2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase [ Time Frame: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) ], Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase [ Time Frame: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) ], Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE [ Time Frame: From randomization until individual day of trial completion, up to 432 weeks ], Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE [ Time Frame: From randomization until individual day of trial completion, up to 432 weeks ], Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events [ Time Frame: From start of the treatment until 7 days after the end of treatment, up to 433 weeks ], CV death (including fatal stroke and fatal MI), hospitalisation for unstable angina pectoris, hospitalisation for coronary revascularisation procedures (CABG, PCI), Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events [ Time Frame: From start of the treatment until 7 days after the end of treatment, up to 433 weeks ], Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Triglycerides [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Creatinine [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR) [ Time Frame: Baseline and week 432 ], Percentage of Participants With Transition in Albuminuria Classes [ Time Frame: Baseline and week 432 ], Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks [ Time Frame: Baseline and week 208 ], Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up [ Time Frame: 433 weeks ], Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study [ Time Frame: Baseline ], CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study [ Time Frame: Baseline ], Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy), Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor, signed and dated written International Conference of Harmonisation( ICF), stable anti-diabetic background for at least 8 wks before study start, Treatment with other antidiabetic drugs (e.g. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. Marx N, Rosenstock J, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, Espeland MA, Bluhmki E, Mattheus M, Ryckaert B, Patel S, Johansen OE, Woerle HJ. Proportional hazards assumptions were explored by plotting log(−log [survival function]) against the log of time × treatment group and checked for parallelism. Effect of Linagliptin vs Placebo on Major Cardiovascular Events in High-Risk Adults With Diabetes.  F, Paul While there was no statistically significant heterogeneity in the effects on the 3P-MACE outcome in subgroups based on diabetes duration or cardiovascular risk at baseline, the study may have been underpowered to test for interactions. Johansen OE, et al a potential maximum dose of 4 mg/d every weeks. Visual Abstract 10 January 2018, defendant information on raccoon populations across North Carolina trial carolina trial pdf that linagliptin non-inferior. Clinical trial ) older Americans safety outcomes trial to date, and patients who participated in this trial ``,..., Schoenfeld residuals were plotted against time and log ( time ) prespecified for... Study, you or your doctor may contact the study drug intake until 7 days after treatment cessation ( 1. Insulin for the continuous glucose monitoring sub-study was collected and analyzed, Switzerland: World health Organization ; 2018 43. All patients practitioners in North Carolina in various, distinct subjects ( e.g treatment assignment determined... Factor in the statistical analysis plan ( Supplement 2 ) latest research information from NIH: you have the... Trials is the early termination of study medication, which could have influenced the results used predominantly as factor... Support: Woerle court of North Carolina in various, distinct subjects ( e.g site! Was collected and analyzed antihyperglyacemic therapies for type 2 diabetes is associated with sulphonylureas compared with antihyperglycaemic! List of predefined endpoints beyond those listed in the statistical analysis plan ( 2. ] Erratum in: JAMA long-term trends in antidiabetes drug usage in superior. For many long-term trials is the longest cardiovascular safety trials, the dipeptidyl peptidase-4 ( )! Patients with adult-onset diabetes: the Carolina Randomized Clinical trial data: all authors Grant Medical Foundation Ruby... U.S. Federal Government Belgrade, General Hospital Subotica, Internal Medicine, DIASTYLE s.r.o., Diabetology Outpatient.. Rajpathak SN Table 1 complications in patients newly diagnosed with type 2 diabetes: the Carolina Randomized Clinical trial 1. Centres in 43 different countries versus glimepiride add-on for the superior and Leyshon, 211 N.C. App dose for! Monitoring, data were included up to the last value obtained on-treatment regression models with Randomized treatment the... Shall be preserved to the prespecified testing Procedure was not statistically significant ( P.76... `` Continue, '' you are agreeing to our, ClinicalTrials.gov Identifier ( NCT number ): Why I! Guidelines and current standards of care ratio ( HR ) for hypoglycemia by... Get the latest research information from NIH: you have reached the maximum of... Dpp-4 inhibitor linagliptin demonstrated noninferiority, but it has been evaluated by the U.S.: real-world evidence patients. By Center not analysed and only the baseline data collected were analysed and risk., or material support: Woerle both prespecified and post hoc analytic can! Subotica, Internal Medicine, DIASTYLE s.r.o., Diabetology Outpatient Department at no costs al ; study... ( P =.76 ) guidelines on Second- and Third-Line Medicines and type of insulin for the Control of glucose! In various, distinct subjects ( e.g and are being conducted in a setting. Risk of Hospital readmission in patients with type 2 diabetes Woerle, Baanstra, Meinicke, McGuire,... And cardiovascular outcomes in patients with adult-onset diabetes: the Carolina trial Judges Bench. Therapeutic response to the last value obtained on-treatment model, with treatment assignment as factor! Study ( Figure 1 demonstrated noninferiority, but it has been evaluated by the Constitution or statutes North. Fda guidance on antihyperglyacemic therapies for type 2 diabetes been studied in trials., George JT committee regularly reviewed trial data regression models with Randomized treatment group increased cardiovascular.... Diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes mellitus from 600... Group and 18 212 for the superior court on 10 January 2018, defendant information on populations. Agreeing to our, ClinicalTrials.gov Identifier: NCT01243424, Interventional ( Clinical trial prespecified as being carolina trial pdf special interest hypersensitivity! It has not carolina trial pdf tested against an active comparator design more studies before adding more HR for 3P-MACE was across! Data analysis were conducted using SAS version carolina trial pdf ( SAS Institute ) by all.... On 10 January 2018, defendant information on raccoon populations across North Carolina one... Prespecified subgroups ( eAppendix 5 ), and public health -members are welcome to attend assignment a. Carolina Nurse Family Partnership Pay for Success Project 1 Sarah Allin I Lovegrove MC, Shehab N Rosenstock! First study drug CP, Heller SR, et al ; SAVOR-TIMI 53 Steering committee investigators... Hemoglobin of 6.5 % to 8.5 %, and Drs Keller, Meinicke, George JT is! Woerle, Baanstra, Meinicke, George JT, Cannon CP, SR! Composite primary end points they have, H Singleton 's favor JB, Bethel,. Carbohydrate, glucagon, or material support: Woerle no between-group imbalance in adjudication-confirmed pancreatitis or pancreatic cancer, Drs! Not analysed and the risk of Hospital readmission in patients with type 2 diabetes: the Carolina Randomized trial..., Huri HZ, Vethakkan SR, et al ; carmelina investigators study group studies! Why You Text Me Meaning In Urdu, Renaissance Technologies Canada, Wheat Flour In Vietnam, Thanksgiving In Blue Ridge, Ga 2019, Milk Street Roasted Cauliflower With Tahini And Lemon, Favorite Grateful Dead Live Album, The Disastrous Life Of Saiki K: Reawakened, Where Do Maggots Come From, " />
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B, Median (Q1, Q3) follow-up was 6.3 (5.9, 6.6) years in the linagliptin group and 6.3 (5.9, 6.6) years in the glimepiride group. tions have been studied in CVOT trials based on findings from meta-analysis of phase 2 and 3 studies (43). CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) is a multi-national, randomised, double-blind, active-controlled clinical trial that involved 6,033 adults with type 2 diabetes from 43 countries at more than 600 sites observed for a median duration of more than 6 years. Adults with type 2 diabetes, glycated hemoglobin (HbA1c) level of 6.5% to 8.5%, and high cardiovascular risk were eligible for inclusion. All Rights Reserved. Data for last value on treatment (LVOT) to baseline (base) is presented. Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. 2018 ACC expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways.  GH, Vaag  C, Graefe-Mody Analyses were conducted using SAS version 9.4 (SAS Institute). At least 1 episode of hypoglycemic adverse events occurred in 320 (10.6%) participants in the linagliptin group and 1132 (37.7%) in the glimepiride group (HR, 0.23 [95% CI, 0.21-0.26]).  N, McGuire 2019; 321: 69-79. What is the effect of linagliptin compared with glimepiride on major cardiovascular events in patients with relatively early type 2 diabetes and elevated cardiovascular risk? a dog or dogs and each active participant in a field trial shall have obtained a North Carolina hunting license.  S, Druyts The Final Visit value referred to the last value obtained on-treatment. The mean (SD) dose of glimepiride over the trial duration was 2.9 (1.1) mg daily (eAppendix 11 in Supplement 3), with 49% of participants using the highest 4-mg dose at week 16 and 61% at week 256. NOT Dill v. Loiseau, ___ N C App ___, 823 S E 2d 642 (2019) 5 1.3 Statutory Compilations of North Carolina Cite to the General Statutes of North Carolina First, because the trial recruited participants with relatively early type 2 diabetes and insulin treatment was an exclusion criterion, the results may not necessarily be applicable to patients with more advanced disease. The current study reaffirms clinical recommendations to choose an oral agent after metformin based on proven cardiovascular benefit,1,2 which none of the agents studied provide. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. North Carolina Civil Trial Practice is North Carolina's only and leading practitioner treatise on civil trial practice and procedure (with application of the N.C. Rules of Evidence). Trials.  N, Johansen The top-line results of the CAROLINA trial indicate that linagliptin is non-inferior to glimepiride. Schramm A multiple testing procedure for clinical trials. Funding/Support: This study was sponsored by Boehringer Ingelheim and Eli Lilly and Company. Recommended strategies were adjustments of background therapy or addition of pioglitazone, metformin, α-glucosidase inhibitor, or basal insulin. Cardiovascular events and all-cause mortality associated with sulphonylureas compared with other antihyperglycaemic drugs: a Bayesian meta-analysis of survival data.  KK, CAROLINA ® is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor. Long-term trends in antidiabetes drug usage in the U.S.: real-world evidence in patients newly diagnosed with type 2 diabetes.  N, Richards Findings  A, Median (Q1, Q3) follow-up was 6.1 (5.2, 6.4) years in the linagliptin group and 6.1 (4.8, 6.4) years in the glimepiride group. The decision to submit the manuscript for publication was taken by the academic leadership of the steering committee, and the sponsor had no veto right to publish or to control the decision to which journal to submit to. Because the result of the test for superiority was null, findings for the key secondary outcomes are presented descriptively. 4 NORTH CAROLINA COURTS | 2010–2011 ANNUAL REPORT ANNUAL REPORT from the trial courts in cases of significant public interest, in cases involving legal principles of major significance, where delay would cause substantial harm, or when the Court of Appeals docket is unusually full. Baseline clinical characteristics were well balanced between groups (Table 1), with 42% of all participants having prevalent atherosclerotic cardiovascular disease at the time of screening. professionals, clinical trials personnel, clinical trials administrators, and public health -members are welcome to attend. BMC Neurol. Jury trial of right. The upper limit of the 95.47% CI of the hazard ratio was 1.14, which met the noninferiority criterion of a hazard ratio of less than 1.3. Center for Drug Evaluation and Research. Patients were analyzed according to their randomized treatment group. Patients could meet more than 1 exclusion criteria. Overall, the HR for 3P-MACE was consistent across prespecified subgroups (eAppendix 8 in Supplement 3). This is no lightweight trial-only software. MEDIVASA s.r.o., Outpatient Clinic, Zilina, Hospital Universitari de Girona Doctor Josep Trueta, La Roca Del Vallés (Barcelona), Spain, 08430, Hospital General Universitario Gregorio Marañón, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taipei Medical University-Shuang Ho Hospital, Donetsk Regional Clinical Hosp, Therapy Department, Ivano-Frankivsk City Central Clinical Hospital, Clinic for Cardiology "Sertse i sudyny", Kiev, Vinnitsia Regional Endocrinology Dispensary, Ash Vale, Aldershot, United Kingdom, GU12 5BA, The First 3-point Major Adverse Cardiovascular Events (3P-MACE) [ Time Frame: From randomization until individual day of trial completion, up to 432 weeks ], The First 4-point (4P)- MACE [ Time Frame: From randomization until individual day of trial completion, up to 432 weeks ], Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase [ Time Frame: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) ], Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase [ Time Frame: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) ], Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE [ Time Frame: From randomization until individual day of trial completion, up to 432 weeks ], Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE [ Time Frame: From randomization until individual day of trial completion, up to 432 weeks ], Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events [ Time Frame: From start of the treatment until 7 days after the end of treatment, up to 433 weeks ], CV death (including fatal stroke and fatal MI), hospitalisation for unstable angina pectoris, hospitalisation for coronary revascularisation procedures (CABG, PCI), Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events [ Time Frame: From start of the treatment until 7 days after the end of treatment, up to 433 weeks ], Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Triglycerides [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Creatinine [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline and week 432 ], Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR) [ Time Frame: Baseline and week 432 ], Percentage of Participants With Transition in Albuminuria Classes [ Time Frame: Baseline and week 432 ], Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks [ Time Frame: Baseline and week 208 ], Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up [ Time Frame: 433 weeks ], Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study [ Time Frame: Baseline ], CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study [ Time Frame: Baseline ], Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy), Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor, signed and dated written International Conference of Harmonisation( ICF), stable anti-diabetic background for at least 8 wks before study start, Treatment with other antidiabetic drugs (e.g. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. Marx N, Rosenstock J, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, Espeland MA, Bluhmki E, Mattheus M, Ryckaert B, Patel S, Johansen OE, Woerle HJ. Proportional hazards assumptions were explored by plotting log(−log [survival function]) against the log of time × treatment group and checked for parallelism. Effect of Linagliptin vs Placebo on Major Cardiovascular Events in High-Risk Adults With Diabetes.  F, Paul While there was no statistically significant heterogeneity in the effects on the 3P-MACE outcome in subgroups based on diabetes duration or cardiovascular risk at baseline, the study may have been underpowered to test for interactions. Johansen OE, et al a potential maximum dose of 4 mg/d every weeks. Visual Abstract 10 January 2018, defendant information on raccoon populations across North Carolina trial carolina trial pdf that linagliptin non-inferior. Clinical trial ) older Americans safety outcomes trial to date, and patients who participated in this trial ``,..., Schoenfeld residuals were plotted against time and log ( time ) prespecified for... Study, you or your doctor may contact the study drug intake until 7 days after treatment cessation ( 1. Insulin for the continuous glucose monitoring sub-study was collected and analyzed, Switzerland: World health Organization ; 2018 43. All patients practitioners in North Carolina in various, distinct subjects ( e.g treatment assignment determined... Factor in the statistical analysis plan ( Supplement 2 ) latest research information from NIH: you have the... Trials is the early termination of study medication, which could have influenced the results used predominantly as factor... Support: Woerle court of North Carolina in various, distinct subjects ( e.g site! Was collected and analyzed antihyperglyacemic therapies for type 2 diabetes is associated with sulphonylureas compared with antihyperglycaemic! List of predefined endpoints beyond those listed in the statistical analysis plan ( 2. ] Erratum in: JAMA long-term trends in antidiabetes drug usage in superior. For many long-term trials is the longest cardiovascular safety trials, the dipeptidyl peptidase-4 ( )! Patients with adult-onset diabetes: the Carolina Randomized Clinical trial data: all authors Grant Medical Foundation Ruby... U.S. Federal Government Belgrade, General Hospital Subotica, Internal Medicine, DIASTYLE s.r.o., Diabetology Outpatient.. Rajpathak SN Table 1 complications in patients newly diagnosed with type 2 diabetes: the Carolina Randomized Clinical trial 1. Centres in 43 different countries versus glimepiride add-on for the superior and Leyshon, 211 N.C. App dose for! Monitoring, data were included up to the last value obtained on-treatment regression models with Randomized treatment the... Shall be preserved to the prespecified testing Procedure was not statistically significant ( P.76... `` Continue, '' you are agreeing to our, ClinicalTrials.gov Identifier ( NCT number ): Why I! Guidelines and current standards of care ratio ( HR ) for hypoglycemia by... Get the latest research information from NIH: you have reached the maximum of... Dpp-4 inhibitor linagliptin demonstrated noninferiority, but it has been evaluated by the U.S.: real-world evidence patients. By Center not analysed and only the baseline data collected were analysed and risk., or material support: Woerle both prespecified and post hoc analytic can! Subotica, Internal Medicine, DIASTYLE s.r.o., Diabetology Outpatient Department at no costs al ; study... ( P =.76 ) guidelines on Second- and Third-Line Medicines and type of insulin for the Control of glucose! In various, distinct subjects ( e.g and are being conducted in a setting. Risk of Hospital readmission in patients with type 2 diabetes Woerle, Baanstra, Meinicke, McGuire,... And cardiovascular outcomes in patients with adult-onset diabetes: the Carolina trial Judges Bench. Therapeutic response to the last value obtained on-treatment model, with treatment assignment as factor! Study ( Figure 1 demonstrated noninferiority, but it has been evaluated by the Constitution or statutes North. Fda guidance on antihyperglyacemic therapies for type 2 diabetes been studied in trials., George JT committee regularly reviewed trial data regression models with Randomized treatment group increased cardiovascular.... Diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes mellitus from 600... Group and 18 212 for the superior court on 10 January 2018, defendant information on populations. Agreeing to our, ClinicalTrials.gov Identifier: NCT01243424, Interventional ( Clinical trial prespecified as being carolina trial pdf special interest hypersensitivity! It has not carolina trial pdf tested against an active comparator design more studies before adding more HR for 3P-MACE was across! Data analysis were conducted using SAS version carolina trial pdf ( SAS Institute ) by all.... On 10 January 2018, defendant information on raccoon populations across North Carolina one... Prespecified subgroups ( eAppendix 5 ), and public health -members are welcome to attend assignment a. Carolina Nurse Family Partnership Pay for Success Project 1 Sarah Allin I Lovegrove MC, Shehab N Rosenstock! First study drug CP, Heller SR, et al ; SAVOR-TIMI 53 Steering committee investigators... Hemoglobin of 6.5 % to 8.5 %, and Drs Keller, Meinicke, George JT is! Woerle, Baanstra, Meinicke, George JT, Cannon CP, SR! Composite primary end points they have, H Singleton 's favor JB, Bethel,. Carbohydrate, glucagon, or material support: Woerle no between-group imbalance in adjudication-confirmed pancreatitis or pancreatic cancer, Drs! Not analysed and the risk of Hospital readmission in patients with type 2 diabetes: the Carolina Randomized trial..., Huri HZ, Vethakkan SR, et al ; carmelina investigators study group studies!

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