Fast-acting insulin aspart improves glycemic control in basal-bolus treatment for type 1 diabetes: Results of a 26-week multicenter, active-controlled, treat-to-target, randomized, parallel-group trial (onset 1)

Diabetes Care

Volumn 40, Issue 7, 2017, Pages 943-950

  Russell Jones, David ^a   Bode, Bruce W ^b   De Block, Christophe ^c   Franek, Edward ^d   Heller, Simon R ^e   Mathieu, Chantal ^f   Philis Tsimikas, Athena ^g   Rose, Ludger ^h   Woo, Vincent C ⁱ   Østerskov, Anne Birk ^j   Graungaard, Tina ^j   Bergenstal, Richard M ^k  

^a UNIVERSITY OF SURREY   (United Kingdom)

^b Atlanta Diabetes Association   (United States)

^c ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^d MOSSAKOWSKI MEDICAL RESEARCH CENTRE   (Poland)

^e UNIVERSITY OF SHEFFIELD   (United Kingdom)

^f UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^g SCRIPPS HEALTH   (United States)

^h Diabetes Research Center   (Germany)

ⁱ UNIVERSITY OF MANITOBA   (Canada)

^j NOVO NORDISK A S   (Denmark)

^k INTERNATIONAL DIABETES CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; INSULIN ASPART; INSULIN DETEMIR; GLYCOSYLATED HEMOGLOBIN;

ADULT; CONFERENCE PAPER; CONTROLLED STUDY; DISEASE SEVERITY; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INJECTION SITE REACTION; INSULIN DEPENDENT DIABETES MELLITUS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL; BIOASSAY; BLOOD; BODY MASS; CLINICAL TRIAL; DOSE RESPONSE; MEAL; METABOLISM; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; POSTPRANDIAL STATE;

ADULT; BLOOD GLUCOSE; BODY MASS INDEX; DIABETES MELLITUS, TYPE 1; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; FEMALE; GLYCATED HEMOGLOBIN A; HUMANS; HYPOGLYCEMIA; INSULIN ASPART; INSULIN DETEMIR; MALE; MEALS; MIDDLE AGED; POSTPRANDIAL PERIOD;

EID: 85020601911     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc16-1771     Document Type: Conference Paper

References (34)

1. American Diabetes Association. Standards of Medical Care in Diabetes-2016. Diabetes Care 2016;39(Suppl. 1):S1-S108
2. Rydén L, Grant PJ, Anker SD, et al.; Authors/Task Force Members; ESCCommittee for Practice Guidelines (CPG); Document Reviewers. ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J 2013;34:3035-3087
3. International Diabetes Federation Guideline Development Group. Guideline for management of postmeal glucose in diabetes. Diabetes Res Clin Pract 2014;103:256-268
4. Nathan DM. Long-termcomplications of diabetes mellitus. N Engl J Med 1993;328:1676-1685
5. Nathan DM, Cleary PA, Backlund JY, et al.; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353:2643-2653
6. Nathan DM; DCCT/EDIC Research Group. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study at 30 years: overview. Diabetes Care 2014;37:9-16
7. Luijf YM, van Bon AC, Hoekstra JB, Devries JH. Premeal injection of rapid-acting insulin reduces postprandial glycemic excursions in type 1 diabetes. Diabetes Care 2010;33:2152-2155
8. Sanofi Aventis. Apidra (insulin glulisine): summary of product characteristics [article online]. Available from http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000557/WC500025250.pdf. Accessed 16 August 2016
9. Eli Lilly. Humalog (insulin lispro): summary of product characteristics [article online]. Available from http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000088/WC500050332.pdf. Accessed 16 August 2016
10. Novo Nordisk. NovoRapid (insulin aspart): summary of product characteristics [article online]. Available fromhttp://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000258/WC500030372.pdf. Accessed 16 August 2016
11. Andersen G, Alluis B, Meiffren G, et al. Ultrarapid BioChaperone insulin Lispro (BC-LIS): linear dose-response and faster absorption than insulin Lispro (LIS). Diabetologia 2015;58(Suppl. 1):S449
12. Boss AH, Petrucci R, Lorber D. Coverage of prandial insulin requirements by means of an ultra-rapid-acting inhaled insulin. J Diabetes Sci Technol 2012;6:773-779
13. Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv 2007;4:427-440
14. Heinemann L, Hompesch M, Flacke F, et al. Reduction of postprandial glycemic excursions in patients with type 1 diabetes: a novel human insulin formulation versus a rapid-acting insulin analog and regular human insulin. J Diabetes Sci Technol 2011;5:681-686
15. Hirsch IB, Bode BW, Skyler JS, Garg SK, Buse JB, WUXW, Vaugh DE, Muchmore DB. Recombinant human hyaluronidase pretreatment of CSII cannula sites provides comparable glycemic control with reduced hypoglycemia in T1DM compared to usual CSII (Abstract). Diabetes 2014;63(Suppl. 1):85-LB
16. Hompesch M, Muchmore DB, Morrow L, Vaughn DE. Accelerated insulin pharmacokinetics and improved postprandial glycemic control in patients with type 1 diabetes after coadministration of prandial insulins with hyaluronidase. Diabetes Care 2011;34:666-668
17. Krasner A, Brazg R, Blevins T. Safety and efficacy of ultra-rapid-acting human insulin formulation BIOD-123 in patients with type 1 diabetes (Abstract). Diabetes 2014;63(Suppl. 1):A34
18. Morrow L, Canney L, Pichotta P, Krasner A, Hompesch M, De Souza E. BIOD-531 demonstrates superior prandial glucose control, postmeal dosing flexibility, and less insulin "stacking" compared to marketed prandial/basal insulins. Diabetologia 2015;58(Suppl. 1):A6
19. Buckley ST, Kildegaard J, Høiberg-Nielsen R, et al.Mechanistic analysis into themode of action of niacinamide in faster-acting insulin aspart (Abstract). Diabetes Technol Ther 2016;18(Suppl. 1): A291
20. Heise T, Pieber TR,Danne T, Erichsen L,Haahr H. A pooled analysis of clinical pharmacology trials investigating the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in adults with type 1 diabetes. Clin Pharmacokinet 2017;56:551-559
21. Bowering K, Case C, Harvey J, et al. Faster aspart versus insulin aspart as part of a basalbolus regimen in inadequately controlled type 2 diabetes: the onset 2 trial. Diabetes Care 2017; 40:951-957
22. Rodbard H, Tripathy D, Vidrio-Vel ázquez M, Demissie M, Can Tamer S, Piletič M. Adding faster-acting insulin aspart to basal insulin significantly improved glycemic control: the onset 3 trial (Abstract). Diabetes 2016;65(Suppl. 1):A64
23. 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
24. World Medical Association. WMA Declaration of Helsinki: ethical principles for medical research involving human subjects [article online], 2013. Available from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethicalprinciples-for-medical-research-involving-humansubjects/. Accessed 16 August 2016
25. European Medicines Society. Guideline for Good Clinical Practice E6(R1) [Internet], 1996. Available from http://www.ema.europa .eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002874.pdf. Accessed 16 August 2016
26. Seaquist ER, 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 2013;36:1384-1395
27. Fullerton B, Siebenhofer A, Jeitler K, et al. Short-acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus. Cochrane Database Syst Rev 2016;6: CD012161
28. Home PD, Lindholm A, Riis A; European Insulin Aspart Study Group. Insulin aspart vs. human insulin in the management of long-term blood glucose control in type 1 diabetes mellitus: a randomized controlled trial. Diabet Med 2000;17:762-770
29. Raskin P, Guthrie RA, Leiter L, Riis A, Jovanovic L. Use of insulin aspart, a fast-acting insulin analog, as the mealtime insulin in the management of patients with type 1 diabetes. Diabetes Care 2000;23:583-588
30. Cengiz E. Undeniable need for ultrafastacting insulin: the pediatric perspective. J Diabetes Sci Technol 2012;6:797-801
31. Ligthelm RJ, Kaiser M, Vora J, Yale J-F. Insulin use in elderly adults: risk of hypoglycemia and strategies for care. J Am Geriatr Soc 2012; 60:1564-1570
32. Bode BW, Hyveled L, Tamer SC, Ybanez P, Demissie M. Improved postprandial glycemic control with faster-acting insulin aspart in subjects with type 1 diabetes using CSII. Diabetes Technol Ther 2017;19:25-33
33. Heise T, Hövelmann U, Brøndsted L, Adrian CL, Nosek L, Haahr H. Faster-acting insulin aspart: earlier onset of appearance and greater early pharmacokinetic and pharmacodynamic effects than insulin aspart. Diabetes Obes Metab 2015;17:682-688
34. Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, BodeBW. Compatibility and safety of faster-acting insulin aspart used in continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes. Endocr Rev 2016; 37(Suppl. 2):FRI697