From EASD earlier this month:
>>Inhaled human insulin via the AERx® insulin Diabetes Management System in combination with NPH insulin offers the same metabolic control as intensive s.c. therapy. A proof of concept trial in type 2 diabetic patients.
U. Adamson1, T. Rönnemaa2, A. H. Petersen3, K. Hermansen4;
1Danderyds Sjukhus, Stockholm, Sweden, 2Turku University Hospital, Turku, Finland, 3Novo Nordisk A/S, Bagsvaerd, 4Aarhus Amtssygehus, Aarhus University Hospital, Aarhus, Denmark.
Background and Aims: New modes of insulin treatment are being developed as alternative to injections in order to obtain more physiological insulin levels and to increase compliance. Among those is the AERx® insulin Diabetes Management System (iDMS) for pulmonary administration of insulin. The AERx®iDMS provides flexible insulin dosing, similar to injections, such that 1 AERx® unit delivered by inhalation corresponds approximately to the effect of 1 IU insulin given s.c. This Proof of Concept trial in type 2 diabetic patients was performed to compare the glycaemic control of pre-prandial pulmonary human insulin given via the AERx® iDMS to pre-prandial s.c. injection of human insulin, both in combination with NPH insulin at bedtime.
Materials and Methods: Non-smoking patients of both sexes with type 2 diabetes on any insulin treatment were included in this multi-centre, randomized, parallel, open-labelled, 12-week trial. They were randomised to receive inhaled insulin via the AERx® iDMS immediately before meals, or s.c. injections of human insulin 30 min. before meals. Both groups received NPH insulin at bedtime. A total of 107 patients (67 males and 40 females) were exposed to trial drug and 98 patients (49 in each group) completed the trial. The AERx and s.c. groups were similar with respect to demographic and baseline characteristics, with mean age 59 years, BMI 27.7 kg/m2, fasting serum glucose 11.6 mmol/L (11.4 mmol/L vs. 11.7 mmol/L) and HbA1c 8.5% (8.6% vs. 8.5%), both AERx vs. s.c.
Results: A similar decrease in HbA1c from baseline to end of trial was seen for the AERx and the s.c. groups (0.72% vs. 0.75%, p= 0.90), while decrease in fasting serum glucose was significantly larger in the AERx group (3.00 vs.0.73 mmol/L, p=0.03) with similar bedtime NPH dose in the two groups (0.27IU/kg vs. 0.25 IU/kg, p= 0.95). Comparing the AERx and s.c. groups, the intrasubject variability of fasting blood glucose was similar (30% vs. 27%, p=0.34), as was the intrasubject variability of prandial blood glucose increments (26% vs. 26%, p=0.91). Also there was no statistically significant difference between the absolute prandial blood glucose increments (1.99 vs. 1.33 mmol/L, p= 0.14). The total number of hypoglycaemic events was 151 in the AERx group and 211 in the s.c. group (N.S.). The frequency, nature and severity of adverse events (AEs) were comparable for the two groups. Most frequent AEs in both groups were headache, respiratory tract infection and diarrhoea. No clinically relevant changes were seen in mean pulmonary function tests or chest X-rays in the AERx group. Median total insulin antibody level increased in the AERx group and was unchanged in the s.c. group. No clinical signs or symptoms were reported in connection with the changes in antibodies.
Conclusion: This trial shows that pulmonary insulin administered via the AERx® iDMS immediately before meals in combination with NPH is as efficacious as s.c. human insulin 30 min. before meals in combination with NPH in controlling HbA1c in insulin treated type 2 diabetic patients. No major pulmonary safety issues were seen in this trial.<<
Cheers, Tuck |
