Endocrinology & Metabolism Clinical Trials

Statistical methods in endocrinology & metabolism trials

The methods these trials rely on most, based on the statistical analyses posted to ClinicalTrials.gov, with the tutorial that explains each one.

All endocrinology & metabolism trials

45 results

• AWARD-6Independent statistical analysis of the randomized phase 3 AWARD-6 trial comparing dulaglutide with liraglutide in type 2 diabetes, including the HbA1c non-inferiority analysis, secondary endpoints, statistical methods, safety, and interpretation.Phase 3Results postedn = 599NCT01624259
• BARI 2DIndependent statistical analysis of BARI 2D, a randomized phase 3 factorial trial comparing revascularization with medical therapy and insulin-sensitizing with insulin-providing glycemic strategies, including five-year all-cause mortality and death, myocardial infarction, or…Phase 3Results postedn = 2,368NCT00006305
• CANTATAComplete statistical analysis of the phase 3 CANTATA trial, including trial design, HbA1c efficacy, secondary metabolic endpoints, ANCOVA, logistic regression, confidence intervals, and statistical interpretation.Phase 3Results postedn = 344NCT01106690
• CARMELINAIndependent statistical analysis of CARMELINA (NCT01897532), a randomized phase 4 trial of linagliptin versus placebo in patients with type 2 diabetes mellitus, including time-to-event methodology, non-inferiority testing, cardiovascular and renal endpoints, safety,…Phase 4Results postedn = 6,991NCT01897532
• CAROLINAIndependent statistical analysis of the CAROLINA phase 3 trial comparing linagliptin with glimepiride in patients with type 2 diabetes, including non-inferiority testing, cardiovascular outcomes, glycaemic control, ANCOVA, Cox regression, and logistic regression.Phase 3Results postedn = 6,103NCT01243424
• CIRTComplete statistical analysis of CIRT (NCT01594333), a randomized phase 3 trial of methotrexate versus placebo in cardiovascular disease, including time-to-event endpoints, hazard ratios, confidence intervals, log-rank testing, stratification, multiplicity, safety, and statistical…Phase 3Results postedn = 4,786NCT01594333
• CREDENCEComplete statistical analysis of CREDENCE, the randomized phase 3 trial evaluating canagliflozin versus placebo for renal and cardiovascular outcomes in participants with type 2 diabetes and diabetic nephropathy.Phase 3Results postedn = 4,401NCT02065791
• EMPA-REG OUTCOMEComplete statistical analysis of EMPA-REG OUTCOME, the randomized phase 3 trial of empagliflozin in patients with type 2 diabetes mellitus, including its time-to-event endpoints, Cox proportional-hazards analyses, non-inferiority framework, cardiovascular outcomes, microvascular…Phase 3Results postedn = 7,064NCT01131676
• EXSCELA detailed independent statistical analysis of EXSCEL, the phase 3 trial of exenatide once weekly versus placebo in patients with type 2 diabetes mellitus, including its randomized design, time-to-event endpoints, Cox models,…Phase 3Results postedn = 14,752NCT01144338
• FIDELIO-DKDAn independent statistical analysis of FIDELIO-DKD, the randomized phase 3 trial of finerenone versus placebo in subjects with type 2 diabetes mellitus and diabetic kidney disease. Includes the primary renal composite, cardiovascular…Phase 3Results postedn = 5,734NCT02540993
• FIGARO-DKDIndependent statistical analysis of FIGARO-DKD, a randomized phase 3 trial of finerenone versus placebo in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease.Phase 3Results postedn = 7,352NCT02545049
• FLOWIndependent statistical analysis of the FLOW phase 3 trial of semaglutide versus placebo in people with type 2 diabetes and chronic kidney disease, including trial design, the composite renal endpoint, Cox proportional-hazards…Phase 3Results postedn = 3,533NCT03819153
• FOURIERIndependent statistical analysis of the FOURIER phase 3 trial of evolocumab versus placebo in subjects with elevated cardiovascular risk and dyslipidemia, including time-to-event endpoints, hazard ratios, stratified log-rank testing, multiplicity, and interpretation.Phase 3Results postedn = 27,564NCT01764633
• FREEDOMIndependent statistical analysis of the FREEDOM trial comparing coronary artery bypass grafting with percutaneous coronary intervention in individuals with diabetes and multivessel coronary artery disease, including time-to-event methods, reported results, safety, and…Phase 3Results postedn = 1,900NCT00086450
• LEADERComplete statistical analysis of the LEADER phase 3 trial of liraglutide versus placebo in type 2 diabetes, including trial design, cardiovascular time-to-event endpoints, Cox regression, non-inferiority and superiority testing, secondary outcomes, safety,…Phase 3Results postedn = 9,341NCT01179048
• ORIGINComplete statistical analysis of the ORIGIN phase 3 trial, including its factorial design, cardiovascular and diabetes endpoints, Cox and log-rank methods, odds ratios, confidence intervals, and statistical interpretation.Phase 3Results postedn = 12,537NCT00069784
• ORION-10Independent statistical analysis of ORION-10, a randomized phase 3 trial of inclisiran versus placebo in participants with atherosclerotic cardiovascular disease and elevated low-density lipoprotein cholesterol, including ANCOVA results, confidence intervals, p-values, trial…Phase 3Results postedn = 1,561NCT03399370
• ORION-11Complete statistical analysis of ORION-11, the randomized phase 3 trial of inclisiran in subjects with ASCVD or ASCVD-risk equivalents and elevated LDL-C, including ANCOVA methodology, primary and secondary endpoint results, confidence intervals,…Phase 3Results postedn = 1,617NCT03400800
• PIONEER 6Independent statistical analysis of PIONEER 6, the randomized phase 3 trial of oral semaglutide versus placebo in subjects with type 2 diabetes, including its MACE endpoint, non-inferiority analysis, Cox model, hazard ratio,…Phase 3Results postedn = 3,183NCT02692716
• REDUCE-ITComplete statistical analysis of REDUCE-IT (NCT01492361), a randomized phase 3 trial of AMR101 versus placebo in high-risk patients with cardiovascular disease and hypertriglyceridemia on statin therapy.Phase 3Results postedn = 8,179NCT01492361
• REWINDComplete statistical analysis of the REWIND phase 3 trial of dulaglutide versus placebo in type 2 diabetes and cardiovascular disease, including its randomized design, time-to-event endpoints, Cox proportional-hazards analysis, cardiovascular outcomes, and…Phase 3Results postedn = 9,901NCT01394952
• SCOREDIndependent statistical analysis of SCORED (NCT03315143), a randomized phase 3 trial of sotagliflozin versus placebo in participants with type 2 diabetes and moderate renal impairment at cardiovascular risk. Includes the primary cardiovascular…Phase 3Results postedn = 10,584NCT03315143
• SELECTAn independent statistical analysis of the SELECT phase 3 trial of semaglutide versus placebo in patients with overweight or obesity, including trial design, the primary time-to-event endpoint, Cox proportional-hazards analysis, and interpretation.Phase 3Results postedn = 17,604NCT03574597
• SOLOIST-WHFIndependent statistical analysis of SOLOIST-WHF (NCT03521934), evaluating sotagliflozin versus placebo in participants with type 2 diabetes and worsening heart failure. Includes trial design, registered endpoints, Cox, ANCOVA and MMRM methodology, reported results,…Phase 3Results postedn = 1,222NCT03521934
• SONARIndependent statistical analysis of the phase 3 SONAR trial of atrasentan versus placebo in diabetic nephropathy, including the composite renal endpoint, hazard ratios, confidence intervals, p-values, trial design, and statistical methodology.Phase 3Results postedn = 5,107NCT01858532
• STEP 1Complete statistical analysis of STEP 1 (NCT03548935), a randomized phase 3 trial of semaglutide 2.4 mg versus placebo in people with overweight or obesity, including its ANCOVA and logistic-regression analyses, effect estimates,…Phase 3Results postedn = 1,961NCT03548935
• STEP 2Complete statistical analysis of STEP 2, the randomized phase 3 trial of semaglutide in people with type 2 diabetes and overweight or obesity, including trial design, primary endpoints, ANCOVA, MMRM, logistic regression,…Phase 3Results postedn = 1,210NCT03552757
• STEP 3Complete statistical analysis of STEP 3 (NCT03611582), a phase 3 randomized trial evaluating semaglutide versus placebo for weight reduction in people with overweight or obesity, including endpoint definitions, ANCOVA, MMRM, logistic regression,…Phase 3Results postedn = 611NCT03611582
• STEP 4Independent statistical analysis of STEP 4 (NCT03548987), a randomized phase 3 trial evaluating change in body weight with semaglutide 2.4 mg versus placebo in people with overweight or obesity.Phase 3Results postedn = 902NCT03548987
• STEP 5Complete statistical analysis of the STEP 5 phase 3 trial of semaglutide versus placebo in adults with overweight or obesity, including trial design, primary endpoints, ANCOVA, MMRM, logistic regression, confidence intervals, and…Phase 3Results postedn = 304NCT03693430
• STEP 8Complete statistical analysis of STEP 8, a randomized phase 3 trial comparing semaglutide 2.4 mg with liraglutide 3.0 mg in people living with overweight or obesity, including the registered body-weight endpoint, ANCOVA…Phase 3Results postedn = 338NCT04074161
• STEP-HFpEFIndependent statistical analysis of the phase 3 STEP-HFpEF trial of semaglutide in people living with heart failure and obesity, including trial design, ANCOVA methodology, primary endpoints, confidence intervals, p-values, safety, and interpretation.Phase 3Results postedn = 529NCT04788511
• SURMOUNT-3Independent statistical analysis of the phase 3 SURMOUNT-3 trial of tirzepatide in participants with obesity or overweight after a lifestyle weight loss program, including trial design, primary endpoints, reported estimates, statistical methods,…Phase 3Results postedn = 579NCT04657016
• SURMOUNT-OSAIndependent statistical analysis of SURMOUNT-OSA, a randomized phase 3 trial of tirzepatide in participants with obstructive sleep apnea and obesity, including AHI results, ANCOVA, logistic regression, confidence intervals, and safety.Phase 3Results postedn = 469NCT05412004
• SURPASS-3Complete statistical analysis of SURPASS-3, a randomized phase 3 trial comparing tirzepatide with insulin degludec in participants with type 2 diabetes, including HbA1c, body weight, fasting serum glucose, treatment satisfaction, statistical methodology,…Phase 3Results postedn = 1,444NCT03882970
• SURPASS-4Independent statistical analysis of SURPASS-4, a randomized phase 3 trial of once-weekly tirzepatide versus once-daily insulin glargine in participants with type 2 diabetes and increased cardiovascular risk.Phase 3Results postedn = 2,002NCT03730662
• SURPASS-5Complete statistical analysis of SURPASS-5, a randomized phase 3 trial of tirzepatide versus placebo in participants with type 2 diabetes inadequately controlled on insulin glargine with or without metformin.Phase 3Results postedn = 475NCT04039503
• SUSTAIN-3Independent statistical analysis of SUSTAIN-3, the randomized phase 3 trial comparing once-weekly semaglutide 1.0 mg with exenatide ER 2.0 mg in subjects with type 2 diabetes receiving 1–2 oral antidiabetic drugs.Phase 3Results postedn = 813NCT01885208
• SUSTAIN-7Independent statistical analysis of the SUSTAIN-7 phase 3 trial comparing semaglutide with dulaglutide as add-on to metformin in subjects with type 2 diabetes, including mixed-effects modeling, non-inferiority and superiority testing, confidence intervals,…Phase 3Results postedn = 1,201NCT02648204
• SWITCH 1Independent statistical analysis of SWITCH 1 (NCT02034513), a randomized double-blind phase 3 crossover trial comparing insulin degludec with insulin glargine in type 1 diabetes, including its non-inferiority framework, Poisson regression, MMRM, McNemar…Phase 3Results postedn = 501NCT02034513
• SWITCH 2Independent statistical analysis of SWITCH 2, a randomized double-blind crossover phase 3 trial comparing insulin degludec with insulin glargine in subjects with type 2 diabetes, including hypoglycaemia, HbA1c, crossover design, non-inferiority, and…Phase 3Results postedn = 721NCT02030600
• TECOSComplete statistical analysis of TECOS, the randomized phase 3 study of sitagliptin versus placebo in type 2 diabetes mellitus, including non-inferiority analysis of MACE plus, Cox proportional-hazards methodology, secondary endpoints, safety, and…Phase 3Results postedn = 14,671NCT00790205
• THEMISIndependent statistical analysis of THEMIS, a randomized phase 3 trial of ticagrelor 60 mg versus placebo in patients with type 2 diabetes mellitus, including time-to-event methods, hazard ratios, confidence intervals, safety analyses,…Phase 3Results postedn = 19,271NCT01991795
• VADTIndependent statistical analysis of VADT (NCT00032487), evaluating intensive versus standard glycemic control in type 2 diabetes, with a focus on major macrovascular events, hazard ratios, log-rank testing, confidence intervals, and equivalence testing.Phase 3Results postedn = 1,791NCT00032487
• VESALIUS-CVComplete statistical analysis of VESALIUS-CV, evaluating evolocumab versus placebo in patients at high cardiovascular risk without prior myocardial infarction or stroke. Includes trial design, time-to-event endpoints, hazard ratios, confidence intervals, statistical methodology,…Phase 3Results postedn = 12,301NCT03872401

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