Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00308737
First received: March 28, 2006
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

Pulmonary Safety in Diabetics with T/I


Condition Intervention Phase
Diabetes, Type I
Diabetes Type 2
Drug: Technosphere Insulin
Drug: Usual Care
Other: No Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • To evaluate and compare changes in pulmonary function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate and compare glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2343
Study Start Date: June 2005
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Technosphere Insulin
Drug: Technosphere Insulin
Inhalation, 15U/30U
2
Usual care
Drug: Usual Care
Subjects will receive antidiabetes treatment at the discretion of their physicians
No Intervention: 3
Subjects without abnormalities in glucose control
Other: No Intervention
No intervention

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308737

  Hide Study Locations
Locations
United States, Arizona
Northwest Medical Center
Phoenix, Arizona, United States, 85029
Arizona Center for Clinical Research
Phoenix, Arizona, United States, 85032
Lovelace Scientific Resources
Phoenix, Arizona, United States, 85018
Southwest Health Ltd Research Division
Phoenix, Arizona, United States, 85016
Premiere Pharmaceutical Research LLC
Tempe, Arizona, United States, 85282
Canyon Clinical Research
Tucson, Arizona, United States, 85712
Arizona Research Associates
Tuscon, Arizona, United States, 85712
United States, California
Private Practice
Burlingame, California, United States, 94010
Saint Agnes Medical Center
Fresno, California, United States, 93720
Valley Research
Fresno, California, United States, 93720
(Private Practice)
Garden Grove, California, United States, 92840
Diabetes/Lipid Management Center
Huntington Beach, California, United States, 92648
Interlink Research Institute
Los Alamitos, California, United States, 90720
Diabetes Care Center
Salinas, California, United States, 93901
San Diego Sports Medicine and Family Health Center
San Diego, California, United States, 92120
Dorothy L & James E Frank Diabetes Research Institute
San Mateo, California, United States, 94401
Sansum Medical Research Institute
Santa Barbara, California, United States, 93105
Encompass Clinical Research
Spring Valley, California, United States, 91978
United States, Colorado
Kaiser Permanente
Denver, Colorado, United States, 80205
Denver VA Medical Center
Denver, Colorado, United States, 80220
United States, Connecticut
Alliance Medical Group of Greater Waterbury
Middlebury, Connecticut, United States, 06762
New Britain General Hosptal c?o Betsy Keller
New Britain, Connecticut, United States, 06050
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Georgia
Executive Health and Research Associates Inc
Atlanta, Georgia, United States, 30342
Perimeter Institute for Clinical Research (PICR)
Atlanta, Georgia, United States, 30338
Rockdale Medical Research Associates
Conyers, Georgia, United States, 30094
Private Practice
Decatur, Georgia, United States, 30035-4000
Atlanta Pharmaceutical Research Center
Dunwoody, Georgia, United States, 30338
North Atlanta Endocrinology & Diabetes PC
Lawrenceville, Georgia, United States, 30045
Southeastern Endocrine & Diabetes
Roswell, Georgia, United States, 30076
United States, Illinois
Fox Valley Clinical Research Center LLC
Aurora, Illinois, United States, 60504
Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
Deerbrook Medical Associates
Vernon Hills, Illinois, United States, 60061
United States, Louisiana
Medical Research of Louisiana
Metairie, Louisiana, United States, 70001
Ochsner Clinic and Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Health Trends Research LLC
Baltimore, Maryland, United States, 21208-6391
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
MODEL Clinical Research
Towson, Maryland, United States, 21204
United States, Massachusetts
East Coast Clinical Research Inc
Haverhill, Massachusetts, United States, 01830
Clinical Research
Waltham, Massachusetts, United States, 02453
United States, Michigan
Michigan Institute of Medicine
Livonia, Michigan, United States, 48152
United States, Missouri
PPS Clinical Research / Southwest Medical Center
Chesterfield, Missouri, United States, 63017
Healthcare Research
Florissant, Missouri, United States, 63031
MedEx Healthcare Research Inc
St Louis, Missouri, United States, 63117
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, Montana
Billings Clinic Research Division
Billings, Montana, United States, 59101
United States, New Jersey
Your Doctors Care
Hillsborough, New Jersey, United States, 08844
Hopewell Valley Family Medicine PA
Trenton, New Jersey, United States, 08618
Umdnj-Som
Voorhees, New Jersey, United States, 08084
United States, New Mexico
Lovelace Scientific Resources (Albuquerque)
Albuquerque, New Mexico, United States, 87108
Southwest Endocrinology Associates
Albuquerque, New Mexico, United States, 87109
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Physicians Associates of Park Place
Brooklyn, New York, United States, 11216
Diabetes Care & Information Center of New York
Flushing, New York, United States, 11365
M.E.R.I.
New York, New York, United States, 10023
Eastside Comprehensive Medical Center
New York, New York, United States, 10021
Physicians Clinical Research Service (PCRS) (SMO)
White Plains, New York, United States, 10604
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
Endocrine Research - Physician's East PA
Greenville, North Carolina, United States, 27834
United States, Ohio
Rapid Medical Research Inc
Cleveland, Ohio, United States, 44122
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, United States, 44060
United States, Oregon
New Hope Research of Oregon
Portland, Oregon, United States, 97219
United States, Pennsylvania
Buckingham Family Medicine
Doyleston, Pennsylvania, United States, 18912
Bucks County Clinical Research
Morrisville, Pennsylvania, United States, 19067
United States, South Carolina
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615
United States, Texas
Texas Familicare Clinical Research
Colleyville, Texas, United States, 76034
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
Houston Medical Research Associates
Houston, Texas, United States, 77030
North Texas Medical Research
Plano, Texas, United States, 75093
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States, 78229
Scott & White Hospital and Clinic
Temple, Texas, United States, 76508
McLennan County Medical Education and Research Foundation
Waco, Texas, United States, 76707
United States, Utah
Magna Center for Family Medicine
Magna, Utah, United States, 84044
Southeastern PA Med Inst LLC (SMO)
Salt Lake City, Utah, United States, 84107
Radiant Research Salt Lake City
Salt Lake City, Utah, United States, 84107
Davis Family Practice
Salt Lake City, Utah, United States, 84041
Granger Medical Clinic
West Valley City, Utah, United States, 84120
United States, Virginia
Hampton Roads Center for Clinical Research Inc
Norfolk, Virginia, United States, 23502
United States, Washington
Rainier Clinical Research Center Inc
Renton, Washington, United States, 98055
Clinical Research Department Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
Canada, Ontario
Finchlea Medical Group
Brampton, Ontario, Canada, L6T 3J1
Courtice Health Centre
Courtice, Ontario, Ontario, Canada, L1E 3C3
Parkwood Hospital
London, Ontario, Canada, N6C 5J1
Quest Clinical Trials
Markham, Ontario, Canada, L6B 1A1
The London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada, N7T 4X3
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada, N7T 4X3
Lifestyle Metabolism Center
Thornhill, Ontario, Canada, L4J 8L7
Lifestyle Metabolism Center (600-118 Eglinton Ave W)
Toronto, Ontario, Canada, M4R 2G4
Albany Medical Center
Toronto, Ontario, Canada, M4K 1N5
Manna Research
Toronto, Ontario, Canada, M9W 4L6
Czech Republic
Diabetologicka a interni ambulance
707 02 Ostrava-Kuncice, CZE, Czech Republic, 70702
Diabetologicka ambulance
Litomerice, CZE, Czech Republic, 41201
Surgery of Diabetology
Melnik, CZE, Czech Republic, 276 01
Internal Clinic
Ostrava - Poruba, CZE, Czech Republic, 708 52
Diabetologicka a interni ambulance
Ostrava 1, CZE, Czech Republic, 70200
Surgery of Diabetology Petrovice
Prague 15, CZE, Czech Republic, 109 00
FN Motol Interni Klinika
Praha 6, CZE, Czech Republic, 150 06
Poland
Oddzial Chorob Wewnetrznych
Bialystock, POL, Poland, 15-950
Klinika Endocrinologii Diabetologii I
Bialystock, POL, Poland, 15-276
Dzial Badan Klinicznych Malopoiskie
Krakow, POL, Poland, 30 510
III Oddzial Chorob Wewnetrznych Szpital
Krakow, POL, Poland, 31121
Endokrynologiczno Metaboliczne DIAB_ENDO_MET
Krakow, POL, Poland, 31-261
Oddzial Internistyczny Specjalistyczna
Lask, POL, Poland, 98-100
Oddzial Diabetologiczny Centrum
Lodz, POL, Poland, 93-338
Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, POL, Poland, 90 153
Oddzial Wewnetrzny B
Lodz, POL, Poland, 092-003
Spzital Kolejowy imm Wlodzimierza Roeflera
Pruszkow, POL, Poland, 05-800
ZPZOZ w Otwocku Szpital Miejski
Warsaw, POL, Poland, 05-400
Katedra i Klinika Gastroentereologii i
Warsaw, POL, Poland, 02-097
Oddzial Chorob Wewnetznych i Diabetologii
Warsaw, POL, Poland, 02-507
Klinika Medycyny Rodzinnej i Chorob
Warszawa, POL, Poland, 00-416
Russian Federation
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, Russian Federation, 650061
Kemerovo State Medical Academy of Ministry of Health
Kemerovo, RUS, Russian Federation, 650061
Russian State Medical University Central Clinical Hospital Russian Science Academy
Moscow, RUS, Russian Federation, 117593
Moscow State Medical-Stomatological University City Clinical Hospital # 23
Moscow, RUS, Russian Federation
Municipal Clinical Hospital #13
Moscow, RUS, Russian Federation, 150062
Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
Moscow, RUS, Russian Federation, 117036
Russian State Medical University City Hospital # 4
Moscow, RUS, Russian Federation, 113093
NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
Moscow, RUS, Russian Federation, 129110
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
Moscow, RUS, Russian Federation, 127644
RAAMS Endocrinology and Diabetology Department
Moscow, RUS, Russian Federation, 125315
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
Moscow, RUS, Russian Federation, 105229
NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
Moscow, RUS, Russian Federation, 115478
Ryazan State Medical University na academician IP Pavlov
Ryazan, RUS, Russian Federation, 390026
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
Smolensk, RUS, Russian Federation, 214018
Pavlov State Medical Univ of St Petersburg
St Petersburg, RUS, Russian Federation, 197022
Krestovsky Island Medical Institute
St Petersburg, RUS, Russian Federation, 107110
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
St Petersburg, RUS, Russian Federation, 193012
Central Medical Sanitary Unit #122
St Petersburg, RUS, Russian Federation, 194291
St Petersburg Medical Academy St Elizabeth Hospital
St Petersburg, RUS, Russian Federation, 195257
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
St. Petersburg, RUS, Russian Federation, 194354
NHI Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, Russian Federation, 150062
Clinical Pharm Dept of Yaroslavl Clin Hospital
Yaroslavl, RUS, Russian Federation, 150003
Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, Russian Federation, 150062
MHI Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, Russian Federation, 150003
Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
Moscow, Russian Federation, 105077
Spain
Fundacio Sarda Farriol
Barcelona, ESP, Spain, 08017
Hospital 12 de Octubre Consultas Extremas - Endocrinologia
Madrid, ESP, Spain, 28041
Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion
Madrid, ESP, Spain, 28040
Hospital Universitario de la Paz
Madrid, ESP, Spain, 28046
Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja
Sevilla, ESP, Spain, 41013
Sevilla, ESP, Spain, 41009
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Ukraine
Bukovinian State Medical University Dept of Clinical Immun
Chernivtcy, UKR, Ukraine, 58022
Dniepropetrovsh State Medical Academy
Dniepropetrovsk, UKR, Ukraine, 49023
Railway Clinical Hospital on Donetsk Station
Donetsk, UKR, Ukraine, 83114
Donetsk State Medical University
Donetsk, UKR, Ukraine, 83009
Donetsk State Medical University
Donetsk, UKR, Ukraine, 83003
V Danilevsky Inst of Endocrinology Pathology
Kharkiv, UKR, Ukraine, 61070
Ukr Scientifically Practical Centre of Endocrine Surgery
Kiev, UKR, Ukraine, 2175
Medical University at Kiev Center of Endocrinology and Metab
Kiev, UKR, Ukraine, 01004
Chair Family Med of National Med University
Kiev, UKR, Ukraine, 04050
Lugansk State Medical University Chair of Hosp Therapy #2
Lugansk, UKR, Ukraine, 91045
Lugansk State Medical University Chair of Therapy #1
Lugansk, UKR, Ukraine, 91045
Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University
Lvov, UKR, Ukraine, 79010
Odessa Reg. Clinical Hosp Outpatient Department
Odessa, UKR, Ukraine, 65025
Odessa State Med Dept of Family Med and Gen Practice
Odessa, UKR, Ukraine, 65039
Odessa State Medical University Dept of Gen Practice and Med Rehab
Odessa, UKR, Ukraine, 65009
Crimean State Medical University Dept of Therapy #1
Simferopol, UKR, Ukraine, 95017
Vinnitsa State Medical University
Vinnitsa, UKR, Ukraine, 21020
Outpatient Clinic of Family Physician "Rusanovka"
Kiev, Ukraine, 02147
Public Institution City Policlinic #20 Odessa
Odessa, Ukraine, 65114
United Kingdom
Barnsley Hospital
Barnsley, GBR, United Kingdom, S75 2EP
Kingthorne Group Practice
Doncaster, GBR, United Kingdom, DN3 2LX
Manny Cussins Centre
Leeds, GBR, United Kingdom, LS9 7TF
Royal liverpool University Hospital
Liverpool, GBR, United Kingdom, L7 8XP
Clinical Research Centre The Royal London Hospital
London, GBR, United Kingdom, E1 2AT
Medinova Research Mount Vernon Hospital
Middlesex, GBR, United Kingdom, HA6 2RN
Edith Cavel Hospital Diabetes Centre
Petersborough, GBR, United Kingdom, PE3 9GZ
Northern General Hospital
Sheffield, GBR, United Kingdom, S5 7AU
West Suffolk Hospital
Suffolk, GBR, United Kingdom, IP33 2QZ
Woolpit Medical Practice
Suffolk, GBR, United Kingdom, IP30 9QU
Birmingham Heartland Hospital
West Midlands, GBR, United Kingdom, B9 5SS
Bradford Hospital Dept of Diabetes & Endocrinology
West Yorkshire, GBR, United Kingdom, BD9 6RJ
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Anders Boss, MD, MFPM, Chief Medical Officer & Senior Vice President, MannKind Corporation
ClinicalTrials.gov Identifier: NCT00308737     History of Changes
Other Study ID Numbers: MKC-TI-030
Study First Received: March 28, 2006
Last Updated: October 1, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014