|Aradigm Announces Novo Nordisk Presentation of Data of AERx Insulin Diabetes Management System at the American Diabetes Association Annual Meeting|
Tuesday June 14, 4:00 pm ET
HAYWARD, Calif., June 14 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News) announced that at a session today at the Annual Meeting of the American Diabetes Association (ADA) its partner, Novo Nordisk, gave an oral presentation of clinical data from a recent pharmacokinetic/pharmacodynamic trial of the AERx insulin Diabetes Management System. Novo Nordisk previously discussed results from this trial during their first quarter financial conference call on April 28, 2005. The presentation is entitled "Onset of Action of Inhaled Insulin Via the AERx® iDMS Was Faster Than Subcutaneous Human Regular Insulin and Similar to That of Subcutaneous Insulin Aspart" and summarizes the findings from the trial. The abstract is available below and at the ADA website www.diabetes.org.
The purpose of this single-center, open-labeled, three-period cross-over trial was to compare the onset of action and duration of action of inhaled insulin via the AERx® insulin Diabetes Management System (iDMS) to that of subcutaneously (s.c.) administered insulin aspart and s.c. human regular insulin.
In total, 15 non-smoking people with type1 diabetes (34 +/- 10 years (meanSD), BMI 24.3 +/- 2.3 kg/m2, duration of diabetes 7.5 +/- 0.9 years) were randomized to receive a dose (0.3 AERx U/kg, U/kg or IU/kg) of inhaled insulin via the AERx® iDMS (AERx), insulin aspart s.c.(IAsp) and human regular insulin s.c. (HI) on three different dosing days in randomized order. The study was carried out by means of 10 hour isoglycemic glucose clamp (clamp level of 7.2mM) and the glucose infusion rate (GIR) recorded for 10-hours post dosing.
The onset of action (defined as time to 10% of AUC GIR(0-10h)) was faster for AERx (72 [62;82] min (LSMeans [95%CI])) compared to HI (89 [79;100] min, P=0.01), and not different from IAsp (66 [56;76] min, NS). Duration of action (defined as time interval from t 10%AUCGIR(0-10h) to t 90%AUCGIR(0-10h)) for AERx was longer (291 [264;318] min) than IAsp (209 [182;235] min, P<0.01), but not different to that of HI (297 [270;323] min, NS). The time to maximum GIR (t GIRmax) did not differ between AERx (142 [106;178] min) and IAsp (136 [101;171] min, NS), while t GIRmax for AERx was faster than HI (202 [167;237] min, P=0.01). No safety issues were raised in this trial; adverse events were few and mild.
In conclusion, inhaled insulin via the AERx® iDMS has an onset of action not significantly different to subcutaneous insulin aspart, but significantly faster than human regular insulin, while the duration of action is not significantly different to human regular insulin, but significantly longer than insulin aspart. These characteristics make inhaled insulin via the AERx® iDMS suitable as a meal-time insulin.