Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus

Diabetes Therapy

Volumn 5, Issue 1, 2014, Pages 255-265

  Heise, Tim ^a   Nosek, Leszek ^a   Roepstorff, Carsten ^b   Chenji, Suresh ^c   Klein, Oliver ^a   Haahr, Hanne ^b  

^a Profil Institute for Metabolic Research   (Germany)

^b NOVO NORDISK A S   (Denmark)

^c Raheja Towers   (India)

Author keywords

Insulin degludec insulin aspart; Pharmacodynamics; Pharmacokinetics; Steady state; Type 1 diabetes mellitus

Indexed keywords

INSULIN ASPART; INSULIN DEGLUDEC; NEUTRAL INSULIN;

ABSENCE OF SIDE EFFECTS; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAPHY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INFUSION RATE; INSULIN DEPENDENT DIABETES MELLITUS; MALE; OPEN STUDY; PHARMACODYNAMICS; PRIORITY JOURNAL; STEADY STATE;

EID: 84920936584     PISSN: 18696953     EISSN: 18696961     Source Type: Journal    
DOI: 10.1007/s13300-014-0070-2     Document Type: Article

References (30)

1. 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;29:682–9.
2. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia 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). Diabetologia. 2012;55:1577–96.
3. Riddle MC, Rosenstock J, Vlajnic A, Gao L. Randomized, 1-year comparison of three ways to initiate and advance insulin for type 2 diabetes: twice-daily premixed insulin versus basal insulin with either basal-plus one prandial insulin or basal-bolus up to three prandial injections. Diabetes Obes Metab. 2014;16:396–402.
4. Giugliano D, Maiorino MI, Bellastella G, Chiodini P, Cerriello A, Esposito K. Efficacy of insulin analogs in achieving the haemoglobin A1c target of <7% in type 2 diabetes: meta-analysis of randomised controlled trials. Diabetes Care. 2011;34:510–7.
5. Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER study: a randomized controlled trial. Diabetes Obes Metab. 2009;11:45–52.
6. Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008;10:479–85.
7. Hirao K, Maeda H, Urata S, et al. Comparison of the pharmacokinetic and pharmacodynamic profiles of biphasic insulin aspart 50 and 30 in patients with type 2 diabetes mellitus: a single-center, randomized, double-blind, two-period, crossover trial in Japan. Clin Ther. 2007;29:927–34.
8. Rave K, Heinemann L, Puhl L, et al. Premixed formulations of insulin lispro. Activity profiles in type 1 diabetic patients. Diabetes Care. 1999;22:865–6.
9. Heise T, Weyer C, Serwas A, et al. Time-action profiles of novel premixed preparations of insulin lispro and NPL insulin. Diabetes Care. 1998;21:800–3.
10. Weyer C, Heise T, Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care. 1997;20:1612–4.
11. Cengiz E, Swan KL, Tamborlane WV, Sherr JL, Martin M, Weinzimer SA. The alteration of aspart insulin pharmacodynamics when mixed with detemir insulin. Diabetes Care. 2012;35:690–2.
12. Ryzodeg Summary of Product Characteristics. Novo Nordisk A/S. At: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002499/WC500139011.pdf. Accessed on April 25, 2014.
13. Kurtzhals P, Heise T, Strauss HM, et al. Multi-hexamer formation is the underlying basis for the ultra-long glucose-lowering effect of insulin degludec. Diabetologia. 2011;54(suppl 1):S426.
14. 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.
15. Havelund S, Ribel U, Hubálek F, et al. Insulin degludec (IDeg) and insulin aspart (IAsp) can be co-formulated such that the formation of IDeg multi-hexamers and IAsp monomers is retained upon s.c. injection. Diabetes 2013;62(suppl 1):A241:945-P.
16. Heinemann L, Heise T, Jorgensen LN, Starke AA. Action profile of the rapid acting insulin analogue: human insulin B28Asp. Diabet Med. 1993;10:535–9.
17. Korsatko S, Deller S, Mader JK, Glettler K, Koehler G, Treiber G, Urschitz M, Wolf M, Hastrup H, Søndergaard F, Haahr H, Pieber TR. Ultra-long pharmacokinetic properties of insulin degludec are comparable in elderly subjects and younger adults with type 1 diabetes mellitus. Drugs Aging. 2014;31:47–53.
18. 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.
19. Salsali A, Nathan M. A review of types 1 and 2 diabetes mellitus and their treatment with insulin. Am J Ther. 2006;13:349–61.
20. Coester H-V, Heise T, Nosek L, Roepstorff C, Segel S, Lassota N, Haahr HL. Steady state is reached within two to three days of once-daily administration of ultra-long-acting insulin degludec. Diabetologia. 2012;55(suppl 1):909.
21. American Diabetes Association. Standards of medical care in diabetes – 2012. Diabetes Care. 2012;35(suppl 1):S11–63.
22. Lepore M, Pampanelli S, Fanelli C, et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes. 2000;49(12):2142–8.
23. 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.
24. ® Summary of Product Characteristics. Novo Nordisk A/S. At: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002498/WC500138940.pdf. Accessed on April 25, 2014.
25. Vaag A, Lund S. Insulin initiation in patients with type 2 diabetes mellitus: treatment guidelines, clinical evidence and patterns of use of basal vs premixed insulin analogues. Eur J Endocrinol. 2012;166:159–70.
26. Garber AJ. Insulin intensification strategies in type 2 diabetes: when one injection is no longer sufficient. Diabetes Obes Metab. 2009;11:14–8.
27. Fulcher GR, Christiansen JS, Bantwal G, Polaszewska-Muszynska M, Mersebach H, Andersen TH, Niskanen LK, on behalf of the BOOST: Intensify Premix I investigators. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care; 2014. doi:10.2337/dc13-2908.
28. Christiansen JS, Chow FCC, Choi DS, Taneda S, Hirao K. Superior FPG control and less nocturnal hypoglycaemia with IDegAsp vs BIAsp 30 in Asian subjects poorly controlled on basal or pre/self-mixed insulin: randomised phase 3 trial. Diabetologia. 2013;56:S420.
29. Vaag A, Christiansen JS, Niskanen L, Rasmussen S, Johansen T, Fulcher G. Lower rates of overall, nocturnal and severe hypoglycaemia during maintenance treatment with IDegAsp vs biphasic insulin aspart 30 in patients with type 2 diabetes mellitus: a meta-analysis. Diabetologia. 2013;56:S83.
30. Heise T, Nosek L, Coester HV, et al. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes. Poster presented at International Diabetes Federation, 2–6 December 2013, Melbourne, Australia. Poster P-1400.