Trials / Terminated
TerminatedNCT00642616
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
A Phase 3, Open-label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder in Type 1 or Type 2 Diabetic Subjects With Obstructive Pulmonary Disease (Asthma or Chronic Obstructive Pulmonary Disease) Over a 12 Months Treatment Period With a 2 Month Follow-up
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Mannkind Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety
Conditions
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
- Moderate Chronic Obstructive Pulmonary Disease
- Asthma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Technosphere® Insulin | Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents |
| DRUG | Usual Care | Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2008-03-25
- Last updated
- 2017-04-14
- Results posted
- 2016-02-15
Locations
21 sites across 3 countries: United States, Russia, Ukraine
Source: ClinicalTrials.gov record NCT00642616. Inclusion in this directory is not an endorsement.