Trials / Completed
CompletedNCT00875108
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Biodel · Industry
- Sex
- All
- Age
- 30 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Follow-on study to the VIAject™-08J study to evaluate the long-term safety and efficacy of VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 2 diabetes mellitus. The VIAject™-08J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 2 diabetes mellitus with VIAject™ insulin or regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VIAject™ | Subcutaneous injection 25 IU/mL |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2009-04-03
- Last updated
- 2015-07-29
Source: ClinicalTrials.gov record NCT00875108. Inclusion in this directory is not an endorsement.