Type 1 Diabetes MellitusPhase 3NCT01110746
To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
A Phase 3 study testing Viaject 7 and LISPRO in people with Type 1 Diabetes Mellitus, run by Biodel at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Viaject 7 and LISPRO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females diagnosed with type 1 diabetes mellitus for at least 6 months
- Current usage of subcutaneous insulin pump treatment with one of the following pumps:
- Medtronic Paradigm®
- Animas®
- OmniPod®
- ACCU-CHEK Spirit®
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- Age 18-75 years
- HbA1c of 6.0 - 9.0% at screening visit.
- Willingness to attend 9 clinic visits.
Who cannot join
- Pregnancy or Lactation
- Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
- Anemia
- Congestive heart failure.
- Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device.
- Active coronary artery disease or heart procedure within the past 4 months.
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- Active foot ulceration.
- Severe peripheral arterial disease.
- Stroke within the past 6 months.
- Active alcohol abuse, substance abuse, or severe mental illness.
- Active cancer, except basal cell or squamous cell skin cancers.
- Major surgical operation within 30 days prior to screening.
- Seizure disorder (epilepsy).
- Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
- Currently use of corticosteroids.
- History of major non-compliance.
- Use of an investigational drug within 30 days prior to screening.
- Bleeding disorder, treatment with warfarin, or low platelet count.
- Any insulin allergy
- Current complaints of major infusion site problems with commercially- available insulin preparations, such as frequent occurrence of infections, marked swelling or marked erythema.
- History of gastroparesis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University/Legacy Health System
Portland, Oregon, 97232
About this study
Official title: A Double-blind Study of the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Viaject 7, LISPRO
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viaject 7Drug
100IU/mL administered subcutaneously
LISPRODrug
100IU/mL administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | Single Injection Receives: Drug: Viaject 7 |
| Formulation B | Experimental | Single Injection Receives: Drug: LISPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 hour incremental area under the glucose curve after a standardized high glycemic index meal.
Measured: 3 hours
Secondary outcomes (1)
Draize scores at insulin infusion site at 24 hour and 72 hour follow-up visits, frequency of discomfort with insulin infusion, and severity of discomfort with insulin infusion (ratings of mild, moderate, or severe).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2010
- Study completionJun 2010
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110746
- Sponsor's protocol ID
- VIAject -032J
- Status last verified
- Jul 2015
- First submitted
- 13 Apr 2010
- 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
- A Double-blind Study of the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT01110746
- Acronym / sponsor ID
- VIAject -032J
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Apr 2010 (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 evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: Viaject 7Single Injection |
| Formulation B | Experimental | Drug: LISPROSingle Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females diagnosed with type 1 diabetes mellitus for at least 6 months
- Current usage of subcutaneous insulin pump treatment with one of the following pumps:
- Age 18-75 years
- HbA1c of 6.0 - 9.0% at screening visit.
- Willingness to attend 9 clinic visits.
Key exclusion criteria (21 listed)
- Pregnancy or Lactation
- Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
- Anemia
- Congestive heart failure.
- Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device.
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 7100IU/mL administered subcutaneously | Drug | Formulation A |
| LISPRO100IU/mL administered subcutaneously | Drug | Formulation B |
Primary outcome
3 hour incremental area under the glucose curve after a standardized high glycemic index meal.
Time frame: 3 hours
1 secondary outcome
Draize scores at insulin infusion site at 24 hour and 72 hour follow-up visits, frequency of discomfort with insulin infusion, and severity of discomfort with insulin infusion (ratings of mild, moderate, or severe).
Time frame: 72 hours
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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viaject 7 and LISPRO in people with Type 1 Diabetes Mellitus, run by Biodel at 1 site in United States.
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 9 inclusion and 21 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
3 hour incremental area under the glucose curve after a standardized high glycemic index meal. (time frame: 3 hours). 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.