Clinical Trial Details
| Trial ID: | L6008 |
| Source ID: | NCT00511732 |
| Associated Drug: | Technosphere Insulin |
| Title: | 18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Technosphere Insulin|DRUG: Technosphere Placebo |
| Outcome Measures: | Primary: HbA1c change from baseline (week 6) to end of treatment (week 17), measured from week 6 (baseline) to week 17|Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline., Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after TI administration, at weeks 4, 6, 11 and 17|Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline), Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after Technosphere Placebo administration, at weeks 4, 6, 11 and 17 | Secondary: Fasting blood glucose concentration compared to week 6 (baseline), at weeks 4, 6, 11 and 17|Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations, 18 weeks |
| Sponsor/Collaborators: | Sponsor: Mannkind Corporation |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 227 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2004-06 |
| Completion Date: | 2007-08 |
| Results First Posted: | |
| Last Update Posted: | 2012-04-30 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00511732 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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