Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01201928
Recruitment Status : Terminated (Parent trials were either not initiated or terminated)
First Posted : September 15, 2010
Last Update Posted : December 6, 2012
Information provided by (Responsible Party):
Mannkind Corporation

Brief Summary:
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 or disease Intervention/treatment
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: Comparator administered in parent trial Drug: Technosphere Insulin Inhalation Powder

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.

Study Type : Observational
Actual Enrollment : 3 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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)
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

Primary Outcome Measures :
  1. 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). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01201928

United States, California
Valley Research
Fresno, California, United States, 93720
Health Care Partners Medical Group
Long Beach, California, United States, 90806
United States, Georgia
Laureate Clinical Research Group
Atlanta, Georgia, United States, 30308
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
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

Responsible Party: Mannkind Corporation Identifier: NCT01201928     History of Changes
Other Study ID Numbers: MKC-TI-164
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs