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Drug Evaluations

Technosphere insulin: inhaled prandial insulin

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Bibliography

••Pivotal phase III trial in T1DM conducted by the Affinity 1 Study Group.

  • Rosenstock J, Franco D, Korpachev V, et al. Inhaled technosphere insulin versus inhaled technosphere placebo in insulin-naïve subjects with type 2 diabetes inadequately contolled on oral antidiabetes agents. Diabetes Care. 2015;38:2274–2281.

••Pivotal phase III trial in T2DM conducted by the Affinity 2 Study Group

  • Rosenstock J, Bergenstal R, DeFronzo AR, et al. Efficacy and safety of technosphere inhaled insulin compared with technosphere powder placebo in insulin-naïve type 2 diabetes suboptimally controlled with oral agents. Diabetes Care. 2008;31:2177–2182.

•Important phase II trial.

  • Tack CJ, Vladimir C, De Galan BE, et al. Randomized forced titration to different doses of Technosphere insulin demonstrates reduction in postprandial glucose excursions and hemoglobin A1c in patients with type 2 diabetes. J Diabetes Sci Technol. 2008;2:47–57.

•Important phase II trial.

  • Kapsner P, Bergenstal RM, Rendell M, et al. Comparative efficacy and safety of technosphere insulin and a rapid-acting analog both given with glargine in subjects with T1DM in a 52-week study. Diabetologia. 2009;52(Suppl 1):S386.

••Abstract from pivotal phase III trial in T1DM

  • Rosenstock J, Lorber DL, Gnudi L, et al. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicenter randomized trial. Lancet. 2010;375:2244–2253.

••Pivotal phase III trial in T2DM

  • Raskin P, Heller S, Honka M, et al. Pulmonary function over two years in diabetic patients treated with prandial inhaled Technosphere Insulin or usual antidiabetes treatment: a randomized trial. Diabetes Obesity Metab. 2012;14:163–173.
  • Peyrot M, Rubin RR. Effect of Technosphere inhaled insulin on quality of life and treatment satisfaction. Diabetes Technol Ther. 2010;12:49–55.
  • Peyrot M, Rubin RR. Patient-reported outcomes in adults with type 2 diabetes using mealtime inhaled Technosphere insulin and basal insulin versus premixed insulin. Diabetes Technol Ther. 2011;13:1201–1206.
  • Ahren B, Holst JJ. The cephalic insulin response to meal ingestion in humans is dependent on both cholinergic and noncholinergic mechanisms and is important for postprandial glycemia. Diabetes. 2001;50:1030–1038.
  • Zisser H, Dassau E, Lee JL, et al Clinical results of an automated artificial pancreas using technosphere inhaled insulin to mimic first-phase insulin secretion. J Diabetes Sci Technol. 2015;9:564–572.

•Intriguing small trial investigating innovative ways to improve diabetes control

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