Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes

Current Medical Research and Opinion

Volumn 25, Issue 11, 2009, Pages 2679-2687

  Hompesch, Marcus ^a   Ocheltree, Scott M ^b   Wondmagegnehu, Eshetu T ^b   Morrow, Linda A ^a   Kollmeier, Alexa P ^a,c   Campaigne, Barbara N ^b,d   Jacober, Scott J ^b  

^a Clinical Research Institute Inc   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^d INDIANA UNIVERSITY   (United States)

Author keywords

Basal insulin analogs; Pharmacodynamics; Pharmacokinetics; Type 2 diabetes mellitus

Indexed keywords

GLUCOSE; HUMALOG MIX25; HUMALOG MIX50; HUMALOG MIX50 50; HUMAN INSULIN; IMMUNOREACTIVE INSULIN; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN LISPRO; INSULIN LISPRO PROTAMINE; PROTAMINE; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BOLUS INJECTION; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG DURATION OF ACTION; DRUG FORMULATION; DRUG ONSET OF ACTION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLUCOSE CLAMP TECHNIQUE; GLUCOSE INFUSION; HEADACHE; HUMAN; INFUSION RATE; INJECTION SITE PAIN; INSULIN BLOOD LEVEL; MALE; MAXIMUM PLASMA CONCENTRATION; MUSCULOSKELETAL PAIN; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SUSPENSION; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; AGED; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MIDDLE AGED; PROTAMINES; SUSPENSIONS;

EID: 72549110705     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007990903223739     Document Type: Article

References (17)

1. Roach P, Trautmann M, Arora V, et al.; Mix50 Study Group. Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro Mix25 and insulin lispro Mix50. Clin Ther 1999;21:523-534
2. Malone JK, Kerr LF, Campaigne BN, et al.; Lispro Mixture-Glargine Study Group. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther 2004;26:2034-2044
3. Rosenstock J, Ahmann A, Colon G, et al. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (lispro/ILPS) vs. basal/bolus (glargine/lispro) therapy. Diabetes Care 2008;31:21-25
4. Esposito K, Ciotola M, Maiorino MI, et al. Addition of neutral protamine lispro insulin or insulin glargine to oral type 2 diabetes regimens for patients with suboptimal glycemic control: a randomized trial. Ann Intern Med 2008;149:531-539
5. Klein O, Lynge J, Endahl L, et al. 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 2006;9:290-299 (Pubitemid 46502046)
6. Riddle MC, Rosenstock J, Gerich J, for the Insulin Glargine 4002 Study Investigators. 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
7. Holman RR, Thorne KI, Farmer AJ, et al.; 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007;357:1716-1730
8. Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006;49:442-451 (Pubitemid 43277866)
9. Hermansen K, Davies M, Derezinski T, et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006;29:1269-1274 (Pubitemid 44125921)
10. Rosenstock J, Davies M, Home PD, et al. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008;51:408-416
11. Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabetic Med 1998;15:539-553
12. Heinemann L. Time-action profiles of insulin preparations. Mainz, Germany: Verlag Kirchheim + Co. GmbH, 2004
13. Levemir Medical Review (Application Number 21-536), pages 15-16. Washington, DC: FDA/Center for Drug Evaluation and Research, 2005. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2005/021-536-Levemir-medr.PDF [Last accessed 21 August 2009]
14. Porcellati F, Rossetti P, Busciantella N, et al. Comparison of pharmacokinetics and dynamics of the long-acting insulin analogs glargine and detemir at steady state in type 1 diabetes mellitus: a double-blind, randomized, crossover study. Diabetes Care 2007;30:2447-2452 (Pubitemid 47547770)
15. Bock G, Wutte A, Kohler G, et al. Pharmacodynamics and pharmacokinetics of long-acting insulin analogues detemir and glargine after 7 days of use and after its first administration in subjects with type 1 diabetes. Diabetologia 2008;51(Suppl. 1):S390
16. 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
17. 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