PMID- 23046397
OWN - NLM
STAT- MEDLINE
DCOM- 20130402
LR  - 20221207
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 14
IP  - 11
DP  - 2012 Nov
TI  - Technosphere insulin effectively controls postprandial glycemia in patients with 
      type 2 diabetes mellitus.
PG  - 997-1001
LID - 10.1089/dia.2012.0101 [doi]
AB  - BACKGROUND: This pilot trial was designed to determine if an optimal dose of 
      Technosphere((R)) insulin (TI) inhalation powder (MannKind Corp., Valencia, CA) 
      could be used regardless of variation in meal carbohydrate (CHO) content. 
      SUBJECTS AND METHODS: In total, eight subjects (seven men, one woman) with type 2 
      diabetes were enrolled. Subjects underwent dose optimization meal challenge (MC) 
      visits (100% CHO) and MCs with varied CHO meal contents (50%, 200%, and 0% 
      calculated CHOs). Primary end point was change in postprandial glucose (PPG) 
      excursions. Baseline demographics were 60+/-7 years of age, diabetes duration of 
      12.3+/-4.27 years, hemoglobin A1c (A1C) of 7.82+/-1.04%, and body mass index of 
      31.3+/-5.48 kg/m(2). RESULTS: Maximum mean PPG excursions for the nominal 100% CHO 
      meals were -13+/-15 mg/dL for breakfast (B) and -14+/-15 mg/dL for lunch (L), similar 
      to those after 50% CHO meals (B, -17+/-16 mg/dL; L, +14+/-10 mg/dL). The largest 
      excursions occurred during 200% CHO meals and remained below American Diabetes 
      Association targets (B, +19+/-16 mg/dL; L, +32+/-29 mg/dL). During 15 of the MCs, 
      subjects took their usual TI dose and then had no meal (0% CHO). For the 0% CHO 
      MCs, the largest mean PPG excursion were -33+/-9 mg/dL at 60 min (B) and 
      -31+/-10 mg/dL at 60 and 90 min (L). Mean A1C dropped from 7.82+/-1.04% at the Week 1 
      visit to 6.18+/-0.46% (P=0.00091) at the Week 19 visit. CONCLUSIONS: Results in 
      eight patients suggest that once an optimal dose of TI is determined, type 2 
      diabetes patients can ingest meals with a wide range of CHO content or even skip 
      meals without severe hypoglycemia. During this pilot study TI therapy improved 
      A1C by -1.63% (P=0.00091) during 19 weeks of treatment.
FAU - Zisser, Howard
AU  - Zisser H
AD  - Sansum Diabetes Research Institute, Santa Barbara, California 93105, USA. 
      hzisser@sansum.org
FAU - Jovanovic, Lois
AU  - Jovanovic L
FAU - Markova, Kateryna
AU  - Markova K
FAU - Petrucci, Richard
AU  - Petrucci R
FAU - Boss, Anders
AU  - Boss A
FAU - Richardson, Peter
AU  - Richardson P
FAU - Mann, Alfred
AU  - Mann A
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20121009
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Powders)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Administration, Inhalation
MH  - Blood Glucose/*drug effects/metabolism
MH  - Body Mass Index
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - *Drug Delivery Systems
MH  - Female
MH  - Glycated Hemoglobin/*drug effects/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/*pharmacokinetics
MH  - Insulin/administration & dosage/*pharmacokinetics
MH  - Male
MH  - Meals
MH  - Middle Aged
MH  - Pilot Projects
MH  - Postprandial Period/drug effects
MH  - Powders/pharmacokinetics
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2012/10/11 06:00
MHDA- 2013/04/03 06:00
CRDT- 2012/10/11 06:00
PHST- 2012/10/11 06:00 [entrez]
PHST- 2012/10/11 06:00 [pubmed]
PHST- 2013/04/03 06:00 [medline]
AID - 10.1089/dia.2012.0101 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2012 Nov;14(11):997-1001. doi: 10.1089/dia.2012.0101. Epub 
      2012 Oct 9.