Clinical Trial Details
| Trial ID: | L4806 |
| Source ID: | NCT00875108 |
| Associated Drug: | Viaject™ |
| Title: | An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus |
| Interventions: | DRUG: VIAject™ |
| Outcome Measures: | Primary: The frequency of occurrence of hypoglycemia measured quarterly over one year., 18 months for most subjects | Secondary: Changes in total daily:Prandial insulin dose, insulin dose, body weight, insulin antibody titers, the effects of insulin antibodies on glycemic control, individual and group mean %HbA1C measured quarterly and over one year., 18 months for most subjects |
| Sponsor/Collaborators: | Sponsor: Biodel |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 116 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2007-07 |
| Completion Date: | 2010-01 |
| Results First Posted: | |
| Last Update Posted: | 2015-07-29 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00875108 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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