A 2-Month Safety Follow-Up Trial

December 1, 2014 updated by: Mannkind Corporation

A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.

Study Type

Observational

Enrollment (Actual)

649

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- - Sao Paulo, Brazil, 01244-030
    - CPClin-Centro de Pesquisas Clinicas
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Hospital de Clínicas de Porto Alegre
Canada
- Ontario
  - Brampton, Ontario, Canada, L6T 3J1
    - Aggarwal and Associates Ltd
  - London, Ontario, Canada, N6C 5J1
    - Parkwood Hospital
  - Markham, Ontario, Canada, L6C 1Y9
    - Quest Clinical Trials
  - Oakville, Ontario, Canada, L6H 3P1
    - Lifestyle Metabolism Center
  - Sarnia, Ontario, Canada, N7T 4X3
    - The London Road Diagnostic Clinic and Medical Centre
  - Sarnia, Ontario, Canada, N7T 4X3
    - Sarnia Institute of Clinical Research
  - Thornhill, Ontario, Canada, L4J 8L7
    - Lifestyle Metabolism Center
  - Toronto, Ontario, Canada, M4R 2G4
    - Lifestyle Metabolism Center
  - Toronto, Ontario, Canada, M9W 4L6
    - Manna Research
  - Toronto, Ontario, Canada, M4T 1N5
    - Trial Management Group Inc (Henein
Russian Federation
- RUS
  - Kemerovo, RUS, Russian Federation, 650061
    - NHI Kemerovo Regional Clinical Hospital
  - Kemerovo, RUS, Russian Federation, 650061
    - Kemerovo State Medical Academy of Ministry of Health
  - Moscow, RUS, Russian Federation, 105229
    - NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
  - Moscow, RUS, Russian Federation, 111399
    - NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
  - Moscow, RUS, Russian Federation, 115280
    - Moscow City Clinical Hospital # 13
  - Moscow, RUS, Russian Federation, 119435
    - SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
  - Moscow, RUS, Russian Federation, 125299
    - SI Internal Affairs of Moscow- Clinical Hospital
  - Moscow, RUS, Russian Federation, 125315
    - RAAMS Endocrinology and Diabetology Department
  - Moscow, RUS, Russian Federation, 109240
    - Moscow State Medical-Stomatological University City Clinical Hospital # 23
  - Moscow, RUS, Russian Federation, 113093
    - Russian State Medical University City Hospital # 4
  - Moscow, RUS, Russian Federation, 115280
    - SHI of Moscow City Clinical Hospital #13
  - Moscow, RUS, Russian Federation, 117 593
    - NI Central Clinical Hospital of RAS
  - Moscow, RUS, Russian Federation, 117593
    - Russian State Medical University Central Clinical Hospital Russian Science Academy
  - Moscow, RUS, Russian Federation, 119048
    - City Clinical Hospital # 61
  - Moscow, RUS, Russian Federation, 121069
    - Russian Scientific Center of Restoration Medicine & Balneology
  - Moscow, RUS, Russian Federation, 127644
    - SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
  - Ryazan, RUS, Russian Federation, 390026
    - Ryazan State Medical University na academician IP Pavlov
  - Smolensk, RUS, Russian Federation, 214018
    - NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
  - St Petersburg, RUS, Russian Federation, 193012
    - St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
  - St Petersburg, RUS, Russian Federation, 194291
    - Central Medical Sanitary Unit #122
  - St Petersburg, RUS, Russian Federation, 197022
    - Pavlov State Medical Univ of St Petersburg
  - St Petersburg, RUS, Russian Federation, 195257
    - St Petersburg Medical Academy St Elizabeth Hospital
  - St Petersburg, RUS, Russian Federation, 198013
    - TUV Medico-Military Academy
  - St. Petersburg, RUS, Russian Federation, 194354
    - St Petersburg NHI Municipal Multi-Speciality Hospital # 2
  - Yaroslavl, RUS, Russian Federation, 150003
    - MHI Clinical Hospital for Emergency Care na NV Soloviev
  - Yaroslavl, RUS, Russian Federation, 150023
    - MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
  - Yaroslavl, RUS, Russian Federation, 150062
    - NHI Yaroslavl Regional Clinical Hospital
  - Yaroslavl, RUS, Russian Federation, 150003
    - Clinical Pharm Dept of Yaroslavl Clin Hospital
  - Yaroslavl, RUS, Russian Federation, 150062
    - Yaroslavl Regional Clinical Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35215
    - Parkway Medical Center
  - Mobile, Alabama, United States, 36608
    - Coastal Clinical Research Inc
- Arizona
  - Chandler, Arizona, United States, 85225
    - Radiant Research (Phoenix)
  - Phoenix, Arizona, United States, 85029
    - Northwest Medical Center
  - Phoenix, Arizona, United States, 85016
    - Southwest Health Ltd Research Division
  - Tucson, Arizona, United States, 85712
    - Canyon Clinical Research
  - Tuscon, Arizona, United States, 85712
    - Arizona Research Associates
- California
  - Burlingame, California, United States, 94010
    - Private Practice
  - Chula Vista, California, United States, 91911
    - International Clinical Research Network
  - Foothill Ranch, California, United States, 92610
    - Family Medical Center
  - Fresno, California, United States, 93720
    - Saint Agnes Medical Center
  - Fresno, California, United States, 93720
    - Valley Research
  - Fresno, California, United States, 93710
    - Saad Hijazi MD Inc
  - Garden Grove, California, United States, 92840
    - Digestive & Liver Disease Specialist A Medical Group Inc
  - Huntington Beach, California, United States, 92648
    - Diabetes/Lipid Management and Research Center
  - Los Alamitos, California, United States, 90720
    - Interlink Research Institute
  - Pasadena, California, United States, 91105
    - Southern California Endocrine Center
  - San Mateo, California, United States, 94401
    - Dorothy L & James E Frank Diabetes Research Institute
  - Santa Barbara, California, United States, 93105
    - Sansum Medical Research Institute
  - Santa Monica, California, United States, 90404
    - Coastal Biomedical Research Inc
  - Spring Valley, California, United States, 91978
    - Encompass Clinical Research
  - Tustin, California, United States, 92780
    - Diabetes Research Center
- Colorado
  - Denver, Colorado, United States, 80209
    - Creekside Endocrine Associates
- Connecticut
  - Waterbury, Connecticut, United States, 06708
    - Chase Medical Research LLC
- Florida
  - Hollywood, Florida, United States, 33021
    - Center for Diabetes & Endocrine Care
  - Miami, Florida, United States, 33156
    - International Research Associates LLC
  - Miami, Florida, United States, 33136
    - University of Miami Diabetes Research Institute
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Laureate Clinical Research Group
  - Atlanta, Georgia, United States, 30342
    - Executive Health and Research Associates Inc
  - Conyers, Georgia, United States, 30094
    - Rockdale Medical Research Associates
  - Decatur, Georgia, United States, 30035
    - Private Practice
  - Dunwoody, Georgia, United States, 30338
    - Atlanta Pharmaceutical Research Center
  - Lawrenceville, Georgia, United States, 30045
    - North Atlanta Endocrinology & Diabetes PC
  - Roswell, Georgia, United States, 30076
    - Endocrine Research Solutions, Inc.
- Illinois
  - Chicago, Illinois, United States, 60612
    - John H Stoger Jr Hospital of Cook County
  - Chicago, Illinois, United States, 60607
    - Cedar-Crosse Research Center
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Model Clinical Research
  - Baltimore, Maryland, United States, 21237
    - Franklin Square Hospital
  - Baltimore, Maryland, United States, 21209
    - Health Trends Research LLC
  - Towson, Maryland, United States, 21204
    - James A Dicke MDPA
- Michigan
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - St Clair Shores, Michigan, United States, 48081
    - KMED Research
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Radiant Research Inc (Minneapolis)
  - Minneapolis, Minnesota, United States, 55455
    - Center for Urologic Clinical Trials University of Minnesota
- Missouri
  - Florissant, Missouri, United States, 63031
    - HealthCare Research
  - St Louis, Missouri, United States, 63117
    - MedEx Healthcare Research Inc(009)
  - St Louis, Missouri, United States, 63117
    - Clayton Medical Research
  - St Peters, Missouri, United States, 63376
    - Amin Radparvar's Private Practice
  - St. Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St. Louis, Missouri, United States, 63141
    - Mercy Health Research
- Montana
  - Billings, Montana, United States, 59101
    - Deaconess Billings Clinic Research Center
  - Billings, Montana, United States, 59102
    - Montana Health Research Institute
- Nebraska
  - Omaha, Nebraska, United States, 68131
    - Creighton Diabetes Center
- New Jersey
  - Hillsborough, New Jersey, United States, 08844
    - Your Doctors Care
  - Trenton, New Jersey, United States, 08618
    - Hopewell Valley Medical Group
  - Voorhees, New Jersey, United States, 08043
    - Umdnj-Som
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico HCS
  - Albuquerque, New Mexico, United States, 87106
    - New Mexico Clinical Research & Osteoporosis Center
  - Albuquerque, New Mexico, United States, 87108
    - Lovelace Scientific Resources (Albuquerque)
  - Albuquerque, New Mexico, United States, 87109
    - Southwest Endocrinology Associates
- New York
  - Flushing, New York, United States, 11365
    - Diabetes Care & Information Center of New York
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - New Hyde Park, New York, United States, 11042
    - North Shore Diabetes and Endocrine Associates
  - New York, New York, United States, 10023
    - M.E.R.I.
  - Staten Island, New York, United States, 10301
    - Univeristy of Physicians Group Endocrine Division
- North Carolina
  - Charlotte, North Carolina, United States, 28209
    - Metrolina Medical Research
  - Charlotte, North Carolina, United States, 28277
    - Sensenbrenner Primary Care
  - Greenville, North Carolina, United States, 27834
    - Physician's East PA
- Ohio
  - Cleveland, Ohio, United States, 44122
    - Rapid Medical Research Inc
  - Dayton, Ohio, United States, 45439
    - Providence Health Partners - Center of Clinical Research
  - Kettering, Ohio, United States, 45429
    - Wells Institute for Health Awareness
  - Mentor, Ohio, United States, 44060
    - Your Diabetes Endocrine Nutrition Group
- Oregon
  - Portland, Oregon, United States, 97210
    - Portland Diabetes & Endocrinology Center
  - Portland, Oregon, United States, 97232
    - Legacy Clinical Research
  - Portland, Oregon, United States, 97239
    - Covance CRU Inc.
- Pennsylvania
  - Morrisville, Pennsylvania, United States, 19067
    - Bucks County Clinical Research
- South Carolina
  - Greenville, South Carolina, United States, 29615
    - Upstate Pharmaceutical Research
  - Taylors, South Carolina, United States, 29687
    - Southeastern Research Associates Inc
- Tennessee
  - Bartlett, Tennessee, United States, 38133
    - AM Diabetes And Endocrinology Center
  - Collierville, Tennessee, United States, 38017
    - Collierville Medical Specialists
  - Memphis, Tennessee, United States, 38119
    - Memphis Internal Medicine PLLC
- Texas
  - Arlington, Texas, United States, 76014
    - Israel Hartman MD
  - Colleyville, Texas, United States, 76034
    - Texas Familicare Clinical Research
  - Dallas, Texas, United States, 75390
    - University of Texas Southwestern Medical Center
  - Dallas, Texas, United States, 75231
    - Radiant Research Dallas-North
  - Dallas, Texas, United States, 75251
    - Galenos Research
  - Dallas, Texas, United States, 75246
    - Baylor Endocrine Center
  - Dallas, Texas, United States, 75230
    - Dallas Diabetes & Endocrine Center
  - Dallas, Texas, United States, 75231
    - North Texas Endocrine Center
  - Friendswood, Texas, United States, 77546
    - Spuhler Medical Associates
  - Plano, Texas, United States, 75093
    - SMO: Pharmaceuticals C-Trials North Texas Medical Research
  - San Antonio, Texas, United States, 78229
    - Diabetes & Glandular Disease Research Assoc PA
  - San Antonio, Texas, United States, 78229
    - Sam Clinical Research Center
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas Inc
  - San Antonio, Texas, United States, 78205
    - Quality Assurance Research Center Inc
  - San Antonio, Texas, United States, 78229
    - Covenant Clinic Research
  - Temple, Texas, United States, 76508
    - Scott & White Hospital and Clinic
- Utah
  - Bountiful, Utah, United States, 84010
    - Pharmaceutical Research Organization
  - Magna, Utah, United States, 84044
    - Magna Center for Family Medicine
  - Salt Lake City, Utah, United States, 84107
    - Radiant Research Salt Lake City
  - Salt Lake City, Utah, United States, 84107
    - Salt Lake Research
  - West Valley City, Utah, United States, 84120
    - Granger Medical Clinic
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Clinical Research Associates of Tidewater
  - Virginia Beach, Virginia, United States, 23462
    - Sentara Medical Group
- Washington
  - Federal Way, Washington, United States, 98003
    - Larry D Stonesifer MD Inc PS
  - Renton, Washington, United States, 98055
    - Rainier Clinical Research Center Inc
  - Tacoma, Washington, United States, 98405
    - Cedar Research
  - Tacoma, Washington, United States, 98405
    - Liberty Research Center
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Medical Center Clinical Research Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of eligible type 1 and type 2 diabetic subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030).

Description

Inclusion Criteria:

Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030)
Urine cotinine test of less than or equal to 100 ng/mL
Written informed consent

Exclusion Criteria:

Subjects who started smoking during the 4 week follow-up phase of the parent trial
Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial
Female subjects who are pregnant, lactating or planning on becoming pregnant
Subjects with a positive urine drug screening at Visit 1
Female subjects of child-bearing potential not practicing adequate birth control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ex-TI Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder)	Drug: Technosphere Insulin Inhalation Powder Subjects previously treated with Technosphere Insulin Inhalation Powder
Non Ex-TI Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication)	Drug: Comparator Subjects previously treated with other anti-diabetic medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 Time Frame: 9 to 27 months	9 to 27 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 Time Frame: 9 to 27 months	9 to 27 months
Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 Time Frame: 9 to 27 months	9 to 27 months
Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 Time Frame: 9 to 27 months	9 to 27 months
Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 Time Frame: 3 Months	3 Months
Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 Time Frame: 3 Months	3 Months
Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 Time Frame: 3 Months	3 Months
Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 Time Frame: 3 Months	3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mannkind Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

MKC-TI-126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

A 2-Month Safety Follow-Up Trial