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:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014