Type 1 Diabetes MellitusPhase 3NCT00542724
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 1 Diabetes Mellitus
A Phase 3 study testing VIAject™ and Regular Human Insulin in people with Type 1 Diabetes Mellitus, run by Biodel.
Trial summary
The purpose of this study is to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human insulin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- VIAject™ and Regular Human Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jul 2008
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with type 1 diabetes must present with the following:
- Established diagnosis of type 1 diabetes for more than 1 year.
- HbA1c values of not more than 10.5%.
- Three months on a stable insulin regimen that meets the current standard of care and that includes at least two daily insulin injections.
- Age: 18 to 70 years.
- Body Mass Index: 18 - 38 Kg/m2.
Who cannot join
- Patients presenting with any of the following will not be included in the study:
- Type 2 diabetes mellitus as determined by the investigator.
- History of frequent severe hypoglycemia within the prior six months.
- C-peptide > 1.0 ng/ml unless there is a documented history of ketoacidosis or a documented history of a positive anti GAD test.
- History of known hypersensitivity to any of the components in the study medication.
- History of severe or multiple allergies.
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- Treatment with investigational diabetes drug in the last 3 months or treatment with any other investigational drug in the last 30 days before study entry.
- Current short-term treatment with systemic oral, injected, or inhaled corticosteroids. (inhaled corticosteroids may be allowed when the treatment is long-term).
- Progressive disease likely to prove fatal.
- History of malignancy within the past 5 years except for basal cell epithelioma.
- 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.
- Severe complications of diabetes mellitus including a history or finding of Stage III or IV diabetic retinopathy, 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 an amputation, chronic foot ulcers claudication or absent pedal pulses.
- Known history of autonomic neuropathy.
- 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 patient safety or protocol compliance.
- Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator.
- Blood donation within the last 30 days.
- A woman who is breast feeding.
- Pregnant women or women intending to become pregnant during the study.
- A sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy.
- Abnormal ECG, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the patient 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 patient in the study to be inappropriate or unsafe.
- Current significant diseases of the adrenal gland, pituitary gland or thyroid at the discretion of the investigator.
- Glomerular Filtration Rate < 40 ml/min.
About this study
The purpose of this study is to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human insulin.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- VIAject™, Regular Human Insulin
- Keywords
- Insulin, Diabetes Mellitus type I, Juvenile diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIAject™Drug
Dosage as individually required
Regular Human InsulinDrug
Dosage as individually required
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | VIAject™ Receives: Drug: VIAject™ |
| B | Active comparator | Regular Human Insulin Receives: Drug: Regular Human Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
To evaluate the mean changes in hemoglobin A1c (HbA1c) from baseline to the end of the study in subjects with type 1 diabetes after treatment for 6 months with Viaject in comparison to the mean changes in HbA1c from baseline to end of study in subjects treated with regular human insulin (RHI).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startSep 2006
- Primary completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David C Klonoff, M.D., F.A.C.P., Principal investigator, Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542724
- Sponsor's protocol ID
- VIAject™-06J
- Status last verified
- Jul 2015
- First submitted
- 5 Oct 2007
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00542724
- Acronym / sponsor ID
- VIAject™-06J
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Insulin, Diabetes Mellitus type I, Juvenile diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jul 2008 (actual)
- First posted
- 11 Oct 2007 (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.
The purpose of this study is to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: VIAject™VIAject™ |
| B | Active comparator | Drug: Regular Human InsulinRegular Human Insulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Established diagnosis of type 1 diabetes for more than 1 year.
- HbA1c values of not more than 10.5%.
- Three months on a stable insulin regimen that meets the current standard of care and that includes at least two daily insulin injections.
- Age: 18 to 70 years.
- Body Mass Index: 18 - 38 Kg/m2.
Key exclusion criteria (24 listed)
- Type 2 diabetes mellitus as determined by the investigator.
- History of frequent severe hypoglycemia within the prior six months.
- C-peptide > 1.0 ng/ml unless there is a documented history of ketoacidosis or a documented history of a positive anti GAD test.
- History of known hypersensitivity to any of the components in the study medication.
- History of severe or multiple allergies.
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™Dosage as individually required | Drug | A |
| Regular Human InsulinDosage as individually required | Drug | B |
Primary outcome
Change in HbA1c
Time frame: 6 months
To evaluate the mean changes in hemoglobin A1c (HbA1c) from baseline to the end of the study in subjects with type 1 diabetes after treatment for 6 months with Viaject in comparison to the mean changes in HbA1c from baseline to end of study in subjects treated with regular human insulin (RHI).
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 3 Aug 2015.
- Type 1 Diabetes studyLink provided by the sponsor.
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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.
David C Klonoff, M.D., F.A.C.P. principal investigator
Diabetes Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VIAject™ and Regular Human Insulin in people with Type 1 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 6 inclusion and 24 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 3 Aug 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?
Change in HbA1c (time frame: 6 months). 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 3 Aug 2015.