Technosphere Insulin Over Other Treatment Regimens

Diabetes and cancer treatments developer MannKind has initiated patient enrollment in two pivotal 12-month phase III clinical trials of its Technosphere Insulin in patients with type 1 and type 2 diabetes.

The main objective of these studies is to evaluate the efficacy of Technosphere Insulin (TI) by assessing changes both in HbA1c levels as well as in blood glucose levels after a standardized meal.

The first of these new trials, Study 009, is a 12-month phase III efficacy study in 500 type 1 patients. In this study, TI will be compared to subcutaneous injections of a rapid-acting insulin analog. Patients in both arms of this study will also receive a basal insulin regimen.

The second of these trials, Study 102, was the subject of a special protocol assessment by the FDA in autumn 2005. This trial will compare TI plus basal insulin to subcutaneous injections of premixed insulin (including a rapid-acting insulin analog) over a 12-month period in 500 type 2 diabetes patients.

With these latest trial initiations, MannKind have begun all but one of their pivotal trials for US approval of Technosphere Insulin, says Alfred Mann, MannKind chairman and CEO.

Filed under Diabetes, Insulin | 1 Comment

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  1. Technosphere Insulin Over Other Treatment Regimens - Consanesco - Health blog Says:

    [...] Read more on The Diabetes Blog [...]

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