A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period

Trial Profile

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2016

At a glance

  • Drugs Insulin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms Affinity-2
  • Sponsors MannKind Corporation
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 07 Aug 2015 Results published in the Diabetes Care.
    • 14 Aug 2013 The positive results of this study and Study 171 will form the basis of an amendment to an NDA for AFREZZA, which MannKind expects to submit to the US FDA in Q4 2013, according to a media release.
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