Steady-state pharmacokinetics and glucodynamics of the novel, long-acting basal insulin LY2605541 dosed once-daily in patients with type 2 diabetes mellitus

Diabetes, Obesity and Metabolism

Volumn 16, Issue 4, 2014, Pages 344-350

  Sinha, V P ^a   Howey, D C ^a   Choi, S L ^a   Mace, K F ^a   Heise, T ^b  

^a ELI LILLY AND COMPANY   (United States)

^b Profil   (Germany)

Author keywords

Insulin analogues; Pharmacodynamics; Pharmacokinetics; Type 2 diabetes

Indexed keywords

ALANINE AMINOTRANSFERASE; BILIRUBIN; GLUCOSE; HUMAN INSULIN; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN PEGLISPRO; SHORT ACTING INSULIN; ANTIDIABETIC AGENT; C PEPTIDE; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; INSULIN LISPRO; MACROGOL DERIVATIVE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; BEDTIME DOSAGE; BILIRUBIN BLOOD LEVEL; CLINICAL ARTICLE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLUCOSE BLOOD LEVEL; GLUCOSE CLAMP TECHNIQUE; GLUCOSE INFUSION; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INJECTION SITE REACTION; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; MORNING DOSAGE; MULTIPLE DRUG DOSE; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PARALLEL DESIGN; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; SIDE EFFECT; SINGLE DRUG DOSE; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; ADOLESCENT; CHEMICALLY INDUCED; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION; DRUG EFFECTS; METABOLISM; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; AREA UNDER CURVE; BLOOD GLUCOSE; C-PEPTIDE; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCOSE CLAMP TECHNIQUE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN LISPRO; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; TREATMENT OUTCOME;

EID: 84895133323     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12222     Document Type: Article

References (20)

1. Riddle MC, Rosenstock J, Gerich J. 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: 3080-3086.
2. Buse JB, Wolffenbuttel BH, Herman WH et al. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care 2009; 32: 1007-1013.
3. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193-203.
4. Swinnen SG, Hoekstra JB, Devries JH. Insulin therapy for type 2 diabetes. Diabetes Care 2009; 32(Suppl. 2): S253-S259.
5. 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: 2142-2148.
6. Klein O, Lynge J, Endahl L, Damholt B, Nosek L, Heise T. Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab 2007; 9: 290-299.
7. Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes Obes Metab 2007; 9: 648-659.
8. Hirsch IB. Insulin analogues. N Engl J Med 2005; 352: 174-183.
9. Ashwell SG, Amiel SA, Bilous RW et al. Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes. Diabet Med 2006; 23: 285-292.
10. Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to neutral protamine Hagedorn insulin in patients with type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med 2008; 25: 442-449.
11. Heise T, Nosek L, Ronn BB et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004; 53: 1614-1620.
12. Hansen RJ, Cutler GB, Vick A, Koester A, Li S, Siesky AM, Beals JM. LY2605541: leveraging hydrodynamic size to develop a novel basal insulin. Poster 896-P at the 72nd Scientific Sessions of the American Diabetes Association (ADA). 2012.
13. Moore MC, Smith MS, Mace KF et al. Novel PEGylated insulin LY2605541 has a hepatic preferential effect on glucose metabolism (abstract). Diabetes 2012; 61(Suppl. 1): A417.
14. Smith BP, Vandenhende FR, DeSante KA et al. Confidence interval criteria for assessment of dose proportionality. Pharm Res 2000; 17: 1278-1283.
15. Heise T, Hovelmann U, Nosek L, Bottcher SG, Granhall C, Haahr H. Insulin degludec: two-fold longer half-life and more consistent pharmacokinetic profile than insulin glargine. Diabetologia 2011; 54(Suppl. 1): 1046.
16. Danne T, Lupke K, Walte K, Von SW, Gall MA. Insulin detemir is characterized by a consistent pharmacokinetic profile across age-groups in children, adolescents, and adults with type 1 diabetes. Diabetes Care 2003; 26: 3087-3092.
17. Brunner GA, Sendhofer G, Wutte A et al. Pharmacokinetic and pharmacodynamic properties of long-acting insulin analogue NN304 in comparison to NPH insulin in humans. Exp Clin Endocrinol Diabetes 2000; 108: 100-105.
18. Porcellati F, Rossetti P, Busciantella NR et al. Comparison of pharmacokinetics and dynamics of the long-acting insulin analogs glargine and detemir at steady state in type 1 diabetes: a double-blind, randomized, crossover study. Diabetes Care 2007; 30: 2447-2452.
19. Bergenstal RM, Rosenstock J, Arakaki RF et al. A randomized, controlled study of once daily LY2605541, a novel long-acting basal insulin, versus insulin glargine in basal insulin-treated patients with type 2 diabetes. Diabetes Care 2012; 35: 2140-2147.
20. Rosenstock J, Bergenstal RM, Blevins TC et al. Better glycemic control and weight loss with the novel long-acting basal insulin LY2605541 compared with insulin glargine in type 1 diabetes: a randomized, crossover study. Diabetes Care 2013; 36: 522-528.