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MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes
Date:9/16/2008

es. We are also continuing our preparations to submit a new drug application by year-end or shortly thereafter."

About Study 009

The primary objective of this trial was to compare the efficacy (as expressed by the change in A1C levels) of the treatment received by the TI group versus the treatment received by the comparator group. A total of 565 patients were studied in sites in the United States, Europe and Latin America. A total of 293 patients received Technosphere Insulin, and 272 patients received insulin aspart.

Over the 52-week period of this study, A1C levels decreased comparably in the two treatment groups, with a between-group difference of -0.24%. The 95% confidence interval (-0.09% to -0.40%) did not exceed the predetermined threshold of 0.40%, thereby establishing non-inferiority between Technosphere Insulin and insulin aspart. There were no interactions associated with the data from different sites or different countries; the statistical analysis was conducted on the entire intention-to-treat (ITT) population.

A comparable percentage of patients reached A1C target levels between the two treatment groups. There were no statistically significant differences in the percentage of patients whose A1C level decreased below 8.0% (50.7% for the TI group; 56.3% for the comparator group); 7.0% (16.3%, TI group; 16.2%, comparator group); and 6.5% (7.4%, TI group; 7.2%, comparator group).

Over the 52-week period of the study, fasting blood glucose (FBG) levels decreased significantly (p<0.01) in the TI group compared to the FBG levels observed in patients using insulin aspart. Among patients using TI, mean FBG decreased by 48.8 mg/dL from 188.6 mg/dL at screening to 139.8 mg/dL at the end of the treatment period, compared to a drop of only 20.2 mg/dL from 180.3 mg/dL to 160.1 mg/dL over the same period in the comparator group.

Patients in the TI group lost an average of 2.0 kg (4.3 pounds) over the 52-week treatment period
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SOURCE MannKind Corporation
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