By Lilian Anekwe
A new inhaled insulin drug has shown promising results in patients with diabetes, according to the results of clinical trials.
A randomised controlled trial of an inhaled prandial insulin combined with basal insulin found the new drug treatment regimen is comparable with standard insulin therapy, but may offer a reduced risk of hypoglycaemia and encourage more weight loss.
Previous attempts to bring inhaled insulins to market have not fared well, with Pfizer forced to withdraw its inhaled insulin, Exubera, in November 2007 due to poor global sales.
The latest incarnation, called Afrezza, is being developed by the MannKind corporation, a US-based pharmaceutical company and manufactured for the treatment of adults with either type 1 or type 2 diabetes.
US researchers randomised 334 patients to inhaled insulin up to 90U per meal plus bedtime insulin glargine of between 20 and 56 IU, and 343 patients to a twice-daily premixed insulin regimen of 70% insulin aspart protamine suspension and 30% insulin aspart of rDNA origin. Patients were drawn from 10 countries including the UK and all had an HbA1c between 7 and 11%.
The change in HbA1c after 52 weeks of treatment was similar in the two groups, with a 0.68% reduction seen in the inhaled insulin group compared with a 0.76% reduction in the comparison group.
The proportion of subjects achieving an HbA1c target of 7% or less was not statistically different, at 22% and 27%, respectively.
The lack of statistical significance in the difference between the two groups showed the new drug formulation was non-inferior to conventional insulin therapy, the researchers told delegates at the American Diabetes Association conference in Orlando.
Fasting plasma glucose fell dramatically further in the inhaled insulin plus glargine group. The rate of severe hypoglycaemia was approximately 60% lower in the group on inhaled insulin, with 4% of patients reporting an event compared with 10% in the comparison group.
Weight gain was significantly different. Patients on the 70/30 mix gained around 2.5kg while patients on inhaled insulin gained 0.9kg.
There was an increased occurrence of cough and a change in pulmonary function in patients taking inhaled insulin, which the researchers said was evidence of ‘the slow decline in FEV1 over time in patients with diabetes’.
Dr Daniel Lorber, an endocrinologist at the Diabetes Control Foundation in New York who worked on the study, told delegates: ‘We believe the use of inhaled insulin in combination with basal insulin provides comparable HbA1c control to conventional regimens in patients with type 2 diabetes.’
Inhaled insulin ‘as good as standard therapy’