Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

October 9, 2014 updated by: Mannkind Corporation

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.

Pulmonary Safety in Diabetics with T/I

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2053

Phase

  • Phase 3

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

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
        • Finchlea Medical Group
      • Courtice, Ontario, Ontario, Canada, L1E 3C3
        • Courtice Health Centre
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital
      • Markham, Ontario, Canada, L6B 1A1
        • Quest Clinical Trials
      • 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, M4K 1N5
        • Albany Medical Center
      • Toronto, Ontario, Canada, M9W 4L6
        • Manna Research
      • Toronto, Ontario, Canada, M4R 2G4
        • Lifestyle Metabolism Center (600-118 Eglinton Ave W)
  • Czech Republic
    • CZE
      • Litomerice, CZE, Czech Republic, 41201
        • Diabetologicka ambulance
      • Melnik, CZE, Czech Republic, 276 01
        • Surgery of Diabetology
      • Ostrava - Poruba, CZE, Czech Republic, 708 52
        • Internal Clinic
      • Ostrava 1, CZE, Czech Republic, 70200
        • Diabetologicka a interni ambulance
      • Ostrava-Kuncice, CZE, Czech Republic, 70702
        • Diabetologicka a interni ambulance
      • Prague 15, CZE, Czech Republic, 109 00
        • Surgery of Diabetology Petrovice
      • Praha 6, CZE, Czech Republic, 150 06
        • FN Motol Interni Klinika
  • Poland
    • POL
      • Bialystock, POL, Poland, 15-276
        • Klinika Endocrinologii Diabetologii I
      • Bialystock, POL, Poland, 15-950
        • Oddzial Chorob Wewnetrznych
      • Krakow, POL, Poland, 30 510
        • Dzial Badan Klinicznych Malopoiskie
      • Krakow, POL, Poland, 31121
        • III Oddzial Chorob Wewnetrznych Szpital
      • Krakow, POL, Poland, 31-261
        • Endokrynologiczno Metaboliczne DIAB_ENDO_MET
      • Lask, POL, Poland, 98-100
        • Oddzial Internistyczny Specjalistyczna
      • Lodz, POL, Poland, 092-003
        • Oddzial Wewnetrzny B
      • Lodz, POL, Poland, 90 153
        • Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
      • Lodz, POL, Poland, 93-338
        • Oddzial Diabetologiczny Centrum
      • Pruszkow, POL, Poland, 05-800
        • Spzital Kolejowy imm Wlodzimierza Roeflera
      • Warsaw, POL, Poland, 02-097
        • Katedra i Klinika Gastroentereologii i
      • Warsaw, POL, Poland, 02-507
        • Oddzial Chorob Wewnetznych i Diabetologii
      • Warsaw, POL, Poland, 05-400
        • ZPZOZ w Otwocku Szpital Miejski
      • Warszawa, POL, Poland, 00-416
        • Klinika Medycyny Rodzinnej i Chorob
  • Russian Federation
      • Moscow, Russian Federation, 105077
        • Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
    • 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, 125315
        • RAAMS Endocrinology and Diabetology Department
      • Moscow, RUS, Russian Federation, 113093
        • Russian State Medical University City Hospital # 4
      • Moscow, RUS, Russian Federation, 117593
        • Russian State Medical University Central Clinical Hospital Russian Science Academy
      • Moscow, RUS, Russian Federation, 127644
        • SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
      • Moscow, RUS, Russian Federation, 115478
        • NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
      • Moscow, RUS, Russian Federation, 117036
        • Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
      • Moscow, RUS, Russian Federation, 129110
        • NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
      • Moscow, RUS, Russian Federation, 150062
        • Municipal Clinical Hospital #13
      • Moscow, RUS, Russian Federation
        • Moscow State Medical-Stomatological University City Clinical Hospital # 23
      • 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, 107110
        • Krestovsky Island Medical Institute
      • 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, 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
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial
    • ESP
      • Barcelona, ESP, Spain, 08017
        • Fundacio Sarda Farriol
      • Madrid, ESP, Spain, 28040
        • Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion
      • Madrid, ESP, Spain, 28041
        • Hospital 12 de Octubre Consultas Extremas - Endocrinologia
      • Madrid, ESP, Spain, 28046
        • Hospital Universitario de La Paz
      • Sevilla, ESP, Spain, 41009
      • Sevilla, ESP, Spain, 41013
        • Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja
  • Ukraine
      • Kiev, Ukraine, 02147
        • Outpatient Clinic of Family Physician "Rusanovka"
      • Odessa, Ukraine, 65114
        • Public Institution City Policlinic #20 Odessa
    • UKR
      • Chernivtcy, UKR, Ukraine, 58022
        • Bukovinian State Medical University Dept of Clinical Immun
      • Dniepropetrovsk, UKR, Ukraine, 49023
        • Dniepropetrovsh State Medical Academy
      • Donetsk, UKR, Ukraine, 83003
        • Donetsk State Medical University
      • Donetsk, UKR, Ukraine, 83009
        • Donetsk State Medical University
      • Donetsk, UKR, Ukraine, 83114
        • Railway Clinical Hospital on Donetsk Station
      • Kharkiv, UKR, Ukraine, 61070
        • V Danilevsky Inst of Endocrinology Pathology
      • Kiev, UKR, Ukraine, 04050
        • Chair Family Med of National Med University
      • Kiev, UKR, Ukraine, 01004
        • Medical University at Kiev Center of Endocrinology and Metab
      • Kiev, UKR, Ukraine, 2175
        • Ukr Scientifically Practical Centre of Endocrine Surgery
      • Lugansk, UKR, Ukraine, 91045
        • Lugansk State Medical University Chair of Hosp Therapy #2
      • Lugansk, UKR, Ukraine, 91045
        • Lugansk State Medical University Chair of Therapy #1
      • Lvov, UKR, Ukraine, 79010
        • Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University
      • Odessa, UKR, Ukraine, 65009
        • Odessa State Medical University Dept of Gen Practice and Med Rehab
      • Odessa, UKR, Ukraine, 65025
        • Odessa Reg. Clinical Hosp Outpatient Department
      • Odessa, UKR, Ukraine, 65039
        • Odessa State Med Dept of Family Med and Gen Practice
      • Simferopol, UKR, Ukraine, 95017
        • Crimean State Medical University Dept of Therapy #1
      • Vinnitsa, UKR, Ukraine, 21020
        • Vinnitsa State Medical University
  • United Kingdom
    • GBR
      • Barnsley, GBR, United Kingdom, S75 2EP
        • Barnsley Hospital
      • Doncaster, GBR, United Kingdom, DN3 2LX
        • Kingthorne Group Practice
      • Leeds, GBR, United Kingdom, LS9 7TF
        • Manny Cussins Centre
      • Liverpool, GBR, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, GBR, United Kingdom, E1 2AT
        • Clinical Research Centre The Royal London Hospital
      • Middlesex, GBR, United Kingdom, HA6 2RN
        • Medinova Research Mount Vernon Hospital
      • Petersborough, GBR, United Kingdom, PE3 9GZ
        • Edith Cavel Hospital Diabetes Centre
      • Sheffield, GBR, United Kingdom, S5 7AU
        • Northern General Hospital
      • Suffolk, GBR, United Kingdom, IP30 9QU
        • Woolpit Medical Practice
      • Suffolk, GBR, United Kingdom, IP33 2QZ
        • West Suffolk Hospital
      • West Midlands, GBR, United Kingdom, B9 5SS
        • Birmingham Heartland Hospital
      • West Yorkshire, GBR, United Kingdom, BD9 6RJ
        • Bradford Hospital Dept of Diabetes & Endocrinology
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85029
        • Northwest Medical Center
      • Phoenix, Arizona, United States, 85016
        • Southwest Health Ltd Research Division
      • Phoenix, Arizona, United States, 85018
        • Lovelace Scientific Resources
      • Phoenix, Arizona, United States, 85032
        • Arizona Center For Clinical Research
      • Tempe, Arizona, United States, 85282
        • Premiere Pharmaceutical Research LLC
      • Tucson, Arizona, United States, 85712
        • Canyon Clinical Research
      • Tuscon, Arizona, United States, 85712
        • Arizona Research Associates
    • California
      • Burlingame, California, United States, 94010
        • Private Practice
      • Fresno, California, United States, 93720
        • Saint Agnes Medical Center
      • Fresno, California, United States, 93720
        • Valley Research
      • Garden Grove, California, United States, 92840
        • (Private Practice)
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Management Center
      • Los Alamitos, California, United States, 90720
        • Interlink Research Institute
      • Salinas, California, United States, 93901
        • Diabetes Care Center
      • San Diego, California, United States, 92120
        • San Diego Sports Medicine and Family Health 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
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente
      • Denver, Colorado, United States, 80220
        • Denver VA Medical Center
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Alliance Medical Group of Greater Waterbury
      • New Britain, Connecticut, United States, 06050
        • New Britain General Hosptal c?o Betsy Keller
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Executive Health and Research Associates Inc
      • Atlanta, Georgia, United States, 30338
        • Perimeter Institute for Clinical Research (PICR)
      • Conyers, Georgia, United States, 30094
        • Rockdale Medical Research Associates
      • Decatur, Georgia, United States, 30035-4000
        • 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
        • Southeastern Endocrine & Diabetes
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Fox Valley Clinical Research Center LLC
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • Medical Research of Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic and Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital
      • Baltimore, Maryland, United States, 21208-6391
        • Health Trends Research LLC
      • Towson, Maryland, United States, 21204
        • Model Clinical Research
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
        • East Coast Clinical Research Inc
      • Waltham, Massachusetts, United States, 02453
        • Clinical research
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Michigan Institute of Medicine
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • PPS Clinical Research / Southwest Medical Center
      • Florissant, Missouri, United States, 63031
        • HealthCare Research
      • St Louis, Missouri, United States, 63117
        • Medex Healthcare Research Inc
      • 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
        • Billings Clinic Research Division
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • Your Doctors Care
      • Trenton, New Jersey, United States, 08618
        • Hopewell Valley Family Medicine PA
      • Voorhees, New Jersey, United States, 08084
        • Umdnj-Som
    • New Mexico
      • 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
      • Brooklyn, New York, United States, 11216
        • Physicians Associates of Park Place
      • Flushing, New York, United States, 11365
        • Diabetes Care & Information Center of New York
      • New York, New York, United States, 10021
        • Eastside Comprehensive Medical Center
      • New York, New York, United States, 10023
        • M.E.R.I.
      • White Plains, New York, United States, 10604
        • Physicians Clinical Research Service (PCRS) (SMO)
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Metrolina Medical Research
      • Greenville, North Carolina, United States, 27834
        • Endocrine Research - Physician's East PA
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research Inc
      • Mentor, Ohio, United States, 44060
        • Your Diabetes Endocrine Nutrition Group
    • Oregon
      • Portland, Oregon, United States, 97219
        • New Hope Research of Oregon
    • Pennsylvania
      • Doyleston, Pennsylvania, United States, 18912
        • Buckingham Family Medicine
      • Morrisville, Pennsylvania, United States, 19067
        • Bucks County Clinical Research
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Upstate Pharmaceutical Research
    • Texas
      • Colleyville, Texas, United States, 76034
        • Texas Familicare Clinical Research
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes & Endocrine Center
      • Houston, Texas, United States, 77030
        • Houston Medical Research Associates
      • Plano, Texas, United States, 75093
        • North Texas Medical Research
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Research Assoc PA
      • Temple, Texas, United States, 76508
        • Scott & White Hospital and Clinic
      • Waco, Texas, United States, 76707
        • McLennan County Medical Education and Research Foundation
    • Utah
      • 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, 84041
        • Davis Family Practice
      • Salt Lake City, Utah, United States, 84107
        • Southeastern PA Med Inst LLC (SMO)
      • West Valley City, Utah, United States, 84120
        • Granger Medical Clinic
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Hampton Roads Center for Clinical Research Inc
    • Washington
      • Renton, Washington, United States, 98055
        • Rainier Clinical Research Center Inc
      • Wenatchee, Washington, United States, 98801
        • Clinical Research Department Wenatchee Valley Medical Center

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

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual care
Drug: Usual Care
Subjects will receive antidiabetes treatment at the discretion of their physicians
Experimental: TI Inhalation Powder
Technosphere® Insulin Inhalation Powder
Drug: Technosphere® Insulin Inhalation Powder
Inhalation, 15U/30U
No Intervention: Non-diabetes
Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
Time Frame: Baseline to Month 24
Change from Baseline to End of Study in FEV1 by MMRM
Baseline to Month 24
FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
Time Frame: Baseline to Month 24
FEV1 decrease of ≥ 15% from Baseline value at last measurement
Baseline to Month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care
Time Frame: Baseline to Month 24
Change from Baseline to last measurement(Month 24) in FEV1
Baseline to Month 24
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM
Time Frame: Baseline to Month 24
Change from Baseline to Month 24 in FVC by MMRM
Baseline to Month 24
Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM
Time Frame: Baseline to Month 24
Change from baseline to Month 24 in TLC by MMRM
Baseline to Month 24
Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM
Time Frame: Baseline to Month 24
Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM
Baseline to Month 24
Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement
Time Frame: Baseline to Month 24
FVC Decrease of ≥15% from Baseline Value at Last Measurement
Baseline to Month 24
Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement
Time Frame: Baseline to Month 24
TLC Decrease of ≥ 15% from Baseline Value at Last Measurement
Baseline to Month 24
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement
Time Frame: Baseline to Month 24
Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement
Baseline to Month 24
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement
Time Frame: Baseline to Month 24
Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement
Baseline to Month 24
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care
Time Frame: Baseline to Month 24
Change from baseline in HbA1c at last measurement
Baseline to Month 24
Change in Weight From Baseline at Month 24
Time Frame: Baseline to Month 24
Change from baseline in weight at Month 24
Baseline to Month 24

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

June 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 28, 2006

First Submitted That Met QC Criteria

March 28, 2006

First Posted (Estimate)

March 30, 2006

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-TI-030

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.

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