Clinical trial NCT00308737: Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Official title: Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes, Type 1
Diabetes, Type 2
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2006-03-30
Enrollment: 2053
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary Safety in Diabetics with T/I


Eligibility criteria: Inclusion Criteria:

* For All Subjects:

  * Nonsmoking
  * Body mass index \<42 kg/m2
  * FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
  * No abnormalities in screening pulmonary radiology
* For Subjects with diabetes mellitus:

  * Type 1 or type 2 diabetes for at least 2 years
  * HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %
* For Subjects without abnormalities in glucose control:

  * No history of diabetes
  * Normal results from a formal glucose tolerance test

Exclusion Criteria:

* History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
* Significant renal, hepatic, or cardiac disease
* Women who are pregnant, lactating, or planning on becoming pregnant
* Subjects who have participated in studies of other investigational drugs within the previous 3 months
* Evidence of severe complications of diabetes

Primary outcomes:
measure: Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
timeFrame: Baseline to Month 24
measure: FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
timeFrame: Baseline to Month 24
Secondary outcomes:
measure: Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care
timeFrame: Baseline to Month 24
measure: Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM
timeFrame: Baseline to Month 24
measure: Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM
timeFrame: Baseline to Month 24
measure: Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM
timeFrame: Baseline to Month 24
measure: Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement
timeFrame: Baseline to Month 24
measure: Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement
timeFrame: Baseline to Month 24
measure: Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement
timeFrame: Baseline to Month 24
measure: Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement
timeFrame: Baseline to Month 24
measure: Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care
timeFrame: Baseline to Month 24
measure: Change in Weight From Baseline at Month 24
timeFrame: Baseline to Month 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Health Ltd Research Division
state: Arizona
city: Phoenix
country: United States
facility: Lovelace Scientific Resources
state: Arizona
city: Phoenix
country: United States
facility: Northwest Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Center for Clinical Research
state: Arizona
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research LLC
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: 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: (Private Practice)
state: California
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Management Center
state: California
city: Los Alamitos
country: United States
facility: Interlink Research Institute
state: California
city: Salinas
country: United States
facility: Diabetes Care Center
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine and Family Health 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: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Denver
country: United States
facility: Kaiser Permanente
state: Colorado
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Middlebury
country: United States
facility: Alliance Medical Group of Greater Waterbury
state: Connecticut
city: New Britain
country: United States
facility: New Britain General Hosptal c?o Betsy Keller
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research (PICR)
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: Southeastern Endocrine & Diabetes
state: Georgia
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center LLC
state: Illinois
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates
state: Illinois
city: Metairie
country: United States
facility: Medical Research of Louisiana
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic and Foundation
state: Louisiana
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: MODEL Clinical Research
state: Maryland
city: Haverhill
country: United States
facility: East Coast Clinical Research Inc
state: Massachusetts
city: Waltham
country: United States
facility: Clinical Research
state: Massachusetts
city: Livonia
country: United States
facility: Michigan Institute of Medicine
state: Michigan
city: Chesterfield
country: United States
facility: PPS Clinical Research / Southwest Medical Center
state: Missouri
city: Florissant
country: United States
facility: Healthcare Research
state: Missouri
city: St Louis
country: United States
facility: MedEx Healthcare Research Inc
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: Billings Clinic Research Division
state: Montana
city: Hillsborough
country: United States
facility: Your Doctors Care
state: New Jersey
city: Trenton
country: United States
facility: Hopewell Valley Family Medicine PA
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: Brooklyn
country: United States
facility: Physicians Associates of Park Place
state: New York
city: Flushing
country: United States
facility: Diabetes Care & Information Center of New York
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: New York
country: United States
facility: M.E.R.I.
state: New York
city: White Plains
country: United States
facility: Physicians Clinical Research Service (PCRS) (SMO)
state: New York
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Greenville
country: United States
facility: Endocrine Research - Physician's East PA
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research Inc
state: Ohio
city: Mentor
country: United States
facility: Your Diabetes Endocrine Nutrition Group
state: Ohio
city: Portland
country: United States
facility: New Hope Research of Oregon
state: Oregon
city: Doyleston
country: United States
facility: Buckingham Family Medicine
state: Pennsylvania
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: 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: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Plano
country: United States
facility: North Texas Medical Research
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc PA
state: Texas
city: Temple
country: United States
facility: Scott & White Hospital and Clinic
state: Texas
city: Waco
country: United States
facility: McLennan County Medical Education and Research Foundation
state: Texas
city: Magna
country: United States
facility: Magna Center for Family Medicine
state: Utah
city: Salt Lake City
country: United States
facility: Davis Family Practice
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: Southeastern PA Med Inst LLC (SMO)
state: Utah
city: West Valley City
country: United States
facility: Granger Medical Clinic
state: Utah
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research Inc
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center Inc
state: Washington
city: Wenatchee
country: United States
facility: Clinical Research Department Wenatchee Valley Medical Center
state: Washington
city: Brampton
country: Canada
facility: Finchlea Medical Group
state: Ontario
city: Courtice, Ontario
country: Canada
facility: Courtice Health Centre
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Markham
country: Canada
facility: Quest Clinical Trials
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: Albany Medical Center
state: Ontario
city: Toronto
country: Canada
facility: Lifestyle Metabolism Center (600-118 Eglinton Ave W)
state: Ontario
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: Litomerice
country: Czech Republic
facility: Diabetologicka ambulance
state: CZE
city: Melnik
country: Czech Republic
facility: Surgery of Diabetology
state: CZE
city: Ostrava - Poruba
country: Czech Republic
facility: Internal Clinic
state: CZE
city: Ostrava 1
country: Czech Republic
facility: Diabetologicka a interni ambulance
state: CZE
city: Ostrava-Kuncice
country: Czech Republic
facility: Diabetologicka a interni ambulance
state: CZE
city: Prague 15
country: Czech Republic
facility: Surgery of Diabetology Petrovice
state: CZE
city: Praha 6
country: Czech Republic
facility: FN Motol Interni Klinika
state: CZE
city: Bialystock
country: Poland
facility: Klinika Endocrinologii Diabetologii I
state: POL
city: Bialystock
country: Poland
facility: Oddzial Chorob Wewnetrznych
state: POL
city: Krakow
country: Poland
facility: Dzial Badan Klinicznych Malopoiskie
state: POL
city: Krakow
country: Poland
facility: Endokrynologiczno Metaboliczne DIAB_ENDO_MET
state: POL
city: Krakow
country: Poland
facility: III Oddzial Chorob Wewnetrznych Szpital
state: POL
city: Lask
country: Poland
facility: Oddzial Internistyczny Specjalistyczna
state: POL
city: Lodz
country: Poland
facility: Oddzial Wewnetrzny B
state: POL
city: Lodz
country: Poland
facility: Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
state: POL
city: Lodz
country: Poland
facility: Oddzial Diabetologiczny Centrum
state: POL
city: Pruszkow
country: Poland
facility: Spzital Kolejowy imm Wlodzimierza Roeflera
state: POL
city: Warsaw
country: Poland
facility: Katedra i Klinika Gastroentereologii i
state: POL
city: Warsaw
country: Poland
facility: Oddzial Chorob Wewnetznych i Diabetologii
state: POL
city: Warsaw
country: Poland
facility: ZPZOZ w Otwocku Szpital Miejski
state: POL
city: Warszawa
country: Poland
facility: Klinika Medycyny Rodzinnej i Chorob
state: POL
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: Russian State Medical University City Hospital # 4
state: RUS
city: Moscow
country: Russian Federation
facility: NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
state: RUS
city: Moscow
country: Russian Federation
facility: Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
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: 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: Moscow
country: Russian Federation
facility: NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
state: RUS
city: Moscow
country: Russian Federation
facility: Municipal Clinical Hospital #13
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow State Medical-Stomatological University City Clinical Hospital # 23
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: Krestovsky Island Medical Institute
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: 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: NHI Yaroslavl Regional Clinical Hospital
state: RUS
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
city: Barcelona
country: Spain
facility: Fundacio Sarda Farriol
state: ESP
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion
state: ESP
city: Madrid
country: Spain
facility: Hospital 12 de Octubre Consultas Extremas - Endocrinologia
state: ESP
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz
state: ESP
city: Sevilla
country: Spain
state: ESP
city: Sevilla
country: Spain
facility: Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja
state: ESP
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Chernivtcy
country: Ukraine
facility: Bukovinian State Medical University Dept of Clinical Immun
state: UKR
city: Dniepropetrovsk
country: Ukraine
facility: Dniepropetrovsh State Medical Academy
state: UKR
city: Donetsk
country: Ukraine
facility: Donetsk State Medical University
state: UKR
city: Donetsk
country: Ukraine
facility: Donetsk State Medical University
state: UKR
city: Donetsk
country: Ukraine
facility: Railway Clinical Hospital on Donetsk Station
state: UKR
city: Kharkiv
country: Ukraine
facility: V Danilevsky Inst of Endocrinology Pathology
state: UKR
city: Kiev
country: Ukraine
facility: Medical University at Kiev Center of Endocrinology and Metab
state: UKR
city: Kiev
country: Ukraine
facility: Chair Family Med of National Med University
state: UKR
city: Kiev
country: Ukraine
facility: Ukr Scientifically Practical Centre of Endocrine Surgery
state: UKR
city: Lugansk
country: Ukraine
facility: Lugansk State Medical University Chair of Hosp Therapy #2
state: UKR
city: Lugansk
country: Ukraine
facility: Lugansk State Medical University Chair of Therapy #1
state: UKR
city: Lvov
country: Ukraine
facility: Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University
state: UKR
city: Odessa
country: Ukraine
facility: Odessa State Medical University Dept of Gen Practice and Med Rehab
state: UKR
city: Odessa
country: Ukraine
facility: Odessa Reg. Clinical Hosp Outpatient Department
state: UKR
city: Odessa
country: Ukraine
facility: Odessa State Med Dept of Family Med and Gen Practice
state: UKR
city: Simferopol
country: Ukraine
facility: Crimean State Medical University Dept of Therapy #1
state: UKR
city: Vinnitsa
country: Ukraine
facility: Vinnitsa State Medical University
state: UKR
city: Kiev
country: Ukraine
facility: Outpatient Clinic of Family Physician "Rusanovka"
city: Odessa
country: Ukraine
facility: Public Institution City Policlinic #20 Odessa
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital
state: GBR
city: Doncaster
country: United Kingdom
facility: Kingthorne Group Practice
state: GBR
city: Leeds
country: United Kingdom
facility: Manny Cussins Centre
state: GBR
city: Liverpool
country: United Kingdom
facility: Royal liverpool University Hospital
state: GBR
city: London
country: United Kingdom
facility: Clinical Research Centre The Royal London Hospital
state: GBR
city: Middlesex
country: United Kingdom
facility: Medinova Research Mount Vernon Hospital
state: GBR
city: Petersborough
country: United Kingdom
facility: Edith Cavel Hospital Diabetes Centre
state: GBR
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
state: GBR
city: Suffolk
country: United Kingdom
facility: Woolpit Medical Practice
state: GBR
city: Suffolk
country: United Kingdom
facility: West Suffolk Hospital
state: GBR
city: West Midlands
country: United Kingdom
facility: Birmingham Heartland Hospital
state: GBR
city: West Yorkshire
country: United Kingdom
facility: Bradford Hospital Dept of Diabetes & Endocrinology
state: GBR
Study officials:
References: