Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 353
Healthy volunteers: no

Brief summary:
Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.

Detailed description:

Arms:
arm 1: Technosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs arm 2: Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs

Interventions: intervention 1: Technosphere® Insulin intervention 2: Technosphere Powder
Intervention descriptions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Placebo Comparator

Protocol document: