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Clinical Trial Details

Trial ID: L3323
Source ID: NCT00754624
Associated Drug: Technosphere® Insulin Inhalation Powder And Medtone™ Inhaler
Title: An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00754624/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Outcome Measures: Primary: Annual Rate of Change in FEV1 From Baseline to End of Study, Baseline to 48 months | Secondary: Annual Rate of Change in FVC From Baseline to End of Study, Baseline to 48 months|Annual Rate of Change in DLCo From Baseline to End of Study, Baseline to 48 months|Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months), Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months), Baseline to last measurement on study drug (maximum of 48 months|Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months), Change from Baseline to last study measurement on treatment (maximum of 48 months), Baseline to last study measurement on treatment (maximum of 48 months)|Change in Weight in kg From Baseline to End of Study, Baseline to last measurement on study drug (maximum of 48 months), Baseline to last measurement on study drug (maximum of 48 months)|High Resolution Computerized Tomography Scans of the Chest, End of study
Sponsor/Collaborators: Sponsor: Mannkind Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 229
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-05
Completion Date: 2008-10
Results First Posted: 2014-10-16
Last Update Posted: 2014-10-16
Locations: Dorothy L & James E Frank Diabetes Research Institute, San Mateo, California, 94401, United States|Sansum Medical Research Institute, Santa Barbara, California, 93105, United States|Alliance Medical Group of Greater Waterbury, Middlebury, Connecticut, 06762, United States|The Hospital of Central Connecticut, New Britain, Connecticut, 06050, United States|Soundview Research Associates, Norwalk, Connecticut, 06851, United States|University of Miami School of Medicine, Miami, Florida, 33136, United States|Oschner Clinic Foundation, New Orleans, Louisiana, 70121, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|Diabetes Care & Information Center of New York, Flushing, New York, 11365, United States|Diabetes Team Associated, New York, New York, 10016, United States|Endocrine Research - Physician's East PA, Greenville, North Carolina, 27834, United States|Your Diabetes Endocrine Nutrition Group, Mentor, Ohio, 44060, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States|Texas Diabetes Institute, San Antonio, Texas, 78207, United States|Diabetes & Glandular Disease Research Assoc PA, San Antonio, Texas, 78229, United States|Diabetes Care Center, Seattle, Washington, 98105, United States|MBAL "Pleven", Pleven, BGR, 5800, Bulgaria|SBALENG-Sofia Institute of Endocrinology, Sofia, BGR, 1303, Bulgaria|MBAL Alexandrovska Hospital, Sofia, BGR, 1431, Bulgaria|Military Medical Academy, Sofia, BGR, 1431, Bulgaria|Central Clinical Base, Sofia, BGR, 1606, Bulgaria|MBAL "Sweta Marina" - Varna, Varna, BGR, 5000, Bulgaria|II-nd MBAL, Sofia, 1202, Bulgaria|Military Medical Academy, Sofia, 1431, Bulgaria|University Hospital in Brno, Brno-Bohunice, CZE, 625 00, Czech Republic|Military Hospital in Brno, Brno, CZE, 636 00, Czech Republic|Hospital of "Milosrdnych brain", Brno, CZE, 639 00, Czech Republic|Surgery of Diabetology, Melnik, CZE, 276 01, Czech Republic|University Hospital of 3rd Faculty, Prague 10, CZE, 100 34, Czech Republic|Diabetologicka oridnace, Prague 2, CZE, 120 00, Czech Republic|General Hospital in Prague and 1st Faculty of Medicine of, Prague 2, CZE, 120 00, Czech Republic|Institute for Clinical and Exp Medicine, Prague 4, CZE, 140 21, Czech Republic|University Hospital Na Bulovce, Prague 8, CZE, 180 81, Czech Republic|Surgery of Diabetology Petrovice, Prague, CZE, 109 00, Czech Republic|Surgery of Diabetology Stodulky, Prague, CZE, 155 00, Czech Republic|Surgery of Diabetology Slany, Slany, CZE, 274 01, Czech Republic|Surgery of Diabetology Zastavka, Zastavka, Brno, CZE, 664 84, Czech Republic|Surgery of Diabetology (Brno), Brno, 612 00, Czech Republic|ikfe Berlin, Berlin, DEU, D 10115, Germany
URL: https://clinicaltrials.gov/show/NCT00754624

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress