Type 2 DiabetesPhase 3NCT00849576
Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.
A Phase 3 study testing Regular Human Insulin, Insulin Lispro and Insulin VIAject™ (75%) in people with Type 2 Diabetes, run by Biodel at 1 site in Germany.
Trial summary
The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Regular Human Insulin, Insulin Lispro and Insulin VIAject™ (75%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Aug 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus according to the ADA criteria
- HbA1c between 6.5 % and 9.9 %
- Treatment with sulfonylurea and/or metformin in a stable dosage within the last 3 months
- Age between 40 and 75 years
- BMI < 40
Who cannot join
- Type 1 diabetes mellitus
- Pre-treatment with insulin within the last 6 months prior to screening
- Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
- Untreated hypertension stage II-III according to WHO criteria
- Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
- Total cholesterol > 300 mg/dl (anamnestically)
Show all 19Show fewer
- Major micro- or macrovascular complications as judged by the investigator
- Tobacco use within the last 6 months prior to screening
- Drugs with major impact on endothelial function like nitrates etc.
- History of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance
- History of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dL in women and > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- Pregnancy or breast feeding
- Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
- Lack of compliance or other similar reason that at the discretion of the investigator precludes satisfactory participation in the study
- Hypopotassemia (K<3.5 mmol /l)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.
- Conditions
- Type 2 Diabetes
- Being tested
- Regular Human Insulin, Insulin Lispro, Insulin VIAject™ (75%), Insulin VIAject™ (90%)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Human InsulinDrug
0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal.
Insulin LisproDrug
90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal.
Insulin VIAject™ (75%)Drug
75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
Insulin VIAject™ (90%)Drug
90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
| Study group | Role | What they receive |
|---|---|---|
| Regular Human Insulin | Active comparator | Single Injection Receives: Drug: Regular Human Insulin |
| Inuslin Lispro (90%) | Active comparator | Single Injection Receives: Drug: Insulin Lispro |
| Insulin VIAject™ (75%) | Experimental | Single Injection Receives: Drug: Insulin VIAject™ (75%) |
| Insulin VIAject™ (90%) | Experimental | Single injection Receives: Drug: Insulin VIAject™ (90%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro.
Measured: 0 - 240 minutes
Secondary outcomes (1)
The secondary objectives are to evaluate the postprandial time course of arterial elasticity (pulse wave analysis; PWA), blood glucose, insulin, intact proinsulin, nitrotyrosine, glucagon, ICAM-1, VCAM, E-selectin.
Measured: 0 - 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Forst, MD, Principal investigator, IKFE Institute for Clinical Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849576
- Sponsor's protocol ID
- VIAject™-15J
- Status last verified
- Jul 2015
- First submitted
- 20 Feb 2009
- 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
- Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00849576
- Acronym / sponsor ID
- VIAject™-15J
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Feb 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.
The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regular Human Insulin | Active comparator | Drug: Regular Human InsulinSingle Injection |
| Inuslin Lispro (90%) | Active comparator | Drug: Insulin LisproSingle Injection |
| Insulin VIAject™ (75%) | Experimental | Drug: Insulin VIAject™ (75%)Single Injection |
| Insulin VIAject™ (90%) | Experimental | Drug: Insulin VIAject™ (90%)Single injection |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus according to the ADA criteria
- HbA1c between 6.5 % and 9.9 %
- Treatment with sulfonylurea and/or metformin in a stable dosage within the last 3 months
- Age between 40 and 75 years
- BMI < 40
Key exclusion criteria (19 listed)
- Type 1 diabetes mellitus
- Pre-treatment with insulin within the last 6 months prior to screening
- Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
- Untreated hypertension stage II-III according to WHO criteria
- Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
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 |
|---|---|---|
| Regular Human Insulin0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal. | Drug | Regular Human Insulin |
| Insulin Lispro90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal. | Drug | Inuslin Lispro (90%) |
| Insulin VIAject™ (75%)75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal | Drug | Insulin VIAject™ (75%) |
| Insulin VIAject™ (90%)90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal | Drug | Insulin VIAject™ (90%) |
Primary outcome
Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro.
Time frame: 0 - 240 minutes
1 secondary outcome
The secondary objectives are to evaluate the postprandial time course of arterial elasticity (pulse wave analysis; PWA), blood glucose, insulin, intact proinsulin, nitrotyrosine, glucagon, ICAM-1, VCAM, E-selectin.
Time frame: 0 - 240 minutes
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.
Thomas Forst, MD principal investigator
IKFE Institute for Clinical Research and Development
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 Regular Human Insulin, Insulin Lispro and Insulin VIAject™ (75%) in people with Type 2 Diabetes, run by Biodel at 1 site in Germany.
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 5 inclusion and 19 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 Germany. 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?
Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro. (time frame: 0 - 240 minutes). 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.