A 2-Month Safety Follow-Up Trial

NCT ID: NCT00741429

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

649 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ex-TI

Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder)

Technosphere Insulin Inhalation Powder

Intervention Type DRUG

Subjects previously treated with Technosphere Insulin Inhalation Powder

Non Ex-TI

Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication)

Comparator

Intervention Type DRUG

Subjects previously treated with other anti-diabetic medications

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Technosphere Insulin Inhalation Powder

Subjects previously treated with Technosphere Insulin Inhalation Powder

Intervention Type DRUG

Comparator

Subjects previously treated with other anti-diabetic medications

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mannkind Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Parkway Medical Center

Birmingham, Alabama, United States

Site Status

Coastal Clinical Research Inc

Mobile, Alabama, United States

Site Status

Radiant Research (Phoenix)

Chandler, Arizona, United States

Site Status

Southwest Health Ltd Research Division

Phoenix, Arizona, United States

Site Status

Northwest Medical Center

Phoenix, Arizona, United States

Site Status

Canyon Clinical Research

Tucson, Arizona, United States

Site Status

Arizona Research Associates

Tuscon, Arizona, United States

Site Status

Private Practice

Burlingame, California, United States

Site Status

International Clinical Research Network

Chula Vista, California, United States

Site Status

Family Medical Center

Foothill Ranch, California, United States

Site Status

Saad Hijazi MD Inc

Fresno, California, United States

Site Status

Saint Agnes Medical Center

Fresno, California, United States

Site Status

Valley Research

Fresno, California, United States

Site Status

Digestive & Liver Disease Specialist A Medical Group Inc

Garden Grove, California, United States

Site Status

Diabetes/Lipid Management and Research Center

Huntington Beach, California, United States

Site Status

Interlink Research Institute

Los Alamitos, California, United States

Site Status

Southern California Endocrine Center

Pasadena, California, United States

Site Status

Dorothy L & James E Frank Diabetes Research Institute

San Mateo, California, United States

Site Status

Sansum Medical Research Institute

Santa Barbara, California, United States

Site Status

Coastal Biomedical Research Inc

Santa Monica, California, United States

Site Status

Encompass Clinical Research

Spring Valley, California, United States

Site Status

Diabetes Research Center

Tustin, California, United States

Site Status

Creekside Endocrine Associates

Denver, Colorado, United States

Site Status

Chase Medical Research LLC

Waterbury, Connecticut, United States

Site Status

Center for Diabetes & Endocrine Care

Hollywood, Florida, United States

Site Status

University of Miami Diabetes Research Institute

Miami, Florida, United States

Site Status

International Research Associates LLC

Miami, Florida, United States

Site Status

Laureate Clinical Research Group

Atlanta, Georgia, United States

Site Status

Executive Health and Research Associates Inc

Atlanta, Georgia, United States

Site Status

Rockdale Medical Research Associates

Conyers, Georgia, United States

Site Status

Private Practice

Decatur, Georgia, United States

Site Status

Atlanta Pharmaceutical Research Center

Dunwoody, Georgia, United States

Site Status

North Atlanta Endocrinology & Diabetes PC

Lawrenceville, Georgia, United States

Site Status

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States

Site Status

Cedar-Crosse Research Center

Chicago, Illinois, United States

Site Status

John H Stoger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

MODEL Clinical Research

Baltimore, Maryland, United States

Site Status

Health Trends Research LLC

Baltimore, Maryland, United States

Site Status

Franklin Square Hospital

Baltimore, Maryland, United States

Site Status

James A Dicke MDPA

Towson, Maryland, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

KMED Research

Saint Clair Shores, Michigan, United States

Site Status

Radiant Research Inc (Minneapolis)

Edina, Minnesota, United States

Site Status

Center for Urologic Clinical Trials University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Amin Radparvar's Private Practice

City of Saint Peters, Missouri, United States

Site Status

Healthcare Research

Florissant, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Clayton Medical Research

St Louis, Missouri, United States

Site Status

MedEx Healthcare Research Inc(009)

St Louis, Missouri, United States

Site Status

Mercy Health Research

St Louis, Missouri, United States

Site Status

Deaconess Billings Clinic Research Center

Billings, Montana, United States

Site Status

Montana Health Research Institute

Billings, Montana, United States

Site Status

Creighton Diabetes Center

Omaha, Nebraska, United States

Site Status

Your Doctors Care

Hillsborough, New Jersey, United States

Site Status

Hopewell Valley Medical Group

Trenton, New Jersey, United States

Site Status

Umdnj-Som

Voorhees Township, New Jersey, United States

Site Status

New Mexico Clinical Research & Osteoporosis Center

Albuquerque, New Mexico, United States

Site Status

Lovelace Scientific Resources (Albuquerque)

Albuquerque, New Mexico, United States

Site Status

Southwest Endocrinology Associates

Albuquerque, New Mexico, United States

Site Status

University of New Mexico HCS

Albuquerque, New Mexico, United States

Site Status

Diabetes Care & Information Center of New York

Flushing, New York, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, United States

Site Status

M.E.R.I.

New York, New York, United States

Site Status

Univeristy of Physicians Group Endocrine Division

Staten Island, New York, United States

Site Status

Metrolina Medical Research

Charlotte, North Carolina, United States

Site Status

Sensenbrenner Primary Care

Charlotte, North Carolina, United States

Site Status

Physician's East PA

Greenville, North Carolina, United States

Site Status

Rapid Medical Research Inc

Cleveland, Ohio, United States

Site Status

Providence Health Partners - Center of Clinical Research

Dayton, Ohio, United States

Site Status

Wells Institute for Health Awareness

Kettering, Ohio, United States

Site Status

Your Diabetes Endocrine Nutrition Group

Mentor, Ohio, United States

Site Status

Portland Diabetes & Endocrinology Center

Portland, Oregon, United States

Site Status

Legacy Clinical Research

Portland, Oregon, United States

Site Status

Covance CRU Inc.

Portland, Oregon, United States

Site Status

Bucks County Clinical Research

Morrisville, Pennsylvania, United States

Site Status

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Site Status

Southeastern Research Associates Inc

Taylors, South Carolina, United States

Site Status

AM Diabetes and Endocrinology Center

Bartlett, Tennessee, United States

Site Status

Collierville Medical Specialists

Collierville, Tennessee, United States

Site Status

Memphis Internal Medicine PLLC

Memphis, Tennessee, United States

Site Status

Israel Hartman MD

Arlington, Texas, United States

Site Status

Texas Familicare Clinical Research

Colleyville, Texas, United States

Site Status

Dallas Diabetes & Endocrine Center

Dallas, Texas, United States

Site Status

North Texas Endocrine Center

Dallas, Texas, United States

Site Status

Radiant Research Dallas-North

Dallas, Texas, United States

Site Status

Baylor Endocrine Center

Dallas, Texas, United States

Site Status

Galenos Research

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Spuhler Medical Associates

Friendswood, Texas, United States

Site Status

SMO: Pharmaceuticals C-Trials North Texas Medical Research

Plano, Texas, United States

Site Status

Quality Assurance Research Center Inc

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas Inc

San Antonio, Texas, United States

Site Status

Covenant Clinic Research

San Antonio, Texas, United States

Site Status

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, United States

Site Status

SAM Clinical Research Center

San Antonio, Texas, United States

Site Status

Scott & White Hospital and Clinic

Temple, Texas, United States

Site Status

Pharmaceutical Research Organization

Bountiful, Utah, United States

Site Status

Magna Center for Family Medicine

Magna, Utah, United States

Site Status

Radiant Research Salt Lake City

Salt Lake City, Utah, United States

Site Status

Salt Lake Research

Salt Lake City, Utah, United States

Site Status

Granger Medical Clinic

West Valley City, Utah, United States

Site Status

Clinical Research Associates of Tidewater

Norfolk, Virginia, United States

Site Status

Sentara Medical Group

Virginia Beach, Virginia, United States

Site Status

Larry D Stonesifer MD Inc PS

Federal Way, Washington, United States

Site Status

Rainier Clinical Research Center Inc

Renton, Washington, United States

Site Status

Cedar Research

Tacoma, Washington, United States

Site Status

Liberty Research Center

Tacoma, Washington, United States

Site Status

Wenatchee Valley Medical Center Clinical Research Department

Wenatchee, Washington, United States

Site Status

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

CPClin-Centro de Pesquisas Clinicas

São Paulo, São Paulo, Brazil

Site Status

Aggarwal and Associates Ltd

Brampton, Ontario, Canada

Site Status

Parkwood Hospital

London, Ontario, Canada

Site Status

Quest Clinical Trials

Markham, Ontario, Canada

Site Status

Lifestyle Metabolism Center

Oakville, Ontario, Canada

Site Status

Sarnia Institute of Clinical Research

Sarnia, Ontario, Canada

Site Status

The London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Site Status

Lifestyle Metabolism Center

Thornhill, Ontario, Canada

Site Status

Lifestyle Metabolism Center

Toronto, Ontario, Canada

Site Status

Trial Management Group Inc (Henein

Toronto, Ontario, Canada

Site Status

Manna Research

Toronto, Ontario, Canada

Site Status

Kemerovo State Medical Academy of Ministry of Health

Kemerovo, RUS, Russia

Site Status

NHI Kemerovo Regional Clinical Hospital

Kemerovo, RUS, Russia

Site Status

NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense

Moscow, RUS, Russia

Site Status

Moscow State Medical-Stomatological University City Clinical Hospital # 23

Moscow, RUS, Russia

Site Status

NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70

Moscow, RUS, Russia

Site Status

Russian State Medical University City Hospital # 4

Moscow, RUS, Russia

Site Status

Moscow City Clinical Hospital # 13

Moscow, RUS, Russia

Site Status

SHI of Moscow City Clinical Hospital #13

Moscow, RUS, Russia

Site Status

NI Central Clinical Hospital of RAS

Moscow, RUS, Russia

Site Status

Russian State Medical University Central Clinical Hospital Russian Science Academy

Moscow, RUS, Russia

Site Status

City Clinical Hospital # 61

Moscow, RUS, Russia

Site Status

SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology

Moscow, RUS, Russia

Site Status

Russian Scientific Center of Restoration Medicine & Balneology

Moscow, RUS, Russia

Site Status

SI Internal Affairs of Moscow- Clinical Hospital

Moscow, RUS, Russia

Site Status

RAAMS Endocrinology and Diabetology Department

Moscow, RUS, Russia

Site Status

SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology

Moscow, RUS, Russia

Site Status

Ryazan State Medical University na academician IP Pavlov

Ryazan, RUS, Russia

Site Status

St Petersburg NHI City Polytclinic #77 City Diabetological Center #4

Saint Petersburg, RUS, Russia

Site Status

Central Medical Sanitary Unit #122

Saint Petersburg, RUS, Russia

Site Status

St Petersburg NHI Municipal Multi-Speciality Hospital # 2

Saint Petersburg, RUS, Russia

Site Status

St Petersburg Medical Academy St Elizabeth Hospital

Saint Petersburg, RUS, Russia

Site Status

Pavlov State Medical Univ of St Petersburg

Saint Petersburg, RUS, Russia

Site Status

TUV Medico-Military Academy

Saint Petersburg, RUS, Russia

Site Status

NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital

Smolensk, RUS, Russia

Site Status

Clinical Pharm Dept of Yaroslavl Clin Hospital

Yaroslavl, RUS, Russia

Site Status

MHI Clinical Hospital for Emergency Care na NV Soloviev

Yaroslavl, RUS, Russia

Site Status

MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant

Yaroslavl, RUS, Russia

Site Status

NHI Yaroslavl Regional Clinical Hospital

Yaroslavl, RUS, Russia

Site Status

Yaroslavl Regional Clinical Hospital

Yaroslavl, RUS, Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Brazil Canada Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MKC-TI-126

Identifier Type: -

Identifier Source: org_study_id