Retrospective Study on the Effects of Glucose Abnormality on COVID-19 Outcomes in Japan.

INTRODUCTION: To investigate the effects of glucose abnormality on outcomes of hospitalized coronavirus disease 2019 (COVID-19) patients in Japan. METHODS: This study retrospectively analyzed 393 COVID-19 patients admitted at Juntendo University Hospital. Patients were divided into subgroups according to history of diabetes and blood glucose (BG) levels and subsequently compared in terms of in-hospital death, invasive ventilation, or a composite of both. RESULTS: Patients with glucose abnormality demonstrated more risk factors for serious COVID-19, such as high body mass index, dyslipidemia, and hypertension, and higher biomarkers for inflammation compared to those with normal BG levels. Oxygen inhalation and steroid use were more frequent among patients with than without glucose abnormality. Invasive ventilation was more frequent in patients with diabetes (9.5% vs. 3.2%, p = 0.033) and BG ≥ 140 mg/dl (11.0% vs. 3.1%, p = 0.009) compared with those without diabetes and BG < 140 mg/dl, respectively. Logistic regression analysis showed that BG ≥ 140 mg/dl was a risk factor for invasive ventilation [odds ratio (OR) 2.87, 95% CI 1.04-7.68, p = 0.037] or the composite outcome (OR 3.03, 95% CI 1.21-7.38, p = 0.015) even after adjusting for by age and gender. Kaplan-Meier analysis showed that glucose abnormality was significantly associated with invasive ventilation and that BG ≥ 140 mg/dl was a risk factor for invasive ventilation [hazard ratio (HR) 2.68, 95% CI 1.05-6.82, p = 0.039] and the composite of death and invasive ventilation (HR 2.77, 95% CI 1.21-6.37, p = 0.016) regardless of age and gender. CONCLUSIONS: Glucose abnormality, particularly BG ≥ 140 mg/dl, was associated with serious outcomes among Japanese COVID-19 patients, suggesting the need to consider high BG as a major risk factor for poor clinical course also in Japan.

HbA1c <7.0% 6 Months after Initiation of Second-Line Therapy in Patients with Uncontrolled Type 2 Diabetes Is Associated with Good Glycemic Control at 3 Years: The DISCOVER Study

Background: DISCOVER is a 3-year, observational study of people with type 2 diabetes (T2D) initiating a second-line glucose-lowering therapy in 38 countries. We assessed glycemic control after 3 years in participants with HbA1c ≥ 9.0% at baseline. Methods: Factors associated with an increased likelihood of having HbA1c < 7.0% after 3 years were assessed using a hierarchical logistic regression model. Results: Of 14 691 DISCOVER participants from 37 countries, 2233 (15.2%) had sufficient HbA1c data and HbA1c ≥ 9.0% at baseline. The majority of participants were men (58.0%), and the mean age was 54.4 years (SD: 11.2 years). The mean HbA1c at baseline was 10.4% (SD: 1.4%). After 3 years, 626 participants (28.0%) had HbA1c < 7.0% and 438 (19.6%) had HbA1c ≥ 9.0%. Time since T2D diagnosis ≥ 10 years (vs.< 5 years) was associated with a decreased likelihood of having HbA1c < 7.0% at 3 years (Figure). Second-line therapy with two or more glucose-lowering drugs (vs. insulin) and having HbA1c < 7.0% at 6 months (24.2% of patients) were associated with an increased likelihood of having HbA1c < 7.0% at 3 years. Conclusions: Less than a third of participants with HbA1c ≥ 9.0% at initiation of second-line therapy reached HbA1c < 7.0% after 3 years. Early glycemic control (HbA1c < 7.0% at 6 months) was a key factor associated with attaining this target. Disclosure: F. Bonnet: Consultant;Self;Amgen, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. H. Chen: None. A. Cooper: Employee;Self;AstraZeneca. M.B. Gomes: None. L. Ji: None. P. Leigh: Employee;Self;AstraZeneca. Employee;Spouse/Partner;Merck Sharp & Dohme Corp. L. Ramirez Gutierrez: None. M.V. Shestakova: None. I. Shimomura: Advisory Panel;Self;AstraZeneca K.K., Daiichi Sankyo, Novo Nordisk Pharma Ltd., Taisho Pharmaceutical Co., Ltd. Consultant;Self;MSD K.K., Novo Nordisk Pharma Ltd. Research Support;Self;Astellas Pharma Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited. Speaker's Bureau;Self;Amgen Astellas BioPharma K.K., Astellas Pharma Inc., AstraZeneca K.K., Covidien Japan Inc., Daiichi Sankyo, Eli Lilly Japan K.K., KOBAYASHI Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Nippon Chemiphar Co., Ltd., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Rohto Pharmaceutical Co., Ltd., Sanofi K.K., Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited. A. Siddiqui: None. F. Tang: Research Support;Self;AstraZeneca. J. Vora: Other Relationship;Self;AstraZeneca. H. Watada: Advisory Panel;Self;Abbott, Ajinomoto, Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Fuji Film, Janssen Pharmaceuticals, Inc., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. Research Support;Self;Astellas Pharma Inc., Bayer Yakuhin, Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited, Yakult. Speaker's Bureau;Self;stellas Pharma Inc., AstraZeneca, Bayer Yakuhin, Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. K. Khunti: Advisory Panel;Self;Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Board Member;Self;AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Consultant;Self;Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Research Support;Self;AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Servier. Speaker's Bureau;Self;Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Funding: AstraZeneca [ABSTRACT FROM AUTHOR] Copyright of Diabetes is the property of American Diabetes Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Effect of Tofogliflozin on Carotid Intima-Media Thickness in Patients with Type 2 Diabetes: Results from the Prospective, Randomized, Open-Label, Parallel-Group Comparative UTOPIA Trial

Background: This study aimed to investigate the preventive effects of tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT). Methods: This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study included 340 subjects with T2DM but no history of apparent CVD recruited at 24 clinical units. Subjects were randomly allocated to either the tofogliflozin treatment group (n=169) or conventional treatment group using drugs other than SGLT2 inhibitors (n=171). Primary outcomes were changes in mean and maximum common carotid IMT measured by echography during a 104-week treatment period. Findings: Although the mean IMT of the common carotid artery (mean-IMT-CCA), along with the right and left maximum IMT of the CCA (max-IMT-CCA), statistically significantly declined in both the tofogliflozin (-0.132 mm, SE 0.007;-0.163 mm, SE 0.013;-0.170 mm, SE 0.020;respectively) and the control group (-0·140 mm, SE 0·006;-0·190 mm, SE 0·012;-0·190 mm, SE 0·020;respectively), no significant difference was observed between the two groups. Relative to the control treatment effects, tofogliflozin statistically significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and statistically significantly increased the HDL-C. Interpretation: A tofogliflozin treatment regimen of 104 weeks was not associated with improved inhibition of carotid wall thickening in T2DM patients without apparent CVD, as compared to the effect of the control treatment. Disclosure: N. Katakami: Research Support;Self;Merck Sharp & Dohme Corp. Other Relationship;Self;Astellas Pharma Inc., AstraZeneca K.K., Daiichi Sankyo, Eli Lilly Japan K.K., Kowa Company, Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Shionogi & Co., Ltd., Takeda Pharmaceutical Company Limited. T. Mita: Research Support;Self;Boehringer Ingelheim Pharmaceuticals, Inc., Kowa Company, Ltd., Merck & Co., Inc., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. Speaker's Bureau;Self;Kowa Company, Ltd., Merck & Co., Inc., Mitsubishi Tanabe Pharma Corporation, Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. H. Watada: Advisory Panel;Self;Abbott, Ajinomoto, Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Fuji Film, Janssen Pharmaceuticals, Inc., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. Research Support;Self;Astellas Pharma Inc., Bayer Yakuhin, Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited, Yakult. Speaker's Bureau;Self;Astellas Pharma Inc., AstraZeneca, Bayer Yakuhin, Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. I. Shimomura: Advisory Panel;Self;AstraZeneca K.K., Daiichi Sankyo, Novo Nordisk Pharma Ltd., Taisho Pharmaceutical Co., Ltd. Consultant;Self;MSD K.K., Novo Nordisk Pharma Ltd. Research Support;Self;Astellas Pharma Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited. Speaker's Bureau;Self;Amgen Astellas BioPharma K.K., Astellas Pharma Inc., AstraZeneca K.K., Covidien Japan Inc., Daiichi Sankyo, Eli Lilly Japan K.K., KOBAYASHI Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Nippon Chemiphar Co., Ltd., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Rohto Pharmaceutical Co., Ltd., Sanofi K.K., Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited. [ABSTRACT FROM AUTHOR] Copyright of Diabetes is the property of American Diabetes Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Quality of Life in People with Type 2 Diabetes following Initiation of Second-Line Therapy: DISCOVER

Background: Symptom relief, prolonging survival and avoiding complications are key goals in treating type 2 diabetes (T2D), but health-related quality of life (HRQoL) may be as or more important to patients. We used DISCOVER, a global observational study of people with T2D initiating a second-line glucose-lowering therapy, to examine factors associated with HRQoL over 3 years of follow-up. Methods: HRQoL was assessed using the 36-item Short-Form Health Survey (SF-36) v2 mental and physical component summary (MCS;PCS) scores (higher scores = better HRQoL) and the Hypoglycemia Fear Survey II (HFS-II;higher scores = greater fear). Factors associated with HRQoL over time were assessed using longitudinal multivariable regression models. Results: Of 14 691 DISCOVER patients from 37 countries, baseline and ≥ 1 follow-up MCS, PCS and HFS-II scores were available for 7880, 7854 and 5387 patients, respectively. Over time, SF-36 scores decreased (change per 6 months from baseline: MCS −0.04 [95% CI: −0.05 to −0.04];PCS −0.03 [95% CI: −0.03 to −0.02]), and HFS-II scores increased (change: 0.10 [95% CI: 0.09 to 0.12]). Many factors were associated with HRQoL (Table). Conclusions: HRQoL worsened during follow-up. Patient-, disease- and treatment-related factors were associated with HRQoL differences. Assessing factors associated with HRQoL over time may inform interventions to improve this important outcome. Disclosure: A. Nicolucci: Consultant;Self;AstraZeneca. H. Chen: None. A. Cooper: Employee;Self;AstraZeneca. M.B. Gomes: None. L. Ji: None. K. Khunti: Advisory Panel;Self;Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Board Member;Self;AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Consultant;Self;Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Research Support;Self;AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Servier. Speaker's Bureau;Self;Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. M.N. Kosiborod: Consultant;Self;Amarin Corporation, Amgen, Applied Therapeutics, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Intarcia Therapeutics, Janssen Scientific Affairs, LLC., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi US, Vifor Pharma Group. Research Support;Self;AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. P. Leigh: Employee;Self;AstraZeneca. Employee;Spouse/Partner;Merck Sharp & Dohme Corp. L. Ramirez: None. M.V. Shestakova: None. I. Shimomura: Advisory Panel;Self;AstraZeneca K.K., Daiichi Sankyo, Novo Nordisk Pharma Ltd., Taisho Pharmaceutical Co., Ltd. Consultant;Self;MSD K.K., Novo Nordisk Pharma Ltd. Research Support;Self;Astellas Pharma Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited. Speaker's Bureau;Self;Amgen Astellas BioPharma K.K., Astellas Pharma Inc., AstraZeneca K.K., Covidien Japan Inc., Daiichi Sankyo, Eli Lilly Japan K.K., KOBAYASHI Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Mitsubishi T nabe Pharma Corporation, MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Nippon Chemiphar Co., Ltd., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Rohto Pharmaceutical Co., Ltd., Sanofi K.K., Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited. A. Siddiqui: None. F. Tang: Research Support;Self;AstraZeneca. J. Vora: Other Relationship;Self;AstraZeneca. H. Watada: Advisory Panel;Self;Abbott, Ajinomoto, Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Fuji Film, Janssen Pharmaceuticals, Inc., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. Research Support;Self;Astellas Pharma Inc., Bayer Yakuhin, Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited, Yakult. Speaker's Bureau;Self;Astellas Pharma Inc., AstraZeneca, Bayer Yakuhin, Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi-Aventis, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. S.V. Arnold: None. Funding: AstraZeneca [ABSTRACT FROM AUTHOR] Copyright of Diabetes is the property of American Diabetes Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)