Insulin Degludec Versus Insulin Glargine in Type 1 and Type 2 Diabetes Mellitus: A Meta-Analysis of Endpoints in Phase 3a Trials

Diabetes Therapy

Volumn 5, Issue 2, 2014, Pages 435-446

  Vora, Jiten ^a   Christensen, Torsten ^b   Rana, Azhar ^b   Bain, Steve C ^c  

^a ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

^b NOVO NORDISK A S   (Denmark)

^c ABERTAWE BRO MORGANNWG UNIVERSITY HEALTH BOARD   (United Kingdom)

Author keywords

Fasting plasma glucose; Glycosylated hemoglobin (HbA1c); Hypoglycemia; Insulin degludec; Insulin dose; Insulin glargine; Type 1 diabetes mellitus; Type 2 diabetes mellitus

Indexed keywords

GLYCOSYLATED HEMOGLOBIN; INSULIN DEGLUDEC; INSULIN GLARGINE;

ARTICLE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; META ANALYSIS; NOCTURNAL HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL (TOPIC); QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC);

EID: 84918780207     PISSN: 18696953     EISSN: 18696961     Source Type: Journal    
DOI: 10.1007/s13300-014-0076-9     Document Type: Article

References (23)

1. Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of type I and type II diabetes. Diabetologia. 2002;45:937–48.
2. Graveling AJ, Frier BM. Hypoglycaemia: an overview. Prim Care Diabetes. 2009;3:131–9.
3. Leiter LA, Yale J-F, Chiasson J-L, Harris SB, Kleinstiver P, Sauriol L. Assessment of the impact of fear of hypoglycemic episodes on glycemic and hypoglycemic management. Can J Diabetes. 2005;29:186–92.
4. Horvath K, Jeitler K, Berghold A, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2007;(2):CD005613.
5. Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012;14:859–64.
6. Heise T, Nosek L, Bøttcher SG, Hastrup H, Haahr H. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab. 2012;14:944–50.
7. Jonassen I, Havelund S, Hoeg-Jensen T, Steensgaard DB, Wahlund PO, Ribel U. Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res. 2012;29:2104–14.
8. Kurtzhals P, Heise T, Strauss HM, et al. Multi-hexamer formation is the underlying mechanism behind the ultra-long glucose-lowering effect of insulin degludec. Diabetes. 2011;60(Suppl 1):LB12 (abstract 42-LB).
9. 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. 2012;379:1489–97.
10. Mathieu C, Hollander P, Miranda-Palma B, et al. 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. J Clin Endocrinol Metab. 2013;98:1154–62.
11. Garber AJ, King AB, 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. 2012;379:1498–507.
12. Gough SC, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. 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. 2013;36:2536–42.
13. Meneghini L, Atkin SL, Gough SC, 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 people with type 2 diabetes. Diabetes Care. 2013;36:858–64.
14. Onishi Y, Iwamoto Y, Yoo SJ, Clauson P, Tamer SC, Park S. Insulin degludec compared with insulin glargine in insulin-naïve patients with type 2 diabetes: a 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Invest. 2013;4:605–12.
15. 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. 2012;35:2464–71.
16. 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. 2013;15:760–6.
17. Ratner RE, Gough SC, Mathieu C, et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013;15:175–84.
18. Freemantle N, Evans M, Christensen T, Wolden ML, Bjorner JB. A comparison of health-related quality of life (health utility) between insulin degludec and insulin glargine: a meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013;15:564–71.
19. Freemantle N, Meneghini L, Christensen T, Wolden ML, Jendle J, Ratner R. Insulin degludec improves health-related quality of life (SF-36(R)) compared with insulin glargine in people with type 2 diabetes starting on basal insulin: a meta-analysis of phase 3a trials. Diabet Med. 2013;30:226–32.
20. US Department of Health and Human Services FaDACfDEaR, US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for industry: diabetes mellitus: developing drugs and therapeutic biologies for treatment and prevention (draft guidance). 2008.
21. Riddle MC, Rosenstock J, Gerich J, Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26:3080–6.
22. Brod M, Christensen T, Bushnell DM. Impact of nocturnal hypoglycemic events on diabetes management, sleep quality, and next-day function: results from a four-country survey. J Med Econ. 2012;15:77–86.
23. Ware JE, Kosinski M, Bjorner JB, Turner-Bowker DM, Gandek B, Maruish ME. User’s manual for the SF-36v2 health survey. 2nd ed. Lincoln: QualityMetric Inc; 2007.