PMID- 21355716
OWN - NLM
STAT- MEDLINE
DCOM- 20110803
LR  - 20111117
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 13
IP  - 4
DP  - 2011 Apr
TI  - Microneedle-based intradermal versus subcutaneous administration of regular human 
      insulin or insulin lispro: pharmacokinetics and postprandial glycemic excursions 
      in patients with type 1 diabetes.
PG  - 443-50
LID - 10.1089/dia.2010.0183 [doi]
AB  - BACKGROUND: This study assessed pharmacokinetics (PK) and pharmacodynamic 
      postprandial glycemia (PPG) in patients with type 1 diabetes mellitus (T1DM) 
      after a standardized liquid meal following insulin lispro (IL) or regular human 
      insulin (RHI) given by microneedle-based intradermal (ID) versus subcutaneous 
      (SC) delivery. RESEARCH DESIGN AND METHODS: In this randomized, open-label, 
      five-way crossover study, 29 T1DM patients received IL and RHI (0.125 U/kg) at 2 
      min and 17 min premeal, respectively, by both the SC and ID routes and also 
      received RHI by the ID route at 2 min premeal. Blood glucose was stabilized at 
      120 mg/dL prior to a standardized 82-g carbohydrate liquid meal. ID delivery used 
      a 34-gauge 1.5-mm steel microneedle, and SC delivery used a 31-gauge 8-mm syringe 
      needle. RESULTS: The 90-min PPG (blood glucose area under the curve for 0-1.5 h) 
      for ID RHI was 14% lower than SC RHI at -17 min (P < 0.0001) and 11% lower than 
      ID RHI at -2 min (P = 0.0006). PPG did not differ between ID RHI and SC IL, both 
      at -2 min (P = 0.8345). ID IL PPG was lower than SC, both at -2 min, but not 
      significantly (P = 0.10). Both ID IL and ID RHI PK data showed significantly 
      faster uptake and time to maximum concentration, higher maximum concentration, 
      and shorter systemic circulating duration versus SC dosing. ID IL and RHI 
      delivery was generally well tolerated. CONCLUSIONS: PPG with RHI administered ID 
      via microneedle was improved versus SC delivery when dosed 17 min premeal. ID RHI 
      provided similar control of PPG as SC IL immediately premeal. Further studies of 
      ID insulin delivery via steel microneedles are warranted.
FAU - Pettis, Ronald J
AU  - Pettis RJ
AD  - BD Technologies, Research Triangle Park, North Carolina 27709, USA. 
      rpettis@bd.com
FAU - Hirsch, Laurence
AU  - Hirsch L
FAU - Kapitza, Christoph
AU  - Kapitza C
FAU - Nosek, Leszek
AU  - Nosek L
FAU - Hovelmann, Ulrike
AU  - Hovelmann U
FAU - Kurth, Heinz-Joerg
AU  - Kurth HJ
FAU - Sutter, Diane E
AU  - Sutter DE
FAU - Harvey, Noel G
AU  - Harvey NG
FAU - Heinemann, Lutz
AU  - Heinemann L
LA  - eng
SI  - ClinicalTrials.gov/NCT00553488
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110228
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Insulin Lispro)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Area Under Curve
MH  - Blood Glucose/metabolism
MH  - Cross-Over Studies
MH  - Diabetes Mellitus, Type 1/blood/*drug therapy/*metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/blood/*pharmacokinetics
MH  - Injections, Intradermal
MH  - Injections, Subcutaneous
MH  - Insulin/administration & dosage/*analogs & derivatives/blood/pharmacokinetics
MH  - Insulin Lispro
MH  - Male
MH  - Middle Aged
MH  - Needles
MH  - Postprandial Period
MH  - Young Adult
EDAT- 2011/03/02 06:00
MHDA- 2011/08/04 06:00
CRDT- 2011/03/02 06:00
PHST- 2011/03/02 06:00 [entrez]
PHST- 2011/03/02 06:00 [pubmed]
PHST- 2011/08/04 06:00 [medline]
AID - 10.1089/dia.2010.0183 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2011 Apr;13(4):443-50. doi: 10.1089/dia.2010.0183. Epub 
      2011 Feb 28.