MannKind Presents Two Posters At American Diabetes Association's Virtual 81st Scientific Sessions, June 25-29
An insulin regimen that closely mimics physiologic insulin for pediatric patients with type 1 diabetes (T1D) remains a critical goal. Poster 923-P reports on a Phase 2 clinical study to characterize the pharmacokinetics (PK) and safety of prandial Afrezza® (Technosphere® Insulin or TI) in 30 children aged 8 to 17 years with T1D. Afrezza – an ultra rapid-acting dry-powder prandial insulin – is currently indicated to improve glycemic control in adults with T1D or type 2 (T2D) diabetes.
"The final results from the phase 2 pediatric study revealed that serum insulin concentrations peaked rapidly within 10-15 minutes of inhaled administration of TI, similar to the results observed previously in adults. In addition, there were no severe hypoglycemic events or clinically relevant declines in pulmonary function, and no new or unexpected signals with TI," said Dr.
PK measurements were obtained in 30 patients with T1D (median age of 12.7 years). Patients met criteria of using insulin for at least one year, and were on a stable regimen of basal-bolus insulin therapy for six weeks or greater. Insulin PK and blood glucose were assessed following single doses of TI.
Poster 722-P presents a retrospective analysis of data from the Levin study, an investigator-initiated trial sponsored by
- Twenty T2D patients who had never been on mealtime insulin before were started on TI and rapidly titrated during the first week and followed for 12 weeks.
- On average, patients showed an 83.5% increase in daytime time-in-range (70-180 mg/dL).
- The study concluded that TI reduced patients' daytime time spent in hyperglycemia (>250 mg/dl) by 76.4% (p=0.0002) and without a significant increase in daytime time spent in hypoglycemia (<54 mg/dl) (p=0.0938).
"Daytime time-in-range continues to be the most challenging aspect of living with diabetes," said Dr.
Available by prescription, Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit afrezza.com.
AFREZZA and TECHNOSPHERE are registered trademarks of
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