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Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2."},{"pmid":"30900349","type":"BACKGROUND","citation":"Hinton W, Feher M, Munro N, Walker M, de Lusignan S. Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network. Diabetes Obes Metab. 2019 Jul;21(7):1661-1667. doi: 10.1111/dom.13710. Epub 2019 Apr 11."},{"pmid":"27295427","type":"RESULT","citation":"Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13."},{"pmid":"26855018","type":"RESULT","citation":"Petrie JR, Marso SP, Bain SC, Franek E, Jacob S, Masmiquel L, Leiter LA, Haluzik M, Satman I, Omar M, Shestakova M, Van Gaal L, Mann JF, Baeres FM, Zinman B, Poulter NR; LEADER investigators. LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial. J Hypertens. 2016 Jun;34(6):1140-50. doi: 10.1097/HJH.0000000000000890."},{"pmid":"26864124","type":"RESULT","citation":"Masmiquel L, Leiter LA, Vidal J, Bain S, Petrie J, Franek E, Raz I, Comlekci A, Jacob S, van Gaal L, Baeres FM, Marso SP, Eriksson M; LEADER investigators. LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial. Cardiovasc Diabetol. 2016 Feb 10;15:29. doi: 10.1186/s12933-016-0341-5."},{"pmid":"27320184","type":"RESULT","citation":"Satman I, R Rea R, Eriksson M, Mosenzon O, Pratley R, M Baeres F, D Orsted D, F Mann J; LEADER Trial Investigators. LEADER-6: Baseline renal function and associated factors in a high cardiovascular risk type 2 diabetes population. J Diabetes Complications. 2016 Nov-Dec;30(8):1631-1639. doi: 10.1016/j.jdiacomp.2016.06.001. Epub 2016 Jun 3."},{"pmid":"27274772","type":"RESULT","citation":"Rutten GE, Tack CJ, Pieber TR, Comlekci A, Orsted DD, Baeres FM, Marso SP, Buse JB; LEADER Investigators. LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ. Diabetol Metab Syndr. 2016 Jun 2;8:37. doi: 10.1186/s13098-016-0153-5. eCollection 2016."},{"pmid":"24176437","type":"RESULT","citation":"Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2."},{"pmid":"25275271","type":"RESULT","citation":"Steinberg WM, Nauck MA, Zinman B, Daniels GH, Bergenstal RM, Mann JF, Steen Ravn L, Moses AC, Stockner M, Baeres FM, Marso SP, Buse JB; LEADER Trial investigators. LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial. Pancreas. 2014 Nov;43(8):1223-31. doi: 10.1097/MPA.0000000000000229."},{"pmid":"25656058","type":"RESULT","citation":"Daniels GH, Hegedus L, Marso SP, Nauck MA, Zinman B, Bergenstal RM, Mann JF, Derving Karsbol J, Moses AC, Buse JB, Tuttle RM; LEADER Trial Investigators. LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations. Diabetes Obes Metab. 2015 May;17(5):477-86. doi: 10.1111/dom.12444. Epub 2015 Feb 23."},{"pmid":"28476871","type":"RESULT","citation":"Steinberg WM, Buse JB, Ghorbani MLM, Orsted DD, Nauck MA; LEADER Steering Committee; LEADER Trial Investigators. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial. Diabetes Care. 2017 Jul;40(7):966-972. doi: 10.2337/dc16-2747. Epub 2017 May 5."},{"pmid":"28854085","type":"RESULT","citation":"Mann JFE, Orsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornoe K, Zinman B, Buse JB; LEADER Steering Committee and Investigators. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Aug 31;377(9):839-848. doi: 10.1056/NEJMoa1616011."},{"pmid":"29279300","type":"RESULT","citation":"Hegedus L, Sherman SI, Tuttle RM, von Scholten BJ, Rasmussen S, Karsbol JD, Daniels GH; LEADER Publication Committee on behalf of the LEADER Trial Investigators. No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in Response to Liraglutide for Up to 5 Years in the LEADER Trial. Diabetes Care. 2018 Mar;41(3):620-622. doi: 10.2337/dc17-1956. Epub 2017 Dec 26."},{"pmid":"29627109","type":"RESULT","citation":"Marso SP, Nauck MA, Monk Fries T, Rasmussen S, Treppendahl MB, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Myocardial Infarction Subtypes in Patients With Type 2 Diabetes Mellitus and the Effect of Liraglutide Therapy (from the LEADER Trial). Am J Cardiol. 2018 Jun 15;121(12):1467-1470. doi: 10.1016/j.amjcard.2018.02.030. Epub 2018 Mar 15."},{"pmid":"29760228","type":"RESULT","citation":"Verma S, Bhatt DL, Bain SC, Buse JB, Mann JFE, Marso SP, Nauck MA, Poulter NR, Pratley RE, Zinman B, Michelsen MM, Monk Fries T, Rasmussen S, Leiter LA; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Polyvascular Disease: Results of the LEADER Trial. Circulation. 2018 May 15;137(20):2179-2183. doi: 10.1161/CIRCULATIONAHA.118.033898. No abstract available."},{"pmid":"29898902","type":"RESULT","citation":"Nauck MA, Jensen TJ, Rosenkilde C, Calanna S, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial. Diabetes Care. 2018 Aug;41(8):1663-1671. doi: 10.2337/dc17-1825. Epub 2018 Jun 13."},{"pmid":"29903847","type":"RESULT","citation":"Zinman B, Marso SP, Christiansen E, Calanna S, Rasmussen S, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Hypoglycemia, Cardiovascular Outcomes, and Death: The LEADER Experience. Diabetes Care. 2018 Aug;41(8):1783-1791. doi: 10.2337/dc17-2677. Epub 2018 Jun 14."},{"pmid":"29947247","type":"RESULT","citation":"Nauck MA, Tornoe K, Rasmussen S, Treppendahl MB, Marso SP; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Cardiovascular outcomes in patients who experienced a myocardial infarction while treated with liraglutide versus placebo in the LEADER trial. Diab Vasc Dis Res. 2018 Sep;15(5):465-468. doi: 10.1177/1479164118783935. Epub 2018 Jun 27."},{"pmid":"30072400","type":"RESULT","citation":"Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L, Kaltoft MS, Stellfeld M, Tornoe K, Pratley RE; LEADER Publication Committee on behalf of the LEADER Trial Investigators. The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial. Diabetes Care. 2018 Oct;41(10):2229-2235. doi: 10.2337/dc18-1094. Epub 2018 Aug 2."},{"pmid":"30354517","type":"RESULT","citation":"Verma S, Leiter LA, Mazer CD, Bain SC, Buse J, Marso S, Nauck M, Zinman B, Bosch-Traberg H, Rasmussen S, Michelsen MM, Bhatt DL. Liraglutide Reduces Cardiovascular Events and Mortality in Type 2 Diabetes Mellitus Independently of Baseline Low-Density Lipoprotein Cholesterol Levels and Statin Use. Circulation. 2018 Oct 9;138(15):1605-1607. doi: 10.1161/CIRCULATIONAHA.118.036862. No abstract available."},{"pmid":"30566006","type":"RESULT","citation":"Mann JFE, Fonseca V, Mosenzon O, Raz I, Goldman B, Idorn T, von Scholten BJ, Poulter NR. Effects of Liraglutide Versus Placebo on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease. Circulation. 2018 Dec 18;138(25):2908-2918. doi: 10.1161/CIRCULATIONAHA.118.036418."},{"pmid":"30566004","type":"RESULT","citation":"Verma S, Poulter NR, Bhatt DL, Bain SC, Buse JB, Leiter LA, Nauck MA, Pratley RE, Zinman B, Orsted DD, Monk Fries T, Rasmussen S, Marso SP. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus With or Without History of Myocardial Infarction or Stroke. Circulation. 2018 Dec 18;138(25):2884-2894. doi: 10.1161/CIRCULATIONAHA.118.034516."},{"pmid":"30260088","type":"RESULT","citation":"Nauck MA, Buse JB, Mann JFE, Pocock S, Bosch-Traberg H, Frimer-Larsen H, Ye Q, Gray A; LEADER Publication Committee for the LEADER Trial Investigators. Health-related quality of life in people with type 2 diabetes participating in the LEADER trial. Diabetes Obes Metab. 2019 Mar;21(3):525-532. doi: 10.1111/dom.13547. Epub 2018 Oct 25."},{"pmid":"30392095","type":"RESULT","citation":"Zinman B, Nauck MA, Bosch-Traberg H, Frimer-Larsen H, Orsted DD, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Liraglutide and Glycaemic Outcomes in the LEADER Trial. Diabetes Ther. 2018 Dec;9(6):2383-2392. doi: 10.1007/s13300-018-0524-z. Epub 2018 Nov 3."},{"pmid":"30508430","type":"RESULT","citation":"Gilbert MP, Bain SC, Franek E, Jodar-Gimeno E, Nauck MA, Pratley R, Rea RR, Kerr Saraiva JF, Rasmussen S, Tornoe K, von Scholten BJ, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled Trial. Ann Intern Med. 2019 Mar 19;170(6):423-426. doi: 10.7326/M18-1569. Epub 2018 Dec 4. No abstract available."},{"pmid":"41198855","type":"DERIVED","citation":"Heerspink HJL, Collier WH, Chaudhari J, Miao S, Tighiouart H, Appel GB, Caravaca-Fontan F, Floege J, Hannedouche T, Imai E, Jafar TH, Lewis JB, Li PKT, Locatelli F, Maes BD, Neuen BL, Perkovic V, Perrone RD, Remuzzi G, Schena FP, Wanner C, Greene T, Inker LA. A meta-analysis of albuminuria as a surrogate endpoint for kidney failure. Nat Med. 2026 Jan;32(1):281-287. doi: 10.1038/s41591-025-04057-z. Epub 2025 Nov 6."},{"pmid":"39963952","type":"DERIVED","citation":"Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2."},{"pmid":"35332654","type":"DERIVED","citation":"Verma S, Al-Omran M, Leiter LA, Mazer CD, Rasmussen S, Saevereid HA, Sejersten Ripa M, Bonaca MP. Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease. Diabetes Obes Metab. 2022 Jul;24(7):1288-1299. doi: 10.1111/dom.14700. Epub 2022 Apr 11."},{"pmid":"34704120","type":"DERIVED","citation":"Heller SR, Geybels MS, Iqbal A, Liu L, Wagner L, Chow E. A higher non-severe hypoglycaemia rate is associated with an increased risk of subsequent severe hypoglycaemia and major adverse cardiovascular events in individuals with type 2 diabetes in the LEADER study. Diabetologia. 2022 Jan;65(1):55-64. doi: 10.1007/s00125-021-05556-7. Epub 2021 Oct 26."},{"pmid":"33504496","type":"DERIVED","citation":"Persson F, Bain SC, Mosenzon O, Heerspink HJL, Mann JFE, Pratley R, Raz I, Idorn T, Rasmussen S, von Scholten BJ, Rossing P; LEADER Trial Investigators. Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial. Diabetes Care. 2021 Apr;44(4):1020-1026. doi: 10.2337/dc20-1622. Epub 2021 Jan 27."},{"pmid":"32744418","type":"DERIVED","citation":"Verma S, McGuire DK, Bain SC, Bhatt DL, Leiter LA, Mazer CD, Monk Fries T, Pratley RE, Rasmussen S, Vrazic H, Zinman B, Buse JB. Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Dec;22(12):2487-2492. doi: 10.1111/dom.14160. Epub 2020 Sep 4."},{"pmid":"32647053","type":"DERIVED","citation":"Crowley MJ, McGuire DK, Alexopoulos AS, Jensen TJ, Rasmussen S, Saevereid HA, Verma S, Buse JB. Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial. Diabetes Care. 2020 Sep;43(9):e108-e110. doi: 10.2337/dc20-0437. Epub 2020 Jul 9. No abstract available."},{"pmid":"32643857","type":"DERIVED","citation":"Verma S, Bain SC, Honore JB, F E Mann J, A Nauck M, E Pratley R, Rasmussen S, Sejersten Ripa M, Zinman B, Buse JB. Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2020 Nov;22(11):2193-2198. doi: 10.1111/dom.14140. Epub 2020 Aug 12."},{"pmid":"32372454","type":"DERIVED","citation":"Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3."},{"pmid":"32366578","type":"DERIVED","citation":"Buse JB, Bain SC, Mann JFE, Nauck MA, Nissen SE, Pocock S, Poulter NR, Pratley RE, Linder M, Monk Fries T, Orsted DD, Zinman B; LEADER Trial Investigators. Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial. Diabetes Care. 2020 Jul;43(7):1546-1552. doi: 10.2337/dc19-2251. Epub 2020 May 4."},{"pmid":"32164886","type":"DERIVED","citation":"Marso SP, Baeres FMM, Bain SC, Goldman B, Husain M, Nauck MA, Poulter NR, Pratley RE, Thomsen AB, Buse JB; LEADER Trial Investigators. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure. J Am Coll Cardiol. 2020 Mar 17;75(10):1128-1141. doi: 10.1016/j.jacc.2019.12.063."},{"pmid":"32132141","type":"DERIVED","citation":"Mann JFE, Fonseca VA, Poulter NR, Raz I, Idorn T, Rasmussen S, von Scholten BJ, Mosenzon O; LEADER Trial Investigators. Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease. Clin J Am Soc Nephrol. 2020 Apr 7;15(4):465-473. doi: 10.2215/CJN.11881019. Epub 2020 Mar 4."},{"pmid":"31959650","type":"DERIVED","citation":"Nauck MA, Kreiner E, Rasmussen S, Saevereid HA, Buse JB; LEADER Trial Investigators. Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920. Diabetes Care. 2020 Feb;43(2):e30-e31. doi: 10.2337/dci19-0067. No abstract available."},{"pmid":"31721979","type":"DERIVED","citation":"Verma S, Bain SC, Buse JB, Idorn T, Rasmussen S, Orsted DD, Nauck MA. Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2019 Dec 1;4(12):1214-1220. doi: 10.1001/jamacardio.2019.3080."},{"pmid":"31399438","type":"DERIVED","citation":"Nauck MA, Muus Ghorbani ML, Kreiner E, Saevereid HA, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care. 2019 Oct;42(10):1912-1920. doi: 10.2337/dc19-0415. Epub 2019 Aug 9."},{"pmid":"31282028","type":"DERIVED","citation":"Tack CJ, Jacob S, Desouza C, Bain SC, Buse JB, Nauck MA, Petrie JR, Poulter NR, Pratley RE, Stegmann HVBK, Bosch-Traberg H, Startseva E, Zinman B; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial. Diabetes Obes Metab. 2019 Nov;21(11):2450-2458. doi: 10.1111/dom.13826. Epub 2019 Jul 7."},{"pmid":"29693361","type":"DERIVED","citation":"Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"All subjects received placebo (0.6 mg/day) during the open labeled run-in period of 2-3 weeks and were instructed on how to administer the trial product. During this period the subjects demonstrated that they could adhere to the injection regimen in the trial.","recruitmentDetails":"410 sites in 32 countries across the 4 regions recruited subjects. Number of sites that recruited subjects is given in parenthesis. Europe (143), North America (135) (US, Canada) , Asia (33) (China, Taiwan, Korea, India) and Rest of the world (99) (Brazil, Mexico, Australia, South Africa, Turkey, Russian Federation, United Arab Emirates).","groups":[{"id":"FG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"FG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4668"},{"groupId":"FG001","numSubjects":"4672"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4529"},{"groupId":"FG001","numSubjects":"4513"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"139"},{"groupId":"FG001","numSubjects":"159"}]}],"dropWithdraws":[{"type":"Withdrawn - does not allow contact","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Alive","reasons":[{"groupId":"FG000","numSubjects":"127"},{"groupId":"FG001","numSubjects":"142"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All the randomised subjects.","groups":[{"id":"BG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"BG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4668"},{"groupId":"BG001","value":"4672"},{"groupId":"BG002","value":"9340"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"64.2","spread":"7.2"},{"groupId":"BG001","value":"64.4","spread":"7.2"},{"groupId":"BG002","value":"64.3","spread":"7.2"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Between 18 and 64 years","categories":[{"measurements":[{"groupId":"BG000","value":"2512"},{"groupId":"BG001","value":"2499"},{"groupId":"BG002","value":"5011"}]}]},{"title":"Between 65 to 84 years","categories":[{"measurements":[{"groupId":"BG000","value":"2139"},{"groupId":"BG001","value":"2148"},{"groupId":"BG002","value":"4287"}]}]},{"title":"85 years and over","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"42"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1657"},{"groupId":"BG001","value":"1680"},{"groupId":"BG002","value":"3337"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3011"},{"groupId":"BG001","value":"2992"},{"groupId":"BG002","value":"6003"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)","description":"Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.","populationDescription":"All randomised subjects.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"OG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4668"},{"groupId":"OG001","value":"4672"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.0"},{"groupId":"OG001","value":"14.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \\>=1.3 against Ha: HR \\<1.3 was less than 2.5% (or equivalent to 5% in two-sided test).","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \\>=1.3 against Ha: HR \\<1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed.","pValue":"<0.001","pValueComment":"p-value is reported for one-sided (α-level 0.025) test for non-inferiority (hazard ratio \\>=1.3).","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.868","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.778","ciUpperLimit":"0.968"},{"groupIds":["OG000","OG001"],"groupDescription":"If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR \\>=1.0 against Ha: HR \\<1.0 was less than 2.5% (or equivalent to 5% in two-sided test).","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","pValueComment":"p-value is reported for one-sided (α-level 0.025) test for superiority (hazard ratio\\>=1.0).","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.868","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.778","ciUpperLimit":"0.968"}]},{"type":"SECONDARY","title":"Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.","description":"Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.","populationDescription":"All randomised subjects.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"OG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4668"},{"groupId":"OG001","value":"4672"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.3"},{"groupId":"OG001","value":"22.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","statisticalComment":"The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.","paramType":"Hazard Ratio (HR)","paramValue":"0.881","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.807","ciUpperLimit":"0.962"}]},{"type":"SECONDARY","title":"Time From Randomisation to All Cause Death","description":"Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.","populationDescription":"All randomised subjects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"OG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4668"},{"groupId":"OG001","value":"4672"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.2"},{"groupId":"OG001","value":"9.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","statisticalComment":"The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.","paramType":"Hazard Ratio (HR)","paramValue":"0.847","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.739","ciUpperLimit":"0.971"}]},{"type":"SECONDARY","title":"Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome","description":"Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.","populationDescription":"All the randomised subjects.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"OG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4668"},{"groupId":"OG001","value":"4672"}]}],"classes":[{"title":"Cardiovascular death","categories":[{"measurements":[{"groupId":"OG000","value":"4.7"},{"groupId":"OG001","value":"6.0"}]}]},{"title":"Non-fatal stroke","categories":[{"measurements":[{"groupId":"OG000","value":"3.4"},{"groupId":"OG001","value":"3.8"}]}]},{"title":"Non-fatal myocardial infarction","categories":[{"measurements":[{"groupId":"OG000","value":"6.0"},{"groupId":"OG001","value":"6.8"}]}]},{"title":"Unstable angina pectoris (hospitalisation)","categories":[{"measurements":[{"groupId":"OG000","value":"2.6"},{"groupId":"OG001","value":"2.7"}]}]},{"title":"Coronary revascularisation","categories":[{"measurements":[{"groupId":"OG000","value":"8.7"},{"groupId":"OG001","value":"9.4"}]}]},{"title":"Heart failure (hospitalisation)","categories":[{"measurements":[{"groupId":"OG000","value":"4.7"},{"groupId":"OG001","value":"5.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.783","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.656","ciUpperLimit":"0.934"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.894","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.721","ciUpperLimit":"1.107"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.878","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.747","ciUpperLimit":"1.031"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.980","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.763","ciUpperLimit":"1.258"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.912","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.797","ciUpperLimit":"1.044"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.872","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.727","ciUpperLimit":"1.046"}]},{"type":"SECONDARY","title":"Time From Randomisation to First Occurrence of a Composite Microvascular Outcome","description":"Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following:\n\n* new onset of persistent macroalbuminuria\n* persistent doubling of serum creatinine\n* need for continuous renal replacement therapy\n* death due to renal disease\n* need for retinal photocoagulation or treatment with intravitreal agents\n* vitreous haemorrhage\n* diabetes-related blindness\n\nThe percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.","populationDescription":"All randomised subjects.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of subjects","timeFrame":"from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"OG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4668"},{"groupId":"OG001","value":"4672"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.6"},{"groupId":"OG001","value":"8.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.841","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.730","ciUpperLimit":"0.969"}]},{"type":"SECONDARY","title":"Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.","description":"Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.","populationDescription":"All randomised subjects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of subjects","timeFrame":"from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)","groups":[{"id":"OG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."},{"id":"OG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4668"},{"groupId":"OG001","value":"4672"}]}],"classes":[{"title":"Nephropathy composite","categories":[{"measurements":[{"groupId":"OG000","value":"5.7"},{"groupId":"OG001","value":"7.2"}]}]},{"title":"New onset of persistent macroalbuminuria","categories":[{"measurements":[{"groupId":"OG000","value":"3.4"},{"groupId":"OG001","value":"4.6"}]}]},{"title":"Persistent doubling of serum creatinine","categories":[{"measurements":[{"groupId":"OG000","value":"1.9"},{"groupId":"OG001","value":"2.1"}]}]},{"title":"Need for continuous renal-replacement therapy","categories":[{"measurements":[{"groupId":"OG000","value":"1.2"},{"groupId":"OG001","value":"1.4"}]}]},{"title":"Death due to renal disease","categories":[{"measurements":[{"groupId":"OG000","value":"0.2"},{"groupId":"OG001","value":"0.1"}]}]},{"title":"Retinopathy composite","categories":[{"measurements":[{"groupId":"OG000","value":"2.3"},{"groupId":"OG001","value":"2.0"}]}]},{"title":"Treatment with photocoagulation/intravitreal agent","categories":[{"measurements":[{"groupId":"OG000","value":"2.1"},{"groupId":"OG001","value":"1.8"}]}]},{"title":"Development of diabetes-related blindness","categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.02"}]}]},{"title":"Vitreous haemorrhage","categories":[{"measurements":[{"groupId":"OG000","value":"0.7"},{"groupId":"OG001","value":"0.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.782","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.666","ciUpperLimit":"0.918"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.738","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.602","ciUpperLimit":"0.905"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.890","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.667","ciUpperLimit":"1.189"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.869","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.607","ciUpperLimit":"1.244"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.593","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.521","ciUpperLimit":"4.869"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.149","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.869","ciUpperLimit":"1.519"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.159","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.869","ciUpperLimit":"1.546"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"0.335","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.004","ciUpperLimit":"30.847"},{"groupIds":["OG000","OG001"],"groupDescription":"Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor.","nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Cox","paramType":"Hazard Ratio (HR)","paramValue":"1.454","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.845","ciUpperLimit":"2.502"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).","description":"Safety was assessed using the full analysis set which included all randomised subjects.\n\nSerious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.","eventGroups":[{"id":"EG000","title":"Liraglutide","description":"Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.","seriousNumAffected":2320,"seriousNumAtRisk":4668,"otherNumAffected":684,"otherNumAtRisk":4668},{"id":"EG001","title":"Placebo","description":"Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.","seriousNumAffected":2354,"seriousNumAtRisk":4672,"otherNumAffected":210,"otherNumAtRisk":4672}],"seriousEvents":[{"term":"Abdominal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":4668},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":4672}]},{"term":"Abdominal discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":4668},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":4672}]},{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":4668},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":4672}]},{"term":"Abdominal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":4668},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":4672}]},{"term":"Abdominal incarcerated hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":4668},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":4672}]},{"term":"Abdominal mass","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":4668},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":4672}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":20,"numAffected":20,"numAtRisk":4668},{"groupId":"EG001","numEvents":16,"numAffected":15,"numAtRisk":4672}]},{"term":"Abdominal pain lower","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":4668},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":4672}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":5,"numAtRisk":4668},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":4672}]},{"term":"Abdominal panniculectomy","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":4668},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":4672}]},{"term":"Abdominal strangulated hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":4668},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":4672}]},{"term":"Abdominal wall abscess","organSystem":"Infections and 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