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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT00875459
First received: April 2, 2009
Last updated: October 4, 2011
Last verified: April 2010

April 2, 2009
October 4, 2011
April 2007
February 2010   (final data collection date for primary outcome measure)
The frequency of occurrence of hypoglycemia measured quarterly over one year. [ Time Frame: 18 months for most subjects ] [ Designated as safety issue: No ]
The frequency of occurrence of hypoglycemia measured quarterly over one year. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00875459 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
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
Not Provided

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: VIAject™
Subcutaneous injection 25 IU/mL
Experimental: VIAject™
Single injection
Intervention: Drug: VIAject™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00875459
VIAject™-07J
No
Biodel
Biodel
Not Provided
Not Provided
Biodel
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP