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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00875459
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: VIAject™ Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: VIAject™
Single injection
Drug: VIAject™
Subcutaneous injection 25 IU/mL

Primary Outcome Measures :
  1. The frequency of occurrence of hypoglycemia measured quarterly over one year. [ Time Frame: 18 months for most subjects ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Biodel Identifier: NCT00875459     History of Changes
Other Study ID Numbers: VIAject™-07J
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs