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

NCT00875108 | Completed Phase 3

• 1 other identifier: VIAject™-09J
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The frequency of occurrence of hypoglycemia measured quarterly over one year.

  18 months for most subjects

Secondary Outcomes (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.

  18 months for most subjects

Study Arms (1)

VIAject™

EXPERIMENTAL

Single injection

Drug: VIAject™

Interventions

VIAject™ DRUG

Subcutaneous injection 25 IU/mL

VIAject™

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed the VIAject™-08J protocol
• Informed consent must be obtained in writing for all subjects.

You may not qualify if:

• History of frequent severe hypoglycemia within the prior six months which prevent study participation at the discretion of the investigator
• History of known hypersensitivity to any of the components in the study medication
• Progressive disease likely to prove fatal
• 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
• 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.
• History of moderate to severe ketoacidosis within the 3 months preceding screening for the study
• Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
• Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
• 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
• 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
• 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

Sponsors & Collaborators

• Biodel: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: July 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 29, 2015

Record last verified: 2015-07