Insulin inhaled(CoreMed Corp.)

OBJECTIVE—We sought to compare and evaluate the impact of inhaled versus injected insulin on potential mediators of patient acceptance of insulin therapy while maintaining comparable A1C levels.RESEARCH DESIGN AND METHODS—During a noninferiority efficacy trial conducted in 40 centers in the U.S., we surveyed treatment satisfaction, quality of life, and adherence barriers at weeks −4, −1, 6, 12, 20, and 24 in adolescents aged 12–17 years and adults with type 1 diabetes who received premeal regular plus twice-daily NPH insulin during a 4-week run-in; then, subjects were randomized to premeal inhaled human insulin plus twice-daily NPH (adults, n = 102; adolescents, n = 60) (inhaled) or remaining on run-in therapy (n = 105 and 60, respectively) (subcutaneous injection).RESULTS—Overall treatment satisfaction (0–100) increased by 13.2 ± 1.1 units for inhaled insulin (baseline = 63.3 ± 1.2) compared with 1.7 ± 0.8 for subcutaneous insulin injection (baseline = 64.1 ± 1.2, P < 0.0001). All 12 satisfaction subscales favored inhaled insulin (all P < 0.01), and effects did not vary by age or sex. Despite similar baseline-adjusted end point A1C for inhaled (7.7 ± 0.1%) and subcutaneous (7.9 ± 0.1%) regimens, quality-of-life scales of mental health, symptoms, health status, cognitive functioning, and adherence barriers during treatment were more favorable for inhaled insulin (all P < 0.05). Greater satisfaction was associated with fewer barriers to insulin adherence (rho = −0.78, P < 0.0001) and a greater reduction in A1C (rho = −0.18, P < 0.001).CONCLUSIONS—Treatment satisfaction was substantially more favorable, adherence barriers moderately lower, and quality of life moderately higher for inhaled compared with subcutaneous regimen. It remains to be demonstrated whether these patient-reported outcomes will translate into improved adherence and glycemic control.

There is a Type 2 diabetes epidemic; however, unfortunately, even though insulin is an effective therapy, it is mostly used late and as a last resort. Type 1 diabetics find it difficult to administer extra insulin injections when needed owing to the inconvenience and, although most cope well, many dislike injecting themselves so frequently. The newly approved EXUBERA^® inhaled insulin should help counteract the resistance of patients and physicians in instituting insulin in the Type 2 diabetic, and the Type 1 diabetic can take more than 1000 fewer injections per year, making their diabetes easier to live with. Pulmonary function tests have demonstrated clinically insignificant changes after years of monitoring. The increases of insulin antibodies found in those who use inhaled insulin have not affected diabetes control. Side effects of inhaled insulin are insignificantly different from injectable insulin except for a couple of mild coughs after an inhalation, which decrease quickly with time. The two dosage forms of EXUBERA insulin are 1 and 3 mg (equivalent to approximately 3 and 8 U of U-100 insulin, respectively), are adaptable to most regimens for both types of diabetes, and inhaled insulin is preferred by a significant majority of patients. Inhaled insulin should be cost effective if it allows earlier institution in the Type 2 diabetic thus improving diabetic control and lowering the expensive complications of diabetes.