For patients with type 2 diabetes, inhaled insulin before each meal plus insulin glargine before bedtime is as effective at controlling blood sugar as conventional twice daily premixed biaspart insulin therapy, and leads to less weight gain and less hypoglycaemia. The differing results between the two treatments apply whether or not the patients have had previous oral diabetic drugs such as metformin. The findings are reported in an Article in this week's American Diabetes Association meeting Special Issue of The Lancet, by lead investigator Dr Julio Rosenstock, from the Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA, and colleagues.
Technosphere inhaled insulin is an ultra-rapid preparation delivered intrapulmonary by a small palm size inhaler device. Insulin glargine is a long-acting insulin analogue lasting around 24 hours widely used once daily in type 2 diabetes. Biaspart insulin is a premixed preparation of a short-acting insulin analogue (30%) and the intermediate-acting NPH insulin (70%) that is often used twice daily in type 2 diabetes.
Insulin therapy is often a delayed strategy in patients with type 2 diabetes because it is associated with weight gain, hypoglycaemia (abnormally low blood sugar) and the need for injections. Inhaled insulin may have the potential to overcome those barriers and facilitate initiation and optimisation of insulin treatment.
In this randomised study, adult patients with type 2 diabetes with poor blood sugar control with or without previous oral diabetes drug treatments were enrolled from 10 countries. They were allocated in a 1:1 ratio to receive 1 year's treatment with: pre-meal technosphere inhaled insulin powder plus bedtime insulin glargine; or twice daily premixed biaspart insulin. The primary endpoint was a comparison of change in blood sugar control measured by changes in levels of glycosylated haemoglobin (HbA1c) from baseline to end of 1 year.
334 patients were in the inhaled insulin group and 343 in the biaspart insulin group. 107 patients in the inhaled insulin glargine group and 85 patients on biaspart insulin discontinued the trial. 211 in the inhaled insulin group and 237 on biaspart insulin were included in the final analysis. Changes in HbA1c were similar in the two groups—a decrease of 0.68% in the inhaled insulin group and 0.76% in the biaspart insulin group. Patients in the inhaled insulin group gained a mean 0.9kg each, compared with 2.5kg each in the biaspart insulin group. Patients had fewer mild-to-moderate and severe hypoglycaemic events in the inhaled insulin group than the biaspart insulin group. The safety and tolerability profile was similar for both treatments, apart from increased occurrence of cough and a mild change in lung function in the group receiving inhaled insulin.
The authors conclude: "Our findings show that inhaled insulin plus insulin glargine, alone or in combination with an oral antidiabetes drug such as metformin, is an effective alternative to conventional insulin therapy (biaspart insulin) in uncontrolled type 2 diabetes. We believe that use of Technosphere inhaled insulin…could provide improved blood sugar control with lower weight gain and rates of hypoglycaemia in many individuals with type 2 diabetes."
In an accompanying Comment, Dr Clifford J Bailey, Aston University, Birmingham, UK, and Birmingham Children's Hospital, UK, and Dr Anthony H Barnett, Heart of England NHS Foundation Trust and University of Birmingham, UK, say potential safety concerns on inhaled insulin must await more extensive and longer evaluation.
They conclude: "The opportunity for convenient inhaled bolus insulin, to facilitate complex insulin delivery regimens, will be welcomed by some patients. For now, we say: proceed with caution."
Dr Julio Rosenstock, Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA. T) +1 (972) 566-7799 E) juliorosenstock@dallasdiabetes.com
Professor Bailey is attending ADA meeting, and will be travelling or in USA from Thurs June 24. For interviews, please arrange via Sally Finn T) +44 (0) 121 204 4552 E) finns@aston.ac.uk and Alex Earnshaw T) +44 (0) 121 204 4549 E) a.earnshaw@aston.ac.uk / c.j.bailey@aston.ac.uk
For full Article and Comment, see: http://press.thelancet.com/adainhaled.pdf
Note to editors: *HbA1c is used to indicate the average plasma glucose concentration of the preceding two to three months. In general, the reference range (that found in healthy persons who do not have diabetes), is about 4%—5.9%. Patients with diabetes usually have HbA1c levels above 6.5%.
Journal
The Lancet