PMID- 22920798
OWN - NLM
STAT- MEDLINE
DCOM- 20130131
LR  - 20211021
IS  - 1932-2968 (Electronic)
IS  - 1932-2968 (Linking)
VI  - 6
IP  - 4
DP  - 2012 Jul 1
TI  - Pharmacokinetics and postprandial glycemic excursions following insulin lispro 
      delivered by intradermal microneedle or subcutaneous infusion.
PG  - 743-54
AB  - BACKGROUND: Intradermal (ID) delivery has been shown to accelerate insulin 
      pharmacokinetics (PK). We compared the PK and pharmacodynamic (PD) effects of 
      insulin lispro administered before two daily standardized solid mixed meals 
      (breakfast and lunch), using microneedle-based ID or traditional subcutaneous 
      (SC) delivery. METHOD: The study included 22 subjects with type 1 diabetes in an 
      eight-arm full crossover block design. One arm established each subject's optimal 
      meal dose. In six additional arms, the optimal, higher, and lower doses (+30%, 
      -30%) were each given ID and SC delivery, in random order. The final arm assessed 
      earlier timing for the ID optimal dose (-12 versus -2 min). The PK/PD data were 
      collected for 6 h following meals. Intravenous basal regular insulin was given 
      throughout, and premeal blood glucose (BG) adjusted to 115 mg/dl. RESULTS: The 
      primary end point, postprandial time in range (70-180 mg/dl), showed no 
      route-based differences with a high level of overall BG control for both SC and 
      ID delivery. Secondary insulin PK end points showed more rapid ID availability 
      versus SC across doses and meals (∆Tmax -16 min, ∆T50rising -7 min, ∆T50falling 
      -30 min, all p < .05). Both intrasubject and intersubject variability for ID Tmax 
      were significantly lower. Intradermal delivery showed modest, statistically 
      significant secondary PD differences across doses and meals, generally within 
      90-120 min postprandially (∆12 mg/dl BG at 90 min, ∆7 mg/dl BGmax, ∆7 mg/dl mean 
      BG 0-2 h, all p < .05). CONCLUSIONS: This study indicates that ID insulin 
      delivery is superior to SC delivery in speed of systemic availability and PK 
      consistency and may improve postprandial glucose control.
CI  - (c) 2012 Diabetes Technology Society.
FAU - McVey, Elaine
AU  - McVey E
AD  - BD Technologies, Research Triangle Park, North Carolina 27709, USA.
FAU - Hirsch, Laurence
AU  - Hirsch L
FAU - Sutter, Diane E
AU  - Sutter DE
FAU - Kapitza, Christoph
AU  - Kapitza C
FAU - Dellweg, Sibylle
AU  - Dellweg S
FAU - Clair, Janina
AU  - Clair J
FAU - Rebrin, Kerstin
AU  - Rebrin K
FAU - Judge, Kevin
AU  - Judge K
FAU - Pettis, Ronald J
AU  - Pettis RJ
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120701
PL  - United States
TA  - J Diabetes Sci Technol
JT  - Journal of diabetes science and technology
JID - 101306166
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin Lispro)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Blood Glucose/drug effects/*metabolism
MH  - Cross-Over Studies
MH  - Diabetes Mellitus, Type 1/*drug therapy/metabolism
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/pharmacokinetics
MH  - Infusions, Subcutaneous
MH  - Injections, Intradermal/instrumentation
MH  - Insulin Lispro/*administration & dosage/*pharmacokinetics
MH  - Male
MH  - Meals
MH  - Middle Aged
MH  - Needles
MH  - Postprandial Period/*drug effects
MH  - Young Adult
PMC - PMC3440143
EDAT- 2012/08/28 06:00
MHDA- 2013/02/01 06:00
PMCR- 2013/07/01
CRDT- 2012/08/28 06:00
PHST- 2012/08/28 06:00 [entrez]
PHST- 2012/08/28 06:00 [pubmed]
PHST- 2013/02/01 06:00 [medline]
PHST- 2013/07/01 00:00 [pmc-release]
AID - dst.6.4.0743 [pii]
AID - 10.1177/193229681200600403 [doi]
PST - epublish
SO  - J Diabetes Sci Technol. 2012 Jul 1;6(4):743-54. doi: 10.1177/193229681200600403.