Insulin degludec/liraglutide: Innovation-driven combination for advancement in diabetes therapy

Expert Opinion on Biological Therapy

Volumn 14, Issue 6, 2014, Pages 869-878

  Kumar, Ajay ^a  

^a Diabetes Care and Research Center   (India)

Author keywords

Body weight changes; Diabetes mellitus; Drug combinations; Glucagon like peptide 1; Glycosylated; Hemoglobin A; Hypoglycemia; Insulin; Insulin degludec; Liraglutide; Long acting; Type 2

Indexed keywords

ANTIDIABETIC AGENT; DEGLIRA; GLUCOSE; INSULIN DEGLUDEC; INSULIN DEGLUDEC PLUS LIRAGLUTIDE; LIRAGLUTIDE; UNCLASSIFIED DRUG; BIOLOGICAL MARKER; DRUG COMBINATION; GLUCAGON LIKE PEPTIDE 1; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; LONG ACTING INSULIN;

ALGORITHM; ARTICLE; DIABETIC PATIENT; DRUG EFFICACY; DRUG SAFETY; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; NAUSEA; NOCTURNAL HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL (TOPIC); RISK BENEFIT ANALYSIS; SIDE EFFECT; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION; ANALOGS AND DERIVATIVES; ANIMAL; BLOOD; DIABETES MELLITUS, TYPE 2; DRUG COMBINATION; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; METABOLISM; TREATMENT OUTCOME;

ANIMALS; BIOLOGICAL MARKERS; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DRUG COMBINATIONS; GLUCAGON-LIKE PEPTIDE 1; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN, LONG-ACTING; TREATMENT OUTCOME;

EID: 84900821247     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2014.904851     Document Type: Article

References (58)

1. International Diabetes Federation. Diabetes Atlas. 5th edition. International Diabetes Federation, Brussels; 2011. Available from: http://www.idf. org/diabetesatlas/5e/the-global-burden [Last accessed: 5 March 2014]
2. Chan JL, Abrahamson MJ. Pharmacological management of type 2 diabetes mellitus: rationale for rational use of insulin. Mayo Clin Proc 2003;78:459-67
3. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2009;52:17-30
4. Garber AJ, Abrahamson MJ, Barzilay JI, et al. American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract 2013;19:327-36
5. 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;35:1364-79
6. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care 2003;26:1902-12
7. Korytkowski M. When oral agents fail: practical barriers to starting insulin. Int J Obes 2002;26(Suppl 3):S18-24
8. Nauck MA, Kleine N, Orskov C, et al. Normalization of fasting hyperglycaemia by exogenous glucagon-like peptide 1 (7-36 amide) in type 2 (non-insulin-dependent) diabetic patients. Diabetologia 1993;36(8):741-4
9. White J. Efficacy and safety of incretin based therapies: clinical trial data. J Am Pharm Assoc 2009;49(Suppl 1):S30-40
10. Bunck MC, Cornér A, Eliasson B, et al. Effects of exenatide on measures of beta-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care 2011;34:2041-7
11. Buse J, Rosenstock J, Sesti G, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 2009;374:39-47
12. DeVries JH, Bain SC, Rodbard HW, et al. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care 2012;35:1446-54
13. Arnolds S, Dellweg S, Clair J, et al. Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study. Diabetes Care 2010;33:1509-15
14. Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med 2011;154:103-12
15. Raccah D. Options for the intensification of insulin therapy when basal insulin is not enough in type 2 diabetes mellitus. Diabetes Obes Metab 2008;10(Suppl 2):76-82
16. Buse JB, Gough SC, Woo VC, et al. 2013; IDegLira, a novel fixed ratio combination of insulin Degludec and Liraglutide, is efficacious and safe in subjects with type 2 diabetes: a large, randomized phase 3 trial. ADA 73rd annual conference, Chicago, IL, USA; 2013. p. 65-OR
17. Zinman B, Philis-Tsimikas A, 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
18. Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care 2010;33:240-5
19. Gautam CS, Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. Br J Clin Pharmacol 2008;65(5):795-6
20. Buse JB, Vilsbøll T, Thurman J, et al. 2013; Liraglutide contributes significantly to glycaemic control achieved in IDegLira: a double-blind Phase 3 trial in type 2 diabetes. The World Diabetes Congress, Melbourne, Australia; 2013. p. OP-0082
21. Wakil A, Atkin SL. Efficacy and safety of ultra-long-acting insulin degludec. Ther Adv Endocrinol Metab 2012;3:55-9
22. 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 2012;29:2104-14
23. Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther 2012;12:1533-40
24. Agerso H, Jensen LB, Elbrond B, et al. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia 2002;45:195-202
25. Agerso H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci 2003;19:141-50
26. Available from: http://www.rxlist.com/victoza-drug.htm [Last accessed 5 March 2014]
27. Jonassen I, Havelund S, Ribel U, et al. Insulin degludec: multi-hexamer formation is the underlying basis for this new generation ultra-long acting basal insulin. Diabetologia 2010;53:S388
28. Heise T, Hovelmann U, Nosek L, et al. Insulin degludec: two-fold longer half-life and a more consistent pharmacokinetic profile than insulin glargine. Diabetologia 2011;54:S425
29. Rendell M. Insulin degludec: a long-acting modern insulin analogue with a predictable pharmacokinetic/pharmacodynamic profile. Drugs Today (Barc) 2013;49:387-97
30. 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 2012;14:859-64
31. Elbrønd B, Jakobsen G, Larsen S, et al. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a longacting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care 2002;25:1398-404
32. 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
33. 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 individuals with type 2 diabetes. Diabetes Care 2013;36:858-64
34. Riddle MC, Aronson R, Home P, et al. Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled by Established Basal Insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care 2013;36:2489-96
35. 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
36. Garber AJ, King AB, Del PS, et al. Insulin degludec, an ultra-long-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, openlabel, treat-to-target non-inferiority trial. Lancet 2012;379:1498-507
37. Zinman B, Fulcher G, Rao PV, et al. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet 2011;377:924-31
38. 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(2):175-84
39. Birkeland KI, Home PD, Wendisch U, et al. Insulin degludec in type 1 diabetes: randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care 2011;34:661-5
40. Iwamoto Y, Clauson P, Nishida T, et al. Insulin degludec in Japanese patients with type 1 diabetes mellitus: a randomized controlled trial. J Diabetes Invest 2013;4(1):62-8
41. Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet 2006;368:1696-705
42. Garber A, Henry R, Ratner R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet 2009;373:473-81
43. Nauck MA, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009;32:84-90
44. Marre M, Shaw J, Brandle M, et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). Diabet Med 2009;26:268-78
45. Zinman B, Gerich J, Buse J, et al. Efficacy and safety of the human GLP-1 analog liraglutide in combination with metformin and TZD in patients with type 2 diabetes mellitus (LEAD-4 Met +TZD). Diabetes Care 2009;32:1224-30
46. Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulphonylurea therapy in type 2 diabetes mellitus: a randomised controlled trial (LEAD-5 met+SU). Diabetologia 2009;52:2046-55
47. ADA/EASD/IDF Statement Concerning the Use of Incretin Therapy and Pancreatic Disease, press release. Available from: http://www.diabetes.org/ newsroom/press-releases/2013/recommendations-for.html Alexandria, VA, June 28, 2013 [Last accessed 5 March 2014]
48. Rolin B, Larsen MO, Gotfredsen CF, et al. The long-acting GLP-1 derivative NN2211 ameliorates glycemia and increases beta-cell mass in diabetic mice. Am J Physiol Endocrinol Metab 2002;283:E745-52
49. Sturis J, Gotfredsen CF, Rømer J, et al. GLP-1 derivative liraglutide in rats with beta-cell deficiencies: influence of metabolic state on beta-cell mass dynamics. Br J Pharmacol 2003;140:123-32
50. Repas T. Next-generation GLP-1 therapy: an introduction to liraglutide. Postgrad Med 2011;123(5):239-47
51. Buse JB, Sesti G, Schmidt WE, et al. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care 2010;33:1300-3
52. Astrup A, Carraro R, Finer N, et al. NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond) 2012;36(6):843-54
53. Available from: http://www.novonordisk.com/include/asp/exe-news- attachment.asp?sAttachmentGUID=FA7E1CC8-2DB2-41B3-ADA1-9F40C8DA2226 [Last accessed 5 March 2014]
54. Riddle M, Ahmann A, Basu A, et al. Metformin+exenatide+basal insuiln vs metformin+placebo+basal insulin: reaching A1c <6.5% without weight-gain or serious hypoglycemia (Abstract 18-LB). Diabetes 2010;59
55. Seino Y, Min KW, Niemoeller E, Takami A. Randomized, doubleblind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab 2012;14:910-17
56. Available from: http://clinicaltrials.gov/ct2/show/NCT01676116? term=NCT01676116&rank=1 [Last accessed 5 March 2014]
57. Available from: http://clinicaltrials.gov/ct2/show/NCT01618162? term=NCT01618162&rank=1 [Last accessed 5 March 2014]
58. Available from: http://clinicaltrials.gov/ct2/show/NCT01952145?term= NCT01952145&rank=1 [Last accessed 5 March 2014]