Conditions: Type 2 Diabetes Mellitus
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 229
Healthy volunteers: no

Brief summary:
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005

Detailed description:
This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo.

Arms:
arm 1: Technosphere® Insulin Inhalation Powder

Interventions: intervention 1: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Intervention descriptions: intervention 1: Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U

Protocol document: