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| Sponsor: | Mannkind Corporation |
|---|---|
| Information provided by: | Mannkind Corporation |
| ClinicalTrials.gov Identifier: | NCT00332826 |
Purpose
The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma |
Drug: Technosphere Insulin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment |
| Official Title: | A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma |
| Estimated Enrollment: | 193 |
| Study Start Date: | June 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Research Center | |
| Phoenix, Arizona, United States, 85023 | |
| Northwest Medical Center | |
| Phoenix, Arizona, United States, 85029 | |
| Premiere Pharmaceutical Research LLC | |
| Tempe, Arizona, United States, 85282 | |
| Canyon Internal Medicine | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Family Medical Center | |
| Foothill Ranch, California, United States, 92610 | |
| Golden Pine Clinical Research | |
| Long Beach, California, United States, 90807 | |
| Associated Pharmaceutical Research Center Inc | |
| Buena Park, California, United States, 90620 | |
| Keck USC School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| Health Care Partners Medical Group | |
| Long Beach, California, United States, 90806 | |
| United States, Georgia | |
| Pinaccle Trials Inc (SMO) | |
| Atlanta, Georgia, United States, 30329 | |
| Pinaccle Trials Inc (SMO) | |
| Atlanta, Georgia, United States, 30329 | |
| Executive Health and Research Associates Inc | |
| Atlanta, Georgia, United States, 30342 | |
| Atlanta Pharmaceutical Research Center | |
| Dunwoody, Georgia, United States, 30338 | |
| Southeastern Endocrine & Diabetes | |
| Roswell, Georgia, United States, 30076 | |
| United States, Illinois | |
| Cedar-Crosse Research Center | |
| Chicago, Illinois, United States, 60607 | |
| United States, Maryland | |
| Franklin Square Hospital | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Missouri | |
| MedEx Healthcare Research Inc(009) | |
| St Louis, Missouri, United States, 63117 | |
| Healthcare Research | |
| Florissant, Missouri, United States, 63031 | |
| United States, Montana | |
| Billings Clinic Research Division | |
| Billings, Montana, United States, 59101 | |
| United States, New Jersey | |
| Hopewell Valley Family Medicine PA | |
| Trenton, New Jersey, United States, 08618 | |
| Your Doctors Care | |
| Hillsborough, New Jersey, United States, 08844 | |
| United States, New York | |
| Eastside Comprehensive Medical Center | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Carolinas Research | |
| Concord, North Carolina, United States, 28025 | |
| United States, Ohio | |
| Cleveland Clinic Dept of Endocrinology | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| Diabetes & Glandular Disease Research Assoc PA | |
| San Antonio, Texas, United States, 78229 | |
| McLennan County Medical Education and Research Foundation | |
| Waco, Texas, United States, 76707 | |
| Argentina | |
| Ins De Inv Cardiovascular La Plata | |
| La Plata, Argentina | |
| DIM (Clinica Privada) | |
| Buenos Aires, Argentina, 1704 | |
| Brazil | |
| Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda | |
| Rio de Janeiro, Brazil, 22271-100 | |
| CPClin-Centro de Pesquisas Clinicas | |
| Sao Paulo, Brazil, 01244-030 | |
| Irmandade da Santa Casa de Misericordia de Porto Alegre | |
| Porto Alegre, Brazil, 90035-070 | |
| Hospital Nossa Senhora da Conceicao | |
| Porto Alegre, Brazil, 91350-200 | |
| Hospital Sao Lucas - PUCRS (Fritscher) | |
| Porto Alegre, Brazil, 90610-000 | |
| Clinica de Endocrinologia | |
| Sao Paulo, Brazil, 01323-001 | |
| Brazil, Rio Grande do Sul | |
| Hospital de Clinicas de Porto Alegre | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035-903 | |
| Canada, Ontario | |
| Windsor Professional Research | |
| Windsor, Ontario, Canada, N8X 3V6 | |
| Finchlea Medical Group | |
| Brampton, Ontario, Canada, L6T 3J1 | |
| Courtice Health Centre | |
| Courtice, Ontario, Canada, L1E 3C3 | |
| Parkwood Hospital | |
| London, Ontario, Canada, N6C 5J1 | |
| The London Road Diagnostic Clinic and Medical Centre | |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Albany Medical Center | |
| Toronto, Ontario, Canada, M4K 1N5 | |
| Czech Republic | |
| I InternÃ- klinika | |
| Ostrava, Czech Republic, 728 80 | |
| InternÃ- a diabetologická Outpatient | |
| Ostrava, Czech Republic, 70900 | |
| Czech Republic, CZE | |
| Surgery of Diabetology | |
| Melnik, CZE, Czech Republic, 276 01 | |
| Diabetologicka Outpatient Surgery of Diabetology | |
| Slany, CZE, Czech Republic, 274 01 | |
| Interni oddeleni nemocnice Na Homolce | |
| Praha 5, CZE, Czech Republic, 15031 | |
| Mexico | |
| Nuevo Sanatorio Durango | |
| Delegacion Cuauhtemoc, Mexico, 6700 | |
| Hospital Angeles de las Lomas | |
| Huixquilucan, Mexico, 52760 | |
| Mexico, DF | |
| Hospital Angeles Mocel | |
| Mexico City, DF, Mexico, 06726 | |
| Mexico, MX | |
| Mexican Institute of Clinical Research | |
| Mexico City, MX, Mexico, 06700 | |
| Poland | |
| Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego | |
| Lodz, Poland, 90-153 | |
| Poland, POL | |
| NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny | |
| Bialystok, POL, Poland, 15-435 | |
| Klinika Endocrinologii Diabetologii I | |
| Bialystock, POL, Poland, 15-276 | |
| III Oddzial Chorob Wewnetrznych Szpital | |
| Krakow, POL, Poland, 31121 | |
| Dzial Badan Klinicznych Malopoiskie | |
| Krakow, POL, Poland, 30 510 | |
| Poland, Zgierz | |
| Oddzial Chorob Wewnetrznych Wojewodzki | |
| Lodz, Zgierz, Poland, 95-100 | |
| Russian Federation | |
| City Clinical Hospital # 61 | |
| Moscow, Russian Federation, 119 048 | |
| Central Clinical Hospital of Russian Science Academy | |
| Moscow, Russian Federation, 117 593 | |
| Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD | |
| Moscow, Russian Federation, 105077 | |
| St Petersburg Medical Academy (Ilkovich) | |
| St Petersburg, Russian Federation | |
| City Clinical Hospital #64 Center of Applied Clinical Paharmacology Friendship University | |
| Moscow, Russian Federation, 117 198 | |
| Russian Scientific Center of Restoration Medicine & Balneology | |
| Moscow, Russian Federation, 121069 | |
| Russian Federation, RUS | |
| Smolensk Medical Academy Smolensk Regional Clinical Hospital | |
| Smolensk, RUS, Russian Federation, 214018 | |
| Yaroslavl Municipal Health Care Institution Clinical Hospital for Emergency Care na NV Soloviev | |
| Yaroslavl, RUS, Russian Federation, 150003 | |
| Central Medical Sanitary Unit #122 | |
| St Petersburg, RUS, Russian Federation, 194291 | |
| NI Principal Military Clinical Hospital n a academician N.N. Burdenko | |
| Moscow, RUS, Russian Federation, 105229 | |
| Moscow State Medico-Stomatological University City Hospital # 23 | |
| Moscow, RUS, Russian Federation, 109240 | |
| City Hospital # 2 Endocrinology Department | |
| St. Petersburg, RUS, Russian Federation, 194354 | |
| NHI Kemerovo Regional Clinical Hospital | |
| Kemerovo, RUS, Russian Federation, 650061 | |
| Spain | |
| Hospital 2 de Maig | |
| Barcelona, Spain, 30108025 | |
| Ukraine, UKR | |
| Chair Family Med of National Med University | |
| Kiev, UKR, Ukraine, 04050 | |
| Railway Clinical Hospital on Donetsk Station | |
| Donetsk, UKR, Ukraine, 83114 | |
| Donetsk State Medical University | |
| Donetsk, UKR, Ukraine, 83003 | |
| Donetsk State Medical University | |
| Donetsk, UKR, Ukraine, 83009 | |
| Institute of Endocrinology and Metabolism | |
| Kiev, UKR, Ukraine, 04114 | |
| United Kingdom | |
| Addenbrooke's Hospital Department of Medicine | |
| Cambridge, United Kingdom, CB2 2QQ | |
| United Kingdom, GBR | |
| Birmingham Heartland Hospital | |
| West Midlands, GBR, United Kingdom, B9 5SS | |
| Northern General Hospital | |
| Sheffield, GBR, United Kingdom, S5 7AU | |
| Clinical Research Centre The Royal London Hospital | |
| London, GBR, United Kingdom, E1 2AT | |
More Information
| Study ID Numbers: | MKC-TI-105 |
| Study First Received: | June 1, 2006 |
| Last Updated: | October 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00332826 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Inhaled insulin Diabetes Type I and II with Asthma |
|
Autoimmune Diseases Metabolic Diseases Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Asthma Pharmacologic Actions Insulin |
Lung Diseases, Obstructive Hypersensitivity Hypoglycemic Agents Diabetes Mellitus, Type 1 Respiratory Tract Diseases Lung Diseases Diabetes Mellitus, Type 2 Hypersensitivity, Immediate Glucose Metabolism Disorders Respiratory Hypersensitivity |