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
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- The frequency of occurrence of hypoglycemia measured quarterly over one year. [ Time Frame: 18 months for most subjects ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 18 months for most subjects ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Subcutaneous injection 25 IU/mL