MannKind reports rapid insulin trial success

US drugmaker MannKind has reported preliminary top-line results from two pivotal Phase III studies of Afresa, the company's ultra-rapid acting  insulin product, showing both trials achieved their primary endpoints.

Study 102 compared the efficacy of meal-time Afresa in combination with  a long-acting basal insulin versus twice-daily injections of pre-mixed  insulin in patients with type 2 diabetes. A total of 323 subjects were  randomized to the Afresa group and 331 to the pre-mix group. Over the  52-week period of this study, A1C levels decreased comparably in the two  treatment groups: 0.59 in the Afresa cohort and 0.71 in the pre-mix arm.  The 95% confidence interval (0.29%) of the between-group difference did  not exceed the predetermined threshold of 0.4%, thereby establishing  non-inferiority.

Study 030 compared the pulmonary safety of meal-time inhalation of  Afresa vs usual care. A total of 938 patients with type 1 and type 2  diabetes were randomized to the Afresa group; 951 subjects were  randomized to the comparator cohort. An additional 164 subjects without  diabetes were enrolled into a third arm in order to assess the effect of  diabetes on pulmonary function. The primary endpoint of Study 030 was a  less than 50mL per year decline from baseline measures of FEV1 over the  entire study period. After two years of treatment, the difference  between mean FEV1 values for the two treatment groups was 37mL (95% CI:  14-60mL) - well within the 100mL pre-defined limit. Non-inferior results  were also observed in secondary measures of lung function, including  FVC, TLC and DLCo.