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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Germany1 site

IKFE
Parcusstrasse 8, Mainz, 55116

Other trials in Germany

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 groups in NCT00849576
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.

Apr 2008Aug 2008

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

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.

Related trials for Type 2 Diabetes

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Active, not recruiting
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Recruiting
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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?

On the ClinicalTrials.gov record for NCT00849576.

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.