Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): A 26-week randomized, treat-to-target trial with a 26-week extension

Journal of Clinical Endocrinology and Metabolism

Volumn 98, Issue 3, 2013, Pages 1154-1162

  Mathieu, Chantal ^a,i   Hollander, Priscilla ^b   Miranda Palma, Bresta ^c   Cooper, John ^d   Franek, Edward ^e   Russell Jones, David ^f   Larsen, Jens ^g   Tamer, Søren Can ^g   Bain, Stephen C ^h  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b Baylor Endocrine Center   (United States)

^c UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^d STAVANGER UNIVERSITY HOSPITAL   (Norway)

^e MOSSAKOWSKI MEDICAL RESEARCH CENTRE   (Poland)

^f UNIVERSITY OF SURREY   (United Kingdom)

^g NOVO NORDISK A S   (Denmark)

^h SWANSEA UNIVERSITY   (United Kingdom)

ⁱ Division of Experimental Medicine and Endocrinology   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN DEGLUDEC; INSULIN GLARGINE;

ADULT; ARTICLE; CONTROLLED STUDY; DIET RESTRICTION; DISEASE SEVERITY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADULT; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 1; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN, LONG-ACTING; MALE; MIDDLE AGED; SELF ADMINISTRATION; TREATMENT OUTCOME;

EID: 84874858316     PISSN: 0021972X     EISSN: 19457197     Source Type: Journal    
DOI: 10.1210/jc.2012-3249     Document Type: Article

References (25)

1. Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care. 2010;33:240-245.
2. Rubin RR. 2005 Adherence to pharmacologic therapy in patients with type 2 diabetes mellitus. Am J Med 118(suppl 5A):27S-34S (Pubitemid 40585813)
3. Randløv J, Poulsen JU. How much do forgotten insulin injections matter to hemoglobin A1c in people with diabetes? A simulation study. J Diabetes Sci Techn. 2008;2:229-235.
4. Morris AD, Boyle DIR, McMahon AD, Greene SA, MacDonald TM, Newton RW; for the DARTS/MEMO Collaboration. 1997 Adherence to insulin treatment, glycemic control, and ketoacidosis in insulin-dependent diabetes mellitus. Lancet 350:1505-1510. (Pubitemid 28036554)
5. Anderson RT, Marrero D, Skovlund SE, Cramer J, Schwartz S. Selfreported compliance with insulin injection therapy in subjects with type 1 and type 2 diabetes. Diabetes Metab. 2003;29:A275 (Abstract).
6. Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012;29:682-689.
7. Jonassen I, Havelund S, Ribel U, et al. Insulin degludec is a new generation ultra-long acting basal insulin with a unique mechanism of protraction based on multi-hexamer formation. Diabetes 2010;59(suppl. 1):A11 (Abstract).
8. Heise T, Hövelmann U, Nosek L, Bøttcher S, Granhall C, Haahr H. Insulin degludec has a two-fold longer half-life and a more consistent pharmacokinetic profile than insulin glargine. Diabetes 2011;60(suppl 1A):LB11 (Abstract).
9. Heller S, Buse J, Fisher M, et al. Insulin degludec, an ultra-long acting 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 2012;379:1489-1497.
10. World Medical Association Inc. Declaration of Helsinki. Ethical principles for medical research involving human subjects. J Indian Med Assoc 2009;107:403-405.
11. ICH Harmonised Tripartite Guideline. Guideline for good clinical practice. J Postgrad Med. 2001;47:199-203.
12. Lantus. Lantus package insert. Bridgewater, NJ: Sanofi-Aventis; 2007.
13. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2011;34:S11-S61.
14. Lindholm A, Jensen LB, Home PD, Raskin P, Boehm B, Rastam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care. 2002;25: 876-882. (Pubitemid 41094286)
15. Mire-Sluis AR, Barrett YC, Devanarayan V, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004;289:1-16. (Pubitemid 38900899)
16. Food and Drug Administration. Guidance for Industry: diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. Draft Guideance 2008 Rockville, MD: US Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) [online]. Available from http://www.fda.gov/downloads/Drugs/Guidance Compliance Regulatory Information/Guidances/ucm071624.pdf. Accessed February 21, 2012.
17. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-986.
18. Heise, T, Hermanski, L, Nosek, L, Feldman A, Rasmussen S, Haahr H. The pharmacodynamic variability of insulin degludec is consistently lower than insulin glargine over 24 hours at steady state. Diabetes. 2011;60(suppl 1):A263 (Abstract).
19. Aschner P, Chan J, Owens DR, et al. Insulin glargine versus sitagliptin in insulin naïve patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet. 2012;379:2262-2269.
20. Meneghini LF, Traylor L, Schwartz SL. Improved glycemic control with insulin glargine versus pioglitazone as add-on therapy to sulphonylurea or metformin in patients with uncontrolled type 2 diabetes mellitus. Endocr Pract. 2010;16:588-599.
21. Diamant M, Van Gaal L, Stranks S, et al. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010;375:2234-2243.
22. Blonde L, Merilainen M, Karwe V, Raskin P, for the TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets-the TITRATETM study. Diabetes Obes Metab. 2009;11:623-631.
23. Bartley PC, Bogoevt M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to neutral protamine hagedorn insulin in patients with type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008;25:442-449. (Pubitemid 351490120)
24. Birkeland KI, Home PD, Wendisch U, et al. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultralong-acting insulin compared with insulin glargine. Diabetes Care. 2011;34:661-665.
25. Garber AJ, King AB, Del Prato S, et al. Insulin degludec, an ultralong acting 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. 2012;379:1498-1507.