Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
This study has been completed.
Sponsor:
Mannkind Corporation
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00308737
First received: March 28, 2006
Last updated: October 1, 2009
Last verified: October 2009
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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:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin human
U.S. FDA Resources
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
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| 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 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013