Trial record 3 of 3099 for:
Open Studies | "Lung Diseases"
Evaluate Safety of T/I on Diabetic Subjects With Mild Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified May 2013 by Mannkind Corporation
Sponsor:
Mannkind Corporation
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00642616
First received: March 21, 2008
Last updated: May 24, 2013
Last verified: May 2013
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Purpose
Examine the effects of T/I in combination with an anti-diabetic regimen of insulin vs. anti-diabetic treatment on lung function & pulmonary safety
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Type 1 With Obstructive Pulmonary Disease Diabetic Type 2 With Obstructive Pulmonary Disease Asthma COPD Type 1 Diabetes Type 2 Diabetes Indeterminate Obstructive Lung Disease |
Drug: Technosphere Insulin Drug: Usual Care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 [COPD]) Over a 12-Month Treatment Period With a 2-Month Follow-up |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin human
U.S. FDA Resources
Further study details as provided by Mannkind Corporation:
Primary Outcome Measures:
- Effects of prandially inhaled TI Inhalation Powder in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents versus antidiabetic treatment without TI Inhalation Powder on lung function & pulmonary safety [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Compare between the treatment groups the effect of treatment on frequency of asthma and COPD exacerbations [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 510 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: T/I Inhalation Powder
Technosphere® Insulin Inhalation Powder
|
Drug: Technosphere Insulin |
|
Active Comparator: UC
Usual anti diabetic care
|
Drug: Usual Care |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of Type1or2 diabetes for 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening
- BMI of 35 kg/m2. A1C 7.0% - 11.0%
- Non-smoker & urine cotinin level <100ng/dL
- Clinical diagnosis of obstructive lung disease
Exclusion Criteria:
- History of pulmonary exacerbation with 8 wks of screening/V1
- Post-brochhodilator FEV1 <50%, FVC <70% NHANES III predicted, peformed at the clinical site using office spirometry
- History of systemic corticosteriod or antibiotic use of respiratory illness within 8 weeks of V1
- Treatment with >4 puffs or >2 nebulizer treatments.day of inhaled short-acting beta agonist or shorty-acting anti-cholingeric agents of a combination of the 2.
- Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs.
- Greater than 2 hospitalizations or ER visits or required >3 courses of systemic steriod in the past 12 mos. for respiratory illness
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642616
Show 74 Study Locations
Contacts
| Contact: MannKind Investigational Site | 6617755300 |
Show 74 Study LocationsSponsors and Collaborators
Mannkind Corporation
Investigators
| Study Chair: | Chief Medical Officer | Mannkind Corporation |
More Information
No publications provided
| Responsible Party: | Mannkind Corporation |
| ClinicalTrials.gov Identifier: | NCT00642616 History of Changes |
| Other Study ID Numbers: | MKC-TI-134 |
| Study First Received: | March 21, 2008 |
| Last Updated: | May 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Asthma Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Respiration Disorders Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013