Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®)

Diabetes and Vascular Disease Research

Volumn 12, Issue 3, 2015, Pages 164-174

  Marx, Nikolaus ^a   Rosenstock, Julio ^b   Kahn, Steven E ^c   Zinman, Bernard ^d,e   Kastelein, John J ^f   Lachin, John M ^g   Espeland, Mark A ^h   Bluhmki, Erich ⁱ   Mattheus, Michaela ⁱ   Ryckaert, Bart ^j   Patel, Sanjay ^k   Johansen, Odd Erik ^l   Woerle, Hans Juergen ⁱ  

^a UNIVERSITY HOSPITAL RWTH AACHEN   (Germany)

^b UNIVERSITY OF TEXAS AT DALLAS   (United States)

^c UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^d MOUNT SINAI HOSPITAL   (Canada)

^e UNIVERSITY OF TORONTO   (Canada)

^f ACADEMIC MEDICAL CENTER   (Netherlands)

^g GEORGE WASHINGTON UNIVERSITY   (United States)

^h WAKE FOREST BAPTIST HEALTH   (United States)

ⁱ BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^j Boehringer Ingelheim   (Belgium)

^k BOEHRINGER INGELHEIM LTD   (United Kingdom)

^l Boehringer Ingelheim   (Norway)

more..

Author keywords

cardiovascular complications; dipeptidyl peptidase 4 inhibitor; macrovascular; sulphonylurea; Type 2 diabetes

Indexed keywords

GLIMEPIRIDE; HEMOGLOBIN A1C; LINAGLIPTIN; BIOLOGICAL MARKER; DIPEPTIDYL PEPTIDASE IV; DIPEPTIDYL PEPTIDASE IV INHIBITOR; DPP4 PROTEIN, HUMAN; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; INCRETIN; SULFONYLUREA DERIVATIVE;

ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DRUG EFFECT; FEMALE; FOLLOW UP; HEART INFARCTION; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; STUDY DESIGN; UNSTABLE ANGINA PECTORIS; ADULT; AGED; BLOOD; CARDIOVASCULAR DISEASES; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPARATIVE STUDY; DIABETES MELLITUS, TYPE 2; DOUBLE BLIND PROCEDURE; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; METABOLISM; METHODOLOGY; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATIENT SELECTION; RISK FACTOR; SAMPLE SIZE; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; BIOMARKERS; BLOOD GLUCOSE; CARDIOVASCULAR DISEASES; CLINICAL PROTOCOLS; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL PEPTIDASE 4; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DOUBLE-BLIND METHOD; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; INCRETINS; LINAGLIPTIN; MALE; MIDDLE AGED; PATIENT SELECTION; RESEARCH DESIGN; RISK FACTORS; SAMPLE SIZE; SULFONYLUREA COMPOUNDS; TREATMENT OUTCOME;

EID: 84926475145     PISSN: 14791641     EISSN: 17528984     Source Type: Journal    
DOI: 10.1177/1479164115570301     Document Type: Article

References (24)

1. Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011 ; 154: 602-613
2. Food and Drug Administration (Center for Drug Evaluation and Research). Guidance for industry: diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf (2008, accessed 18 October 2014).
3. Meinert CL, Knatterud GL, Prout TE, et al. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes. 1970 ; 19: 789-830
4. Ye Y, Perez-Polo JR, Aguilar D, et al. The potential effects of anti-diabetic medications on myocardial ischemia-reperfusion injury. Basic Res Cardiol. 2011 ; 106: 925-952
5. Rosenstock J, Marx N, Kahn SE, et al. Cardiovascular outcome trials in type 2 diabetes and the sulphonylurea controversy: rationale for the active-comparator CAROLINA® trial. Diabetes Vasc Dis Re. 2013 ; 10: 289-301
6. Hemmingsen B, Schroll JB, Lund SS, et al. Sulphonylurea monotherapy for patients with type 2 diabetes mellitus. Cochrane DB Syst Rev. 2013 ; 4 :
7. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 ; 35: 1364-1379
8. Deacon CF, Holst JJ. Linagliptin, a xanthine-based dipeptidyl peptidase-4 inhibitor with an unusual profile for the treatment of type 2 diabetes. Expert Opin Inv Drug. 2010 ; 19: 133-140
9. Blech S, Ludwig-Schwellinger E, Grafe-Mody EU, et al. The metabolism and disposition of the oral dipeptidyl peptidase-4 inhibitor, linagliptin, in humans. Drug Metab Dispos. 2010 ; 38: 667-678
10. Gallwitz B, Rosenstock J, Rauch T, et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 ; 380: 475-483
11. Grizzle JE. A note on stratifying versus complete random assignment in clinical trials. Control Clin Trials. 1982 ; 3: 365-368
12. Shannon RP.. DPP-4 inhibition and neuroprotection: do mechanisms matter?. Diabetes. 2013 ; 62: 1029-1031
13. Barbieri M, Rizzo MR, Marfella R, et al. Decreased carotid atherosclerotic process by control of daily acute glucose fluctuations in diabetic patients treated by DPP-IV inhibitors. Atherosclerosis. 2013 ; 227: 349-354
14. van Genugten RE, van Raalte DH, Diamant M. Dipeptidyl peptidase-4 inhibitors and preservation of pancreatic islet-cell function: a critical appraisal of the evidence. Diabetes Obes Metab. 2012 ; 14: 101-111
15. Johansen OE, Boehm BO, Grill V, et al. C-peptide levels in latent autoimmune diabetes in adults treated with linagliptin versus glimepiride: exploratory results from a two year double-blind, randomized, controlled study. Diabetes Care. 2014 ; 37: e11 - e12
16. Fadini GP, Avogaro A. Cardiovascular effects of DPP-4 inhibition: beyond GLP-1. Vasc Pharmacol. 2011 ; 55: 10-16
17. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. New Engl J Med. 2013 ; 369: 1317-1326
18. White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. New Engl J Med. 2013 ; 369: 1327-1335
19. Scirica BM, Braunwald E, Raz I, et al. Heart failure, saxagliptin and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 ;:
20. Nathan D, Buse JB, Kahn SE, et al. Rationale and design of the glycemia reduction approaches in diabetes: a comparative effectiveness study (GRADE). Diabetes Care. 2013 ; 36: 2254-2261
21. Goto A, Arah OA, Goto M, et al. Severe hypoglycaemia and cardiovascular disease: systematic review and meta-analysis with bias analysis. BMJ. 2013 ; 347: f4533
22. Zhang Y, Hong J, Chi J, et al. Head-to-head comparison of dipeptidyl peptidase-IV inhibitors and sulphonylureas - a meta-analysis from randomized clinical trials. Diabetes Metab Res. 2014 ; 30: 241-256
23. Avogaro A, Fadini GP. The effects of dipeptidyl peptidase-4 inhibition on microvascular diabetes complications. Diabetes Care. 2014 ; 37: 2884-2894
24. Tanaka T, Higashijima Y, Wada T, et al. The potential for renoprotection with incretin-based drugs. Kidney Int. 2014 ; 86: 701-711