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Sponsored by: |
Biodel |
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Information provided by: | Biodel |
ClinicalTrials.gov Identifier: | NCT00875459 |
Follow-on study to the VIAject™ 06J study to evaluate the long-term safety and efficacy of VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 1 diabetes mellitus.
The VIAject™ 06J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: VIAject™ |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 222 |
Study Start Date: | April 2007 |
Arms | Assigned Interventions |
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VIAject™: Experimental
Single injection
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Drug: VIAject™
Subcutaneous injection 25 IU/mL
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Biodel |
Study ID Numbers: | VIAject™-07J |
Study First Received: | April 2, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00875459 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; India: Drugs Controller General of India |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |