Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166
This study has been terminated.
(Parent trials were either not initiated or terminated)
Sponsor:
Mannkind Corporation
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01201928
First received: August 27, 2010
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to evaluate pulmonary function test (PFT) sub-study in interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100 Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent study.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus |
Drug: Comparator administered in parent trial Drug: Technosphere Insulin Inhalation Powder |
Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Phase 3b, Multicenter, Clinical Trial to Evaluate Pulmonary Function in a Subset of Subjects With Type 1 or Type 2 Diabetes |
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:
- Comparison of change from baseline to final treatment visit in pulmonary function (FEV1 FVC, TLC and DLco) between treatment Groups (TI vs comparator arms) using ANCOVA models. [ Time Frame: Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0). ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | October 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Technosphere Insulin Inhalation Powder |
Drug: Technosphere Insulin Inhalation Powder
Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)
|
|
Comparator
Based on parent trial
|
Drug: Comparator administered in parent trial
Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes
|
Detailed Description:
This study is designed to evaluate and compare changes in pulmonary function (FEV1(forced expiratory volume in 1 second) FVC(forced vital capacity), TLC (total lung capacity) and DLco) in subjects enrolled in 1 of 3 parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166). Up to 100 subjects with Type I and Type II diabetes in the TI Inhalation Powder arm, and 100 subjects with Type I and Type II diabetes in the comparator arm will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent trial.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Interested subjects enrolled in one of three parent trials; MKC-TI-161, MKC-TI-162 or MKC-TI-166
Criteria
Inclusion Criteria:
- Enrollment in one of three parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166)
Exclusion Criteria:
- Subjects who are unable to perform PFTs that meet American Thoracic Society/European Respiratory Society (ATS/ERS) quality recommendations for acceptability and repeatability will be excluded from this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201928
Locations
| United States, California | |
| Valley Research | |
| Fresno, California, United States, 93720 | |
| Health Care Partners Medical Group | |
| Long Beach, California, United States, 90806 | |
| United States, Georgia | |
| Atlanta Diabetes Associates | |
| Atlanta, Georgia, United States, 30309 | |
| Laureate Clinical Research Group | |
| Atlanta, Georgia, United States, 30308 | |
| Alta Pharmaceutical Research Center | |
| Dunwoody, Georgia, United States, 30338 | |
| United States, Indiana | |
| LaPorte County Institute for Clinical Research Inc. | |
| Michigan City, Indiana, United States, 46360 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Billings Clinic Research Center | |
| Billings, Montana, United States, 59101 | |
| United States, New York | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| North Shore Diabetes and Endocrine Associates | |
| New Hyde Park, New York, United States, 11042 | |
| United States, North Carolina | |
| Endocrine Research Physicians East PA | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Texas | |
| Israel Hartman MD | |
| Arlington, Texas, United States, 76014 | |
| Dallas Diabetes & Endocrine Center | |
| Dallas, Texas, United States, 75230 | |
| SAM Clinical Research Center | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Mannkind Corporation
More Information
No publications provided
| Responsible Party: | Mannkind Corporation |
| ClinicalTrials.gov Identifier: | NCT01201928 History of Changes |
| Other Study ID Numbers: | MKC-TI-164 |
| Study First Received: | August 27, 2010 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013