Full Text View
Tabular View
No Study Results Posted
Related Studies
An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 1 Diabetes Mellitus
This study is ongoing, but not recruiting participants.
First Received: April 2, 2009   No Changes Posted
Sponsored by: Biodel
Information provided by: Biodel
ClinicalTrials.gov Identifier: NCT00875459
  Purpose

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
Diabetes Mellitus
Drug: VIAject™
Phase III

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • The frequency of occurrence of hypoglycemia measured quarterly over one year. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Estimated Enrollment: 222
Study Start Date: April 2007
Arms Assigned Interventions
VIAject™: Experimental
Single injection
Drug: VIAject™
Subcutaneous injection 25 IU/mL

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Completed the VIAject™-06J protocol
  2. Informed consent must be obtained in writing for all subjects

Exclusion Criteria:

  1. History of frequent severe hypoglycemia within the prior six months which prevent study participation at the discretion of the investigator
  2. History of known hypersensitivity to any of the components in the study medication
  3. Progressive disease likely to prove fatal
  4. Known significant hepatic disease or serum AST or ALT values > 3 X upper limit of normal or bilirubin levels > 1.5 X upper limit of normal
  5. Severe complications of diabetes mellitus including a history or finding of Stage III or IV diabetic retinopathy (see Appendix B), proteinuria > 2+ by urine dipstick, serum creatinine of >1.8 mg/dl for males or >1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease, which has resulted in amputation or recent onset of chronic foot ulcers or claudication, or the recent, clinically documented loss a pedal pulse.
  6. History of moderate to severe ketoacidosis within the 3 months preceding screening for the study
  7. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
  8. Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
  9. A sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy or a woman intending to become pregnant during the study
  10. Abnormal ECG, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
  11. A history of lack of compliance with medical instructions, recent drug or alcohol abuse, or other reasons which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009