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

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875459
• Other study ID #: VIAject™-07J
• Status: Completed
• Phase: Phase 3
• First received: April 2, 2009
• Last updated: July 28, 2015
• Start date: April 2007
• Est. completion date: February 2010

Study information

• Verified date: July 2015
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• VIAject™
Subcutaneous injection 25 IU/mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of occurrence of hypoglycemia measured quarterly over one year.		18 months for most subjects	No
Secondary	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.		18 months for most subjects	No