Technosphere insulin effectively controls postprandial glycemia in patients with type 2 diabetes mellitus

Diabetes Technol Ther. 2012 Nov;14(11):997-1001. doi: 10.1089/dia.2012.0101. Epub 2012 Oct 9.

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.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Blood Glucose / drug effects*
  • Blood Glucose / metabolism
  • Body Mass Index
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Dose-Response Relationship, Drug
  • Drug Delivery Systems*
  • Female
  • Glycated Hemoglobin A / drug effects*
  • Glycated Hemoglobin A / metabolism
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / pharmacokinetics*
  • Insulin / administration & dosage
  • Insulin / pharmacokinetics*
  • Male
  • Meals
  • Middle Aged
  • Pilot Projects
  • Postprandial Period / drug effects
  • Powders / pharmacokinetics
  • Time Factors
  • Treatment Outcome

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • Powders
  • hemoglobin A1c protein, human