Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) – DEVOTE 1

American Heart Journal

Volumn 179, Issue , 2016, Pages 175-183

  Marso, Steven P ^a   McGuire, Darren K ^a   Zinman, Bernard ^b   Poulter, Neil R ^c   Emerson, Scott S ^d   Pieber, Thomas R ^e   Pratley, Richard E ^f   Haahr, Poul Martin ^g   Lange, Martin ^g   Frandsen, Kirstine Brown ^g   Rabøl, Rasmus ^g   Buse, John B ^h  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b MOUNT SINAI HOSPITAL   (Canada)

^c IMPERIAL COLLEGE LONDON   (United Kingdom)

^d UNIVERSITY OF WASHINGTON   (United States)

^e MEDICAL UNIVERSITY OF GRAZ   (Austria)

^f FLORIDA HOSPITAL   (United States)

^g NOVO NORDISK A S   (Denmark)

^h UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN DEGLUDEC; INSULIN GLARGINE; PIG INSULIN; ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; LONG ACTING INSULIN;

ACUTE CORONARY SYNDROME; AGED; ARTICLE; BODY MASS; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CONTROLLED CLINICAL TRIAL (TOPIC); DRUG SAFETY; ELECTROCARDIOGRAM; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEALTH CARE QUALITY; HEART INFARCTION; HEMOGLOBIN BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SAFETY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SILENT MYOCARDIAL INFARCTION; STUDY DESIGN; ANGINA, UNSTABLE; CARDIOVASCULAR DISEASE; CHEMICALLY INDUCED; CLINICAL TRIAL; COMORBIDITY; COMPARATIVE STUDY; CONTROLLED STUDY; CORONARY DISEASE; DIABETES MELLITUS, TYPE 2; DOUBLE BLIND PROCEDURE; HEART FAILURE; HOSPITALIZATION; HYPOGLYCEMIA; METABOLISM; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; MYOCARDIAL INFARCTION; PHASE 3 CLINICAL TRIAL; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; RENAL INSUFFICIENCY, CHRONIC; RISK FACTOR; STATISTICS AND NUMERICAL DATA; STROKE;

AGED; ANGINA, UNSTABLE; CARDIOVASCULAR DISEASES; COMORBIDITY; CORONARY DISEASE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; HEART FAILURE; HEMOGLOBIN A, GLYCOSYLATED; HOSPITALIZATION; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN GLARGINE; INSULIN, LONG-ACTING; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PROPORTIONAL HAZARDS MODELS; RENAL INSUFFICIENCY, CHRONIC; RISK FACTORS; STROKE;

EID: 84979555894     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2016.06.004     Document Type: Article

References (19)

1. [1] Inzucchi, S.E., Bergenstal, R.M., Buse, J.B., et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 38 (2015), 140–149.
2. [2] FDA Briefing Document, Insulin degludec and insulin degludec/insulin aspart treatment to improve glycemic control in patients with diabetes mellitus briefing document. 2012 [Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327017.pdf; last accessed 31 March 2016].
3. [3] World Medical Association, Declaration of Helsinki. Ethical principles for medical research involving human subjects. J Indian Med Assoc 107 (2009), 403–405.
4. [4] ICH Harmonised Tripartite Guideline: guideline for good clinical practice. J Postgrad Med 47 (2001), 199–203.
5. [5] Levey, A.S., Stevens, L.A., Schmid, C.H., et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 150 (2009), 604–612.
6. [6] Seaquist, E.R., Anderson, J., Childs, B., et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 36 (2013), 1384–1395.
7. [7] Federation, I.D., IDF diabetes atlas. 7th ed., 2015, International Diabetes Federation, Brussels, Belgium [Available at: http://www.diabetesatlas.org/resources/2015-atlas.html; last accessed 31 March 2016].
8. [8] Mozaffarian, D., Benjamin, E.J., Go, A.S., et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation 131 (2015), e29–e322.
9. [9] Jonassen, I., Havelund, S., Hoeg-Jensen, T., et al. Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res 29 (2012), 2104–2114.
10. [10] Heise, T., Hermanski, L., Nosek, L., et al. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab 14 (2012), 859–864.
11. [11] Haahr, H., Heise, T., A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 53 (2014), 787–800.
12. [12] Vora, J., Cariou, B., Evans, M., et al. Clinical use of insulin degludec. Diabetes Res Clin Pract 109 (2015), 19–31.
13. [13] Heller, S., Buse, J., Fisher, M., et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 379 (2012), 1489–1497.
14. [14] Garber, A.J., King, A.B., Del Prato, S., et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 379 (2012), 1498–1507.
15. [15] Meneghini, L., Atkin, S.L., Gough, S.C., et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care 36 (2013), 858–864.
16. [16] Zinman, B., Philis-Tsimikas, A., Cariou, B., et al. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care 35 (2012), 2464–2471.
17. [17] Gough, S.C., Bhargava, A., Jain, R., et al. Low-volume insulin degludec 200 units/ml once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care 36 (2013), 2536–2542.
18. [18] Philis-Tsimikas, A., Del Prato, S., Satman, I., et al. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab 15 (2013), 760–766.
19. [19] ORIGIN Trial Investigators, Gerstein, H.C., Bosch, J., et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 367 (2012), 319–328.