Over the 52-week period of this study, A1C levels decreased comparably in the two treatment groups. Plus there was less hypoglycemia and weight loss with the inhaled insulin and weight gain with the injectable insulin.
MannKind Corporation released preliminary top-line results from a Phase 3 clinical study of the Technosphere(R) Insulin System in patients with type 1 diabetes (Study 009). This study compared the safety and efficacy of prandial inhalations of Technosphere Insulin (the TI group) versus prandial subcutaneous injections of insulin aspart (the comparator group). Both groups also received daily subcutaneous injections of a basal insulin (insulin glargine).
Dr. Peter Richardson, MannKind’s Chief Scientific Officer, commented, "We are very pleased with the results of this study, the first of our three completed pivotal Phase 3 studies. These observations confirm the results of earlier studies and build on the important differentiating features of this product, including its positive effects on fasting glucose levels. Technosphere Insulin promises to be an important additional option for the treatment of patients with type 1 diabetes. Our next step is to lock the databases for the remaining two pivotal studies, which further examine long-term efficacy and safety in patients with diabetes. We are also continuing our preparations to submit a new drug application by year-end or shortly thereafter."
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 compared to the average gain of 1.4 kg (3.0 pounds) observed in the comparator group. This difference between groups was statistically significant (p=0.02).
At different times during the study (weeks 4, 26 and 52), postprandial blood glucose levels were measured over a six-hour period following the ingestion of a standardized meal. One hour after meal ingestion, patients in the TI group exhibited significantly (p<0.01) lower mean blood glucose levels (167.8 mg/dL; 167.9 mg/dL; and 165.7 mg/dL, respectively for each meal challenge) compared to the mean levels exhibited by the comparator group (210.9 mg/dL; 210.8 mg/dL; and 201.0 mg/dL, respectively). A full analysis of the meal challenge data has not yet been completed.
Fewer patients in the TI group experienced one or more hypoglycemic events (95.2%) compared to the proportion affected in the comparator group (98.9%). This difference in overall hypoglycemia in favor of Technosphere Insulin was statistically significant (odds ratio = 0.222; p<0.02).
Over the entire 52-week treatment period, Technosphere Insulin was generally well tolerated. No pulmonary neoplasms were reported. Consistent with the results from earlier studies of a shorter duration, after 52 weeks of treatment, there were no between-group differences in pulmonary function measures, including FEV1 (forced expiratory volume in one second), FVC (forced vital capacity), DLCO (carbon monoxide diffusing capacity) and TLC (total lung capacity). All safety data will be further analyzed along with data from the recently completed two-year pulmonary safety study.
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