Morning administration of 0.4 U/kg/day insulin glargine 300 U/mL provides less fluctuating 24-hour pharmacodynamics and more even pharmacokinetic profiles compared with insulin degludec 100 U/mL in type 1 diabetes

Diabetes and Metabolism

Volumn 44, Issue 1, 2018, Pages 15-21

  Bailey, T S ^a   Pettus, J ^b   Roussel, R ^c,d,e   Schmider, W ^f   Maroccia, M ^g   Nassr, N ^f   Klein, O ^h   Bolli, G B ⁱ   Dahmen, R ^f  

^a AMCR Institute   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c CENTRE DE RECHERCHE DES CORDELIERS   (France)

^d UNIVERSITÉ PARIS DESCARTES   (France)

^e BICHAT HOSPITAL   (France)

^f SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

^g Umanis Clinical Research   (France)

^h Profil   (Germany)

ⁱ UNIVERSITY OF PERUGIA   (Italy)

Author keywords

Insulin degludec; Insulin glargine; Pharmacodynamic; Pharmacokinetic; Type 1 diabetes

Indexed keywords

DEG 100; GLA 300; INSULIN DEGLUDEC; INSULIN GLARGINE; ANTIDIABETIC AGENT; LONG ACTING INSULIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; FEMALE; GLUCOSE INFUSION; HUMAN; HYPOGLYCEMIA; INSULIN BLOOD LEVEL; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MALE; MAXIMUM CONCENTRATION; MEAL; MORNING DOSAGE; PHARMACODYNAMICS; PHARMACOKINETIC PARAMETERS; RADIOIMMUNOASSAY; RANDOMIZED CONTROLLED TRIAL; SEIZURE; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; VESTIBULAR NEURONITIS; ADOLESCENT; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; DIABETES MELLITUS, TYPE 1; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN GLARGINE; INSULIN, LONG-ACTING; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 85034448595     PISSN: 12623636     EISSN: 18781780     Source Type: Journal    
DOI: 10.1016/j.diabet.2017.10.001     Document Type: Article

References (20)

1. Bolli, G.B., Gottesman, I.S., Cryer, P.E., Gerich, J.E., Glucose counterregulation during prolonged hypoglycemia in normal humans. Am J Physiol 247 (1984), E206–E214.
2. Gerich, J., Becker, R.H., Zhu, R., Bolli, G.B., Fluctuation of serum basal insulin levels following single and multiple dosing of insulin glargine. Diabetes Technol Ther 8 (2006), 237–243.
3. Becker, R.H., Dahmen, R., Bergmann, K., Lehmann, A., Jax, T., Heise, T., New insulin glargine 300 Units. mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units. mL-1. Diabetes Care 38 (2015), 637–643.
4. Heise, T., Hövelmann, U., Nosek, L., Hermanski, L., Bøttcher, S.G., Haahr, H., Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol 11 (2015), 1193–1201.
5. Ritzel, R., Roussel, R., Bolli, G.B., Vinet, L., Brulle-Wohlhueter, C., Glezer, S., et al. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 2 diabetes. Diabetes Obes Metab 17 (2015), 859–867.
6. Ratner, R.E., Gough, S.C., Mathieu, C., Del Prato, S., Bode, B., Mersebach, H., 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 15 (2013), 175–184.
7. Home, P.D., Bergenstal, R.M., Bolli, G.B., Ziemen, M., Rojeski, M., Espinasse, M., et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care 38 (2015), 2217–2225.
8. Benesch, C., Heise, T., Klein, O., Heinemann, L., Arnolds, S., How to assess the quality of glucose clamps? Evaluation of clamps performed with ClampArt, a novel automated clamp device. J Diabetes Sci Technol 9 (2015), 792–800.
9. Bolli, G.B., Hahn, A.D., Schmidt, R., Eisenblaetter, T., Dahmen, R., Heise, T., et al. Plasma exposure to insulin glargine and its metabolites M1 and M2 after subcutaneous injection of therapeutic and supratherapeutic doses of glargine in subjects with type 1 diabetes. Diabetes Care 35 (2012), 2626–2630.
10. Matsuhisa, M., Koyama, M., Cheng, X., Takahashi, Y., Riddle, M.C., Bolli, G.B., et al. New insulin glargine 300 U/mL versus glargine 100 U/mL in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab 18 (2016), 375–383.
11. Marso, S.P., McGuire, D.K., Zinman, B., Poulter NR4, Emerson, S.S., Pieber, T.R., et al. Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs. Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) – DEVOTE 1. Am Heart J 179 (2016), 175–183.
12. Bergenstal, R.M., Bailey, T.S., Rodbard, D., Ziemen, M., Guo, H., Muehlen-Bartmer, I., et al. Comparison of insulin glargine 300 U/mL and 100 U/mL in adults with type 1 diabetes: continuous glucose monitoring profiles and variability using morning or evening injections. Diabetes Care 40 (2017), 554–560, 10.2337/dc16-0684.
13. Monnier, L., Owens, D.R., Bolli, G.B., The new long-acting insulin glargine U300 achieves an early steady state with low risk of accumulation. Diabetes Metab 42 (2016), 77–79.
14. Steinstraesser, A., Schmidt, R., Bergmann, K., Dahmen, R., Becker, R.H., Investigational new insulin glargine 300 U/mL has the same metabolism as insulin glargine 100 U/mL. Diabetes Obes Metab 16 (2014), 873–876.
15. Scholtz, H.E., Pretorius, S.G., Wessels, D.H., Venter, C., Potgieter, M.A., Becker, R.H., Equipotency of insulin glargine and regular human insulin on glucose disposal in healthy subjects following intravenous infusion. Acta Diabetol 40 (2003), 156–162.
16. Terauchi, Y., Koyama, M., Cheng, X., Takahashi, Y., Riddle, M.C., Bolli, G.B., et al. New insulin glargine 300 U/mL versus glargine 100 U/mL in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab 18 (2016), 366–374.
17. Heller, S., Buse, J., Fisher, M., Garg, S., Marre, M., Merker, L., 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 379 (2012), 1489–1497.
18. Mathieu, C., Hollander, P., Miranda-Palma, B., Cooper, J., Franek, E., Russell-Jones, D., 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 98 (2013), 1154–1162.
19. Heise, T., Nørskov, M., Nosek L1, Kaplan, K., Famulla, S., Haahr, H.L., Insulin degludec: lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab 19 (2017), 1032–1039.
20. Porcellati, F., Lucidi, P., Cioli, P., Candeloro, P., Marinelli Andreoli, A., Marzotti, S., et al. Pharmacokinetics and pharmacodynamics of insulin glargine given in the evening as compared with in the morning in type 2 diabetes. Diabetes Care 38 (2015), 503–512.