A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled
      visits. The visits comprised an initial screening visit, 3 treatment visits for the meal
      challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3
      sequential visits for the glucose clamp, and a final close-out visit.

      Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for
      each completed subject. The visits comprise an initial screening visit, 2 treatment visits
      for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety
      visit, 2 sequential visits for the glucose clamp, and a final close-out visit.

      For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the
      clinical unit for all procedures.
    

Detailed description: 
      The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled
      visits. The visits comprised an initial screening visit, 3 treatment visits for the meal
      challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3
      sequential visits for the glucose clamp, and a final close-out visit.

      After review of the meal challenge data from the Original Protocol design, it became apparent
      that the TI Inhalation Powder, insulin lispro, and Exubera doses were not well matched, and
      resulted in significantly higher insulin exposure following insulin lispro than the two
      inhaled treatments. All meal challenge visits were completed for the 18 subjects enrolled.
      However, the glucose clamp visits were discontinued since it was discovered that a direct
      comparison between the treatments was not possible.

      The protocol was amended (Amendment 1) to ensure that the insulin exposures between TI
      Inhalation Powder and insulin lispro were more suited (increased the TI Inhalation Powder
      doses and decreased the insulin lispro dose). An Exubera arm was not included in Amendment 1
      due to the market removal of this product.

      Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for
      each completed subject. The visits comprise an initial screening visit, 2 treatment visits
      for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety
      visit, 2 sequential visits for the glucose clamp, and a final close-out visit.

      For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the
      clinical unit for all procedures.
    

Intervention name(s): Technosphere Insulin
Intervention type(s): Drug
Intervention description(s): Inhalation 15U/30U
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inhaled Insulin