Diabetes MellitusPhase 1/2NCT01235039
A Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
A Phase 1/2 study testing VIAject®25, VIAject®7 and Insulin Lispro in people with Diabetes Mellitus, run by Biodel at 1 site in Germany.
Trial summary
The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25 and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7 with those of VIAject®25 and insulin lispro. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- VIAject®25, VIAject®7 and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Sep 2009
- Phase
- Phase 1/2
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥19 to ≤65 years
- Body Mass Index: ≥18 - ≤28 kg/m2
- Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
- Insulin antibody less than or equal to 10 µU/mL at screening
- Non-smoker, defined as no nicotine consumption for at least one year.
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Who cannot join
- Type 2 Diabetes Mellitus
- C-peptide value of >1.0 ng/mL
- HbA1c value of > 10.0%
- History of hypersensitivity to any of the components in the study medication
- History of severe or multiple allergies
- Treatment with any other investigational drug in the last 3 months before study entry
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- Any systemic treatment with drugs known to interfere with glucose metabolism such as systemic corticoids, non-selective beta-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization.
- Changes (type of drug or dose) in concomitant medication other than insulin or insulin analogues in the last 3 weeks prior to randomization.
- Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol/acetaminophen is permitted.
- Progressive disease likely to prove fatal (e.g. malignancies)
- Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety or protocol compliance
- Significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
- Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (serum creatinine values above the upper limit of normal) will not be allowed to enter the trial.
- Any serious systemic infectious disease during the four weeks prior to the first dose of study drug, as judged by the Investigator.
- History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose a risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- Blood donation within the last 30 days
- A woman who is lactating
- Pregnant women or women intending to become pregnant during the study
- A sexually active woman - not using adequate contraceptive methods (adequate contraceptive measures include: implants, injectables, combined oral contraceptives, hormonal intrauterine device [IUD], sexual abstinence or vasectomized partner)
- Positive serology for HIV, Hepatitis B or Hepatitis C
- Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the Investigator
- Lack of compliance or other reasons which, in the opinion of the Investigator, prevent the participation of the subject in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Double Blind, Randomized Crossover Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25 and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7 with those of VIAject®25 and insulin lispro.
- Conditions
- Diabetes Mellitus
- Being tested
- VIAject®25, VIAject®7, Insulin Lispro
- 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®25Drug
Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL
VIAject®7Drug
One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL
Insulin LisproDrug
One vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | VIAject®25 for subcutaneous application Receives: Drug: VIAject®25 |
| Formulation B | Experimental | VIAject®7 for subcutaneous application Receives: Drug: VIAject®7 |
| Formulation C | Experimental | Insulin Lispro for subcutaneous application Receives: Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum insulin concentration
Area under the serum insulin concentration curve for the time interval 0-480 min (AUC-INS 0-480) and maximum serum insulin concentration (C-INS max) (VIAject®7and VIAject®25 only)
Measured: 0-480 minutes
Secondary outcomes (2)
Serum insulin concentration
- AUC-INS: area under the serum insulin concentration curve for the time period 0-240 minutes
- AUC-INS: area under the serum insulin concentration curve for the time period 0 (VIAject® dosing) to the time when the insulin value returns to baseline
Measured: 0-240 minutes
Glucose infusion rate
•AUCGIR: area under the glucose infusion rate curve for the following time periods: 0-240, 0-480 minutes
Measured: Between 0-240 minutes and 0-480 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionSep 2009
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Heise, M.D, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235039
- Sponsor's protocol ID
- VIAject -030J
- Status last verified
- Jul 2015
- First submitted
- 2 Nov 2010
- 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
- A Single Center, Double Blind, Randomized Crossover Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01235039
- Acronym / sponsor ID
- VIAject -030J
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 5 Nov 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 primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25 and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7 with those of VIAject®25 and insulin lispro.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: VIAject®25VIAject®25 for subcutaneous application |
| Formulation B | Experimental | Drug: VIAject®7VIAject®7 for subcutaneous application |
| Formulation C | Experimental | Drug: Insulin LisproInsulin Lispro for subcutaneous application |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: ≥19 to ≤65 years
- Body Mass Index: ≥18 - ≤28 kg/m2
- Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
- Insulin antibody less than or equal to 10 µU/mL at screening
- Non-smoker, defined as no nicotine consumption for at least one year.
Key exclusion criteria (22 listed)
- Type 2 Diabetes Mellitus
- C-peptide value of >1.0 ng/mL
- HbA1c value of > 10.0%
- History of 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®25Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL | Drug | Formulation A |
| VIAject®7One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL | Drug | Formulation B |
| Insulin LisproOne vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL | Drug | Formulation C |
Primary outcome
Serum insulin concentration
Time frame: 0-480 minutes
Area under the serum insulin concentration curve for the time interval 0-480 min (AUC-INS 0-480) and maximum serum insulin concentration (C-INS max) (VIAject®7and VIAject®25 only)
2 secondary outcomes
Serum insulin concentration
Time frame: 0-240 minutes
Glucose infusion rate
Time frame: Between 0-240 minutes and 0-480 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 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.
Tim Heise, M.D principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VIAject®25, VIAject®7 and Insulin Lispro in people with Diabetes Mellitus, 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 6 inclusion and 22 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.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serum insulin concentration (time frame: 0-480 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 29 Jul 2015.