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Clinical Trial Details

Trial ID: L7114
Source ID: NCT01451398
Associated Drug: Technosphere® Insulin
Title: Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01451398/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Technosphere® Insulin|DRUG: Technosphere Powder
Outcome Measures: Primary: Change From Baseline to Week 24 in HbA1c, Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24, Baseline to Week 24 | Secondary: Proportion of Responders Achieving HbA1c <= 7.0%, Efficacy as measured in proportion of subjects achieving HbA1c \< or = to 7.0%, Week 24|Proportion of Responders Achieving HbA1c <= 6.5%, Efficacy as measured in proportion of subjects achieving HbA1c \< or = to 6.5% at Week 24, Week 24|FPG Change From Baseline to Week 24, Efficacy as measured by mean change in fasting plasma glucose (FPG), Baseline to Week 24|Proportion of Subjects Requiring Rescue Therapy, Baseline to Week 24|Time to Rescue, Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment, Baseline to Week 24|FEV1 Change From Baseline to Week 24, Forced Expiratory Volume in 1 second - change from baseline to week 24, Baseline to Week 24|Incidence of Total Hypoglycemia, Hypoglycemia, defined as blood glucose \<= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates., Baseline to Week 24|Incidence of Severe Hypoglycemia, Severe Hypoglycemia defined as: Requiring 3rd party assistance., Baseline to Week 24|Total Hypoglycemia Event Rate, Number of Hypoglycemic Events/Total Subject Exposure Time (in months), Baseline to Week 24|Severe Hypoglycemia Event Rate, Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months), Baseline to Week 24|Mean 7-point Glucose Baseline Values, Mean 7-point self-monitored glucose at baseline, Baseline|Mean 7-point Glucose Week 24 Values, Mean 7-point self-monitored blood glucose at Week 24, Week 24|Change in Body Weight From Baseline to Week 24, Change in body weight from Baseline to Week 24, Baseline to Week 24
Sponsor/Collaborators: Sponsor: Mannkind Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 353
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-11
Completion Date: 2013-07
Results First Posted: 2014-10-17
Last Update Posted: 2014-10-17
Locations: Anaheim, California, 92807, United States|Huntington Beach, California, 92648, United States|Laguna Hills, California, 92653, United States|Long Beach, California, 90806, United States|Los Angeles, California, 90036, United States|Los Gatos, California, 95032, United States|Tustin, California, 92780, United States|West Hills, California, 91307, United States|Hialeah, Florida, 33012, United States|Hollywood, Florida, 33021, United States|Miami, Florida, 33156, United States|Miami, Florida, 33173, United States|New Port Richey, Florida, 34652, United States|North Miami Beach, Florida, 33179, United States|Pembroke Pines, Florida, 33026, United States|Pinellas Park, Florida, 33781, United States|West Palm Beach, Florida, 33401, United States|Atlanta, Georgia, 30308, United States|Atlanta, Georgia, 30318, United States|Dunwoody, Georgia, 30338, United States|Lawrenceville, Georgia, 30045, United States|Roswell, Georgia, 30076, United States|Chicago, Illinois, 60607, United States|Baton Rouge, Louisiana, 70808, United States|Edina, Minnesota, 55435, United States|Jefferson City, Missouri, 65109, United States|St Peters, Missouri, 63376, United States|St. Louis, Missouri, 63110, United States|St. Louis, Missouri, 63117, United States|Omaha, Nebraska, 68114, United States|Omaha, Nebraska, 68131, United States|Clifton, New Jersey, 07012, United States|Hackensack, New Jersey, 07601, United States|Paramus, New Jersey, 07652, United States|Flushing, New York, 11365, United States|New Hyde, New York, 11042, United States|Greenville, North Carolina, 27834, United States|Perrysburg, Ohio, 43551, United States|Portland, Oregon, 97239, United States|Greer, South Carolina, 29651, United States|Memphis, Tennessee, 38119, United States|Arlington, Texas, 76014, United States|Dallas, Texas, 75230, United States|Dallas, Texas, 75246, United States|Houston, Texas, 77095, United States|San Antonio, Texas, 78229, United States|San Antonio, Texas, 78249, United States|Magna, Utah, 84044, United States|Renton, Washington, 98057, United States|Wenatchee, Washington, 98801, United States|Porto Alegre, 90035, Brazil|Sao Paulo, 01244, Brazil|Kemerovo, 650066, Russian Federation|Leningrad Region, Russian Federation|Moscow, 105120, Russian Federation|Moscow, 117036, Russian Federation|Moscow, 119435, Russian Federation|Moscow, 119991, Russian Federation|Moscow, 121374, Russian Federation|Moscow, 129128, Russian Federation|Moscow, 143420, Russian Federation|Petrozavodsk, 185019, Russian Federation|Smolensk, 214018, Russian Federation|St. Petersburg, 194044, Russian Federation|St. Petersburg, 194354, Russian Federation|St. Petersburg, 195257, Russian Federation|St. Petersburg, 196601, Russian Federation|St. Petersburg, 198013, Russian Federation|Yaroslavl, 150003, Russian Federation|Yaroslavl, 150023, Russian Federation|Kharkiv, UKR, 61070, Ukraine|Kiev, UKR, 04053, Ukraine|Kyiv, UKR, 02175, Ukraine|Odesa, UKR, 65039, Ukraine|Vinnytsya, UKR, 21010, Ukraine|Kiev, 04114, Ukraine
URL: https://clinicaltrials.gov/show/NCT01451398

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress