An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 2 Diabetes Mellitus

Follow-on study to the VIAject™-08J study to evaluate the long-term safety and efficacy of VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 2 diabetes mellitus.

The VIAject™-08J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 2 diabetes mellitus with VIAject™ insulin or regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: VIAject™

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Completed the VIAject™-08J 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 times the upper limit of normal or bilirubin levels > 1.5 times the 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIAject™; Single injection	Drug: VIAject™; Subcutaneous injection 25 IU/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The frequency of occurrence of hypoglycemia measured quarterly over one year.	18 months for most subjects

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biodel

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: April 2, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimate): April 3, 2009

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: VIAject™-09J