Microneedle-based intradermal versus subcutaneous administration of regular human insulin or insulin lispro: Pharmacokinetics and postprandial glycemic excursions in patients with type 1 diabetes

Diabetes Technology and Therapeutics

Volumn 13, Issue 4, 2011, Pages 443-450

  Pettis, Ronald J ^a   Ginsberg, Barry ^a   Hirsch, Laurence ^a   Kapitza, Christoph ^b   Nosek, Leszek ^b   Hövelmann, Ulrike ^b   Kurth, Heinz Joerg ^b   Sutter, Diane E ^a   Harvey, Noel G ^a   Heinemann, Lutz ^b  

^a BD Technologies   (United States)

^b Profil Institut fur Stoffwechselforschung GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN INSULIN; INSULIN ASPART; INSULIN LISPRO;

ADULT; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG INDUCED HEADACHE; DRUG UPTAKE; EDEMA; GLUCOSE BLOOD LEVEL; GLUCOSE INFUSION; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; MALE; MAXIMUM PLASMA CONCENTRATION; MICRONEEDLE; NEEDLE; PAPULE; PHARMACODYNAMICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADOLESCENT; ADULT; AREA UNDER CURVE; BLOOD GLUCOSE; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; HUMANS; HYPOGLYCEMIC AGENTS; INJECTIONS, INTRADERMAL; INJECTIONS, SUBCUTANEOUS; INSULIN; MALE; MIDDLE AGED; NEEDLES; POSTPRANDIAL PERIOD; YOUNG ADULT;

EID: 79953209743     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2010.0183     Document Type: Article

References (19)

1. Giugliano D, Ceriello A, Razzoli E, Esposito K: Defining the role of insulin lispro in the management of postprandial hyperglycaemia in patients with type 2 diabetes mellitus. Clin Drug Investig 2008;28:199-210. (Pubitemid 351414745)
2. Gerich JE: Clinical significance, pathogenesis, and management of postprandial hyperglycemia. Arch Intern Med 2003;163:1306-1316. (Pubitemid 36676195)
3. Haffner SM: The importance of hyperglycaemia in the nonfasting state to the development of cardiovascular disease. Endocr Rev 1998;19:583-592. (Pubitemid 28467712)
4. Abbatecola AM, Paolisso G: Plasma glucose excursions in older persons with type 2 diabetes mellitus. J Endocrinol Invest 2005;28(11 Suppl Proceedings):105-107.
5. Gin H, Rigalleau V: Post-prandial hyperglycemia. Postprandial hyperglycemia and diabetes. Diabetes Metab 2000;26:265-272.
6. 1C. Diabetes Care 2003;26:881-885. (Pubitemid 36929359)
7. Davidson JA, Parkin CG: Is hyperglycemia a causal factor in cardiovascular disease? Does proving this relationship really matter? Yes. Diabetes Care 2009;32(Suppl 2):S331-S333.
8. Conget I, Gimenez M: Glucose control and cardiovascular disease: is it important? No. Diabetes Care 2009;32(Suppl 2):S334-S336.
9. DeFronzo R: Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes 2009;58:773-795.
10. Bonora E, Corrao G, Bagnardi V, Ceriello A, Comaschi M, Montanari P, Meigs JB: Prevalence and correlates of postprandial hyperglycaemia in a large sample of patients with type 2 diabetes mellitus. Diabetologia 2006;49:846-854.
11. Heinemann L: Insulin pump therapy: what is the evidence for using different types of boluses for coverage of prandial insulin requirements? J Diabetes Sci Technol 2009;3:1490-1500.
12. Plank J, Siebenhofer A, Berghold A, Jeitler K, Horvath K, Mrak P, Pieber TR: Systematic review and meta-analysis of short-acting insulin analogues in patients with diabetes mellitus. Arch Intern Med 2005;165:1337-1344. (Pubitemid 40973416)
13. Erlinger TP, Brancati FL: Postchallenge hyperglycemia in a national sample of US adults with type 2 diabetes. Diabetes Care 2001;24:1734-1738. (Pubitemid 33716474)
14. Pettis RJ: Microneedle Based Drug Delivery: A Promising Minimally Invasive Method for Parenteral Administration. Drug Delivery Companies Report, Spring/Summer. PharmaVentures, Ltd., Oxford, 2004.
15. Harvey A, Kaestner S, Sutter D, Harvey NG, Mikszta JA, Pettis RJ: Microneedle-based intradermal delivery enables rapid lymphatic uptake and distribution of protein drugs. Pharm Res 2010;28:107-116.
16. Pettis RJ, Ginsberg B, Hirsch L, Sutter D, Keith S, McVey E, Harvey NG, Hompesch M, Nosek L, Kapitza C, Heinemann L: Intradermal microneedle delivery of insulin lispro achieves faster insulin absorption and insulin action than subcutaneous injection. Diabetes Technol Ther 2011;13: 435-442.
17. AAMI Standards and Recommended Practices,Vol. 4: Biological Evaluation of Medical Devices: ISO 10993-10:2010, Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization. Association for the Advancement of Medical Instrumentation, Arlington, VA, 1997.
18. Gupta J, Felnere EI, Prausnitz MR: Minimally invasive insulin delivery in subjects with type 1 diabetes using hollow microneedles. Diabetes Technol Ther 2009;11:329-337.
19. Gibney MA, Arce CH, Byron KJ, Hirsch LJ: Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin 2010;26:1519-1530.