Titration of inhaled human insulin (Exubera) in a treat-to-target regimen for patients with type 2 diabetes.
OBJECTIVE
This study assessed the feasibility of safely achieving target glycated hemoglobin (A1C) of < or =7% by intensifying structured insulin titration regimens using inhaled human insulin (Exubera [EXU] [Pfizer Inc., New York, NY] [insulin human (recombinant DNA origin)] inhalation powder) in patients with type 2 diabetes inadequately controlled on combination oral antidiabetes agents (OADs).


METHODS
In a randomized, open-label, parallel, 24-week multicenter trial, 107 type 2 diabetes patients with mean baseline A1C of 8.6% taking two or more OADs were randomized to adjust EXU before meals following either weekly office visits or more intense twice-weekly telephone/office consultations, using a simple but structured insulin titration algorithm seeking to attain specific premeal glucose levels. Primary outcome was the percentage of patients reaching A1C < or =7%; secondary measures were changes in A1C, eight-point self-monitored blood glucose values, postprandial glucose levels during a meal tolerance, and frequency of hypoglycemia.


RESULTS
A1C improved whether EXU was systematically titrated once (6.8%) or twice weekly (6.8%), and two-thirds of patients in both groups attained A1C < or =7% (69% and 67%, respectively). Relative to baseline, glucose profiles were reduced at all time points measured, and postprandial glucose levels during meal tolerance improved to a similar extent in both groups. There were 538 hypoglycemic events with twice-weekly and 343 with once-weekly EXU titration; other adverse events were similar between groups.


CONCLUSIONS
Added to oral therapy, premeal inhaled insulin can safely achieve < or =7% A1C in most patients with type 2 diabetes inadequately controlled while taking two or more OADs if a once- or twice-weekly structured insulin titration regimen is used.
Hollander
Priscilla A
PA
Baylor University Medical Center, Dallas, Texas 75246, USA. priscilh@BaylorHealth.edu
Cefalu
William T
WT
Mitnick
Michael
M
Lawrence
David
D
Rosenstock
Julio
J
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000187:drug effects; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D012648:Self Care / Q000379:methods; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin; D008687:Metformin; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C473734:Exubera; C517652:hemoglobin A1c protein, human