose response relationship across levels of participation. Disclosure G.X. Ayala: None. J.C. Chan: None. A. Cherrington: None. J.P. Elder: None. E.B. Fisher: Research Support; Self; Merck Foundation, Sanofi China. M. Heisler: None. A. Howard: None. H. Parada: None. M. Safford: None. D. Simmons: None. T.S. Tang: None. Funding Merck Foundation; Eli Lilly and Company Foundation; Bristol-Myers Squibb Foundation

Meta-Analysis and Cost-Effectiveness Analysis of Insulin Glargine 100 U/mL Versus Insulin Degludec for the Treatment of Type 2 Diabetes in China.

To evaluate the efficacy and safety as well as the long-term cost-effectiveness of insulin glargine 100 U/mL (IGlar) versus insulin degludec (IDeg) for the treatment of type 2 diabetes mellitus (T2DM) from the Chinese healthcare system perspective. A systematic search of English and Chinese electronic databases for randomized controlled trials (RCTs) comparing IGlar with IDeg for the treatment of T2DM was performed, followed by a meta-analysis to compare the efficacy and safety of IGlar versus IDeg. The CORE Diabetes Model was used to estimate lifetime costs, quality-adjusted life years (QALYs) gained, and cost-effectiveness of IGlar versus IDeg. One-way and probabilistic sensitivity analyses were conducted to assess the underlying parameter uncertainty. Six RCTs were included in the meta-analysis. The IGlar group showed a statistically significant decrease in glycated hemoglobin (HbA1c) from baseline compared to the IDeg group (mean difference [MD] 0.08%, 95% confidence interval [CI] 0.01-0.14%, P = 0.02). Body mass index (BMI) control was numerically better in the IGlar group than in the IDeg group (MD 0.07kg/m2, 95% CI - 0.01 to 0.14kg/m2, P = 0.08). In terms of hypoglycemia, the incidence of non-severe overall hypoglycemia was comparable between the IDeg and IGlar patient groups (P > 0.05), while the incidence of non-severe nocturnal hypoglycemia (relative risk [RR 0.79], 95% CI 0.70-0.90, P < 0.01) and the event rates of non-severe overall (RR 0.91, 95% CI 0.85-0.97, P < 0.01) and non-severe nocturnal hypoglycemia (RR 0.91, 95% CI 0.85-0.97, P < 0.01) were lower in the IDeg group. The incidences and event rates of both severe overall and nocturnal hypoglycemia were similar for the two groups (P > 0.05). The cost-effectiveness analysis showed that IGlar is the dominant treatment option compared with IDeg, with a lifetime savings of 1004 Chinese yuan in direct medical costs and a net gain of 0.015 QALYs per patient. Both one-way and probabilistic sensitivity analyses confirmed the robustness of the results. IGlar is a cost-saving option with incremental effectiveness compared with IDeg for the treatment of T2DM in China. Sanofi China.

876-P: Peer Support in Primary Care through the Shanghai Integration Model

Peer support (PS) is effective in promoting diabetes management, but needs pragmatic models for implementation. The Shanghai Integration Model links specialty/hospital care with primary care in Community Health Centers (CHCs), providing an organizational base for PS. This study reports formative evaluation, implementation and effectiveness of PS within the Shanghai model. The intervention emphasizes diet, physical activity, and insulin/medication use and addresses barriers to management and quality of life. Formative evaluation (3 focus groups, interviews with 15 CHC staff and patients, monthly consultation with CHC staff) led to emphases on group rather than individual PS with theme-based, interactive activities co-led with CHC staff. Peer leaders also follow-up with patients and organize neighborhood activities for physical activity, healthy diet, and comradery. In 9 CHCs, 74 volunteers trained as peer leaders reached 1284 adults (means: age = 68, years with diabetes = 11.8, HbA1c = 7.52%; % on insulin = 33.5%, oral medications = 76.2%). Counter to common difficulty reaching men, 43.1% are male. Two researchers familiar with each CHC rated implementation on 10 features (e.g., activities led by peer leaders) yielding low/medium/high PS implementation (3 CHCs each). Baseline to 12 months, levels of implementation differed on changes in HbA1c -- low: +0.07 points, medium: -0.17, high -0.18 (p &amp;lt; 0.001, controlling for initial HbA1c). For those with initial HbA1c &amp;gt; 8%, changes were more pronounced: -0.28, -1.01, and -0.86 points (p = 0.001, controlling initial HbA1c). Greater implementation was also associated with reductions in BMI (r = -.17) for those with baseline BMI over 26, and reductions in diabetes distress (r = -.20) and pain/negative emotion (r = -.14) among those elevated (top 33%) on these (ps ≤ 0.007). Peer support is feasible in CHCs. Extent of implementation is associated with improved glucose control, especially among those in poor control, as well as other clinical and quality-of-life indicators. Disclosure P.Y. Tang: None. Y. Liu: None. M.M. Coufal: None. Y. Qian: None. C. Cai: None. E.B. Fisher: Consultant; Self; Novo Nordisk Inc. Research Support; Self; Merck Foundation, Novo Nordisk Inc., Sanofi. W. Jia: None. Funding Merck &amp; Co., Inc. Foundation; Sanofi China; National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092926)

Identification of Chinese Hospitalized Patients' Risk Profile for Venous Thromboembolism (DissolVE1): A Study Protocol of a Non-Interventional Registry Study.

Venous thromboembolism (VTE) is a frequent cause of hospitalization, mortality, and long-term adverse consequence among medical and surgical inpatients. The current study is performed to identify the prophylaxis of patients with VTE risk within the 6weeks prior to the diagnosis of VTE, and the treatment pattern during 3months after VTE diagnosis in Chinese patients hospitalized for surgeries or medical illness. This multicenter, non-interventional, observational registry plans to enroll 1200 patients from 40 centers in China. The study will retrospectively collect data from patients' hospitalization record within 6weeks of VTE diagnosis and prospectively follow-up patients for 3months (in four visits). The primary outcome is to determine the percentage of patients receiving adequate prophylaxis in patients hospitalized within 6weeks before VTE diagnosis and treatment pattern within 3months after VTE diagnosis. Important secondary endpoints include determining patients with risk of VTE in the hospital setting, risk factors for VTE, and cost analysis of VTE treatment. The findings will determine the characteristics of VTE, its treatment practices, cost of treatment, and quality of life in patients; this information may help in building diagnostic and prophylaxis strategies for VTE in China. The study is registered in the Venous Thromboembolism Registry in China with study number DIREGL07581. Sanofi China.

A Cost-Effectiveness Analysis of Clopidogrel for Patients with Non-ST-Segment Elevation Acute Coronary Syndrome in China.

There are a number of economic evaluation studies of clopidogrel for patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) published from the perspective of multiple countries in recent years. However, relevant research is quite limited in China. We aimed to estimate the long-term cost effectiveness for up to 1-year treatment with clopidogrel plus acetylsalicylic acid (ASA) versus ASA alone for NSTEACS from the public payer perspective in China. This analysis used a Markov model to simulate a cohort of patients for quality-adjusted life years (QALYs) gained and incremental cost for lifetime horizon. Based on the primary event rates, adherence rate, and mortality derived from the CURE trial, hazard functions obtained from published literature were used to extrapolate the overall survival to lifetime horizon. Resource utilization, hospitalization, medication costs, and utility values were estimated from official reports, published literature, and analysis of the patient-level insurance data in China. To assess the impact of parameters' uncertainty on cost-effectiveness results, one-way sensitivity analyses were undertaken for key parameters, and probabilistic sensitivity analysis (PSA) was conducted using the Monte Carlo simulation. The therapy of clopidogrel plus ASA is a cost-effective option in comparison with ASA alone for the treatment of NSTEACS in China, leading to 0.0548life years (LYs) and 0.0518 QALYs gained per patient. From the public payer perspective in China, clopidogrel plus ASA is associated with an incremental cost of 43,340China Yuan (CNY) per QALY gained and 41,030CNY per LY gained (discounting at 3.5% per year). PSA results demonstrated that 88% of simulations were lower than the cost-effectiveness threshold of 150,721CYN per QALY gained. Based on the one-way sensitivity analysis, results are most sensitive to price of clopidogrel, but remain well below this threshold. This analysis suggests that treatment with clopidogrel plus ASA for up to 1 year for patients with NSTEACS is cost effective in the local context of China from a public payers' perspective. Sanofi China.