Diabetes MellitusPhase 3NCT00875108
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
A Phase 3 study testing VIAject™ in people with Diabetes Mellitus, run by Biodel.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- VIAject™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed the VIAject™-08J protocol
- Informed consent must be obtained in writing for all subjects.
Who cannot join
- 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
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- 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
About this study
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
- Being tested
- VIAject™
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIAject™Drug
Subcutaneous injection 25 IU/mL
| Study group | Role | What they receive |
|---|---|---|
| VIAject™ | Experimental | Single injection Receives: Drug: VIAject™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of occurrence of hypoglycemia measured quarterly over one year.
Measured: 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.
Measured: 18 months for most subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startJul 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875108
- Sponsor's protocol ID
- VIAject™-09J
- Status last verified
- Jul 2015
- First submitted
- 2 Apr 2009
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00875108
- Acronym / sponsor ID
- VIAject™-09J
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIAject™ | Experimental | Drug: VIAject™Single injection |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed the VIAject™-08J protocol
- Informed consent must be obtained in writing for all subjects.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIAject™Subcutaneous injection 25 IU/mL | Drug | VIAject™ |
Primary outcome
The frequency of occurrence of hypoglycemia measured quarterly over one year.
Time frame: 18 months for most subjects
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VIAject™ in people with Diabetes Mellitus, run by Biodel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of occurrence of hypoglycemia measured quarterly over one year. (time frame: 18 months for most subjects). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.