title: Technosphere insulin effectively controls postprandial glycemia in patients with type 2 diabetes mellitus.
abstract: BACKGROUND
  This pilot trial was designed to determine if an optimal dose of Technosphere(®) insulin (TI) inhalation powder (MannKind Corp., Valencia, CA) could be used regardless of variation in meal carbohydrate (CHO) content.
  
  
  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.
authors.affiliation: Sansum Diabetes Research Institute, Santa Barbara, California 93105, USA. hzisser@sansum.org
authors.forename: Howard
authors.initials: H
authors.lastname: Zisser
authors.forename: Lois
authors.initials: L
authors.lastname: Jovanovic
authors.forename: Kateryna
authors.initials: K
authors.lastname: Markova
authors.forename: Richard
authors.initials: R
authors.lastname: Petrucci
authors.forename: Anders
authors.initials: A
authors.lastname: Boss
authors.forename: Peter
authors.initials: P
authors.lastname: Richardson
authors.forename: Alfred
authors.initials: A
authors.lastname: Mann
mesh_terms: D000280:Administration, Inhalation; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D016503:Drug Delivery Systems; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D007328:Insulin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D062407:Meals; D008875:Middle Aged; D010865:Pilot Projects; D019518:Postprandial Period / Q000187:drug effects; D011208:Powders / Q000493:pharmacokinetics; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D011208:Powders; C517652:hemoglobin A1c protein, human