Clinical trial NCT00741429: A 2-Month Safety Follow-Up Trial
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 649
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126
timeFrame: 9 to 27 months
Secondary outcomes:
measure: Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126
timeFrame: 9 to 27 months
measure: Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126
timeFrame: 9 to 27 months
measure: Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126
timeFrame: 9 to 27 months
measure: Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126
timeFrame: 3 Months
measure: Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126
timeFrame: 3 Months
measure: Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126
timeFrame: 3 Months
measure: Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126
timeFrame: 3 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Chandler
country: United States
facility: Radiant Research (Phoenix)
state: Arizona
city: Phoenix
country: United States
facility: Southwest Health Ltd Research Division
state: Arizona
city: Phoenix
country: United States
facility: Northwest Medical Center
state: Arizona
city: Tucson
country: United States
facility: Canyon Clinical Research
state: Arizona
city: Tuscon
country: United States
facility: Arizona Research Associates
state: Arizona
city: Burlingame
country: United States
facility: Private Practice
state: California
city: Chula Vista
country: United States
facility: International Clinical Research Network
state: California
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Fresno
country: United States
facility: Saad Hijazi MD Inc
state: California
city: Fresno
country: United States
facility: Saint Agnes Medical Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Garden Grove
country: United States
facility: Digestive & Liver Disease Specialist A Medical Group Inc
state: California
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Management and Research Center
state: California
city: Los Alamitos
country: United States
facility: Interlink Research Institute
state: California
city: Pasadena
country: United States
facility: Southern California Endocrine Center
state: California
city: San Mateo
country: United States
facility: Dorothy L & James E Frank Diabetes Research Institute
state: California
city: Santa Barbara
country: United States
facility: Sansum Medical Research Institute
state: California
city: Santa Monica
country: United States
facility: Coastal Biomedical Research Inc
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: Diabetes Research Center
state: California
city: Denver
country: United States
facility: Creekside Endocrine Associates
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research LLC
state: Connecticut
city: Hollywood
country: United States
facility: Center for Diabetes & Endocrine Care
state: Florida
city: Miami
country: United States
facility: University of Miami Diabetes Research Institute
state: Florida
city: Miami
country: United States
facility: International Research Associates LLC
state: Florida
city: Atlanta
country: United States
facility: Laureate Clinical Research Group
state: Georgia
city: Atlanta
country: United States
facility: Executive Health and Research Associates Inc
state: Georgia
city: Conyers
country: United States
facility: Rockdale Medical Research Associates
state: Georgia
city: Decatur
country: United States
facility: Private Practice
state: Georgia
city: Dunwoody
country: United States
facility: Atlanta Pharmaceutical Research Center
state: Georgia
city: Lawrenceville
country: United States
facility: North Atlanta Endocrinology & Diabetes PC
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: John H Stoger Jr Hospital of Cook County
state: Illinois
city: Baltimore
country: United States
facility: MODEL Clinical Research
state: Maryland
city: Baltimore
country: United States
facility: Health Trends Research LLC
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital
state: Maryland
city: Towson
country: United States
facility: James A Dicke MDPA
state: Maryland
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: St Clair Shores
country: United States
facility: KMED Research
state: Michigan
city: Edina
country: United States
facility: Radiant Research Inc (Minneapolis)
state: Minnesota
city: Minneapolis
country: United States
facility: Center for Urologic Clinical Trials University of Minnesota
state: Minnesota
city: Florissant
country: United States
facility: Healthcare Research
state: Missouri
city: St Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: St Louis
country: United States
facility: MedEx Healthcare Research Inc(009)
state: Missouri
city: St Peters
country: United States
facility: Amin Radparvar's Private Practice
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic Research Center
state: Montana
city: Billings
country: United States
facility: Montana Health Research Institute
state: Montana
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Hillsborough
country: United States
facility: Your Doctors Care
state: New Jersey
city: Trenton
country: United States
facility: Hopewell Valley Medical Group
state: New Jersey
city: Voorhees
country: United States
facility: Umdnj-Som
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center
state: New Mexico
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources (Albuquerque)
state: New Mexico
city: Albuquerque
country: United States
facility: Southwest Endocrinology Associates
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico HCS
state: New Mexico
city: Flushing
country: United States
facility: Diabetes Care & Information Center of New York
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hyde Park
country: United States
facility: North Shore Diabetes and Endocrine Associates
state: New York
city: New York
country: United States
facility: M.E.R.I.
state: New York
city: Staten Island
country: United States
facility: Univeristy of Physicians Group Endocrine Division
state: New York
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Charlotte
country: United States
facility: Sensenbrenner Primary Care
state: North Carolina
city: Greenville
country: United States
facility: Physician's East PA
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research Inc
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center of Clinical Research
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Mentor
country: United States
facility: Your Diabetes Endocrine Nutrition Group
state: Ohio
city: Portland
country: United States
facility: Portland Diabetes & Endocrinology Center
state: Oregon
city: Portland
country: United States
facility: Legacy Clinical Research
state: Oregon
city: Portland
country: United States
facility: Covance CRU Inc.
state: Oregon
city: Morrisville
country: United States
facility: Bucks County Clinical Research
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Taylors
country: United States
facility: Southeastern Research Associates Inc
state: South Carolina
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Collierville
country: United States
facility: Collierville Medical Specialists
state: Tennessee
city: Memphis
country: United States
facility: Memphis Internal Medicine PLLC
state: Tennessee
city: Arlington
country: United States
facility: Israel Hartman MD
state: Texas
city: Colleyville
country: United States
facility: Texas Familicare Clinical Research
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes & Endocrine Center
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Radiant Research Dallas-North
state: Texas
city: Dallas
country: United States
facility: Baylor Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Galenos Research
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Friendswood
country: United States
facility: Spuhler Medical Associates
state: Texas
city: Plano
country: United States
facility: SMO: Pharmaceuticals C-Trials North Texas Medical Research
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Center Inc
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: San Antonio
country: United States
facility: Covenant Clinic Research
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc PA
state: Texas
city: San Antonio
country: United States
facility: SAM Clinical Research Center
state: Texas
city: Temple
country: United States
facility: Scott & White Hospital and Clinic
state: Texas
city: Bountiful
country: United States
facility: Pharmaceutical Research Organization
state: Utah
city: Magna
country: United States
facility: Magna Center for Family Medicine
state: Utah
city: Salt Lake City
country: United States
facility: Radiant Research Salt Lake City
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: West Valley City
country: United States
facility: Granger Medical Clinic
state: Utah
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Medical Group
state: Virginia
city: Federal Way
country: United States
facility: Larry D Stonesifer MD Inc PS
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center Inc
state: Washington
city: Tacoma
country: United States
facility: Cedar Research
state: Washington
city: Tacoma
country: United States
facility: Liberty Research Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center Clinical Research Department
state: Washington
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Sao Paulo
country: Brazil
facility: CPClin-Centro de Pesquisas Clinicas
city: Brampton
country: Canada
facility: Aggarwal and Associates Ltd
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Markham
country: Canada
facility: Quest Clinical Trials
state: Ontario
city: Oakville
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Sarnia
country: Canada
facility: Sarnia Institute of Clinical Research
state: Ontario
city: Sarnia
country: Canada
facility: The London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Thornhill
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Toronto
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Toronto
country: Canada
facility: Trial Management Group Inc (Henein
state: Ontario
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical Academy of Ministry of Health
state: RUS
city: Kemerovo
country: Russian Federation
facility: NHI Kemerovo Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow State Medical-Stomatological University City Clinical Hospital # 23
state: RUS
city: Moscow
country: Russian Federation
facility: NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
state: RUS
city: Moscow
country: Russian Federation
facility: Russian State Medical University City Hospital # 4
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital # 13
state: RUS
city: Moscow
country: Russian Federation
facility: SHI of Moscow City Clinical Hospital #13
state: RUS
city: Moscow
country: Russian Federation
facility: NI Central Clinical Hospital of RAS
state: RUS
city: Moscow
country: Russian Federation
facility: Russian State Medical University Central Clinical Hospital Russian Science Academy
state: RUS
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 61
state: RUS
city: Moscow
country: Russian Federation
facility: SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
state: RUS
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Restoration Medicine & Balneology
state: RUS
city: Moscow
country: Russian Federation
facility: SI Internal Affairs of Moscow- Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: RAAMS Endocrinology and Diabetology Department
state: RUS
city: Moscow
country: Russian Federation
facility: SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
state: RUS
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University na academician IP Pavlov
state: RUS
city: Smolensk
country: Russian Federation
facility: NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
state: RUS
city: St Petersburg
country: Russian Federation
facility: St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
state: RUS
city: St Petersburg
country: Russian Federation
facility: Central Medical Sanitary Unit #122
state: RUS
city: St Petersburg
country: Russian Federation
facility: St Petersburg Medical Academy St Elizabeth Hospital
state: RUS
city: St Petersburg
country: Russian Federation
facility: Pavlov State Medical Univ of St Petersburg
state: RUS
city: St Petersburg
country: Russian Federation
facility: TUV Medico-Military Academy
state: RUS
city: St. Petersburg
country: Russian Federation
facility: St Petersburg NHI Municipal Multi-Speciality Hospital # 2
state: RUS
city: Yaroslavl
country: Russian Federation
facility: Clinical Pharm Dept of Yaroslavl Clin Hospital
state: RUS
city: Yaroslavl
country: Russian Federation
facility: MHI Clinical Hospital for Emergency Care na NV Soloviev
state: RUS
city: Yaroslavl
country: Russian Federation
facility: MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
state: RUS
city: Yaroslavl
country: Russian Federation
facility: NHI Yaroslavl Regional Clinical Hospital
state: RUS
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital
state: RUS
Study officials:
References: