- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235039
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
July 28, 2015 updated by: Biodel
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Neuss, Germany, 41460
- Profil Institut für Stoffwechselforschung GmbH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Formulation A
VIAject®25 for subcutaneous application
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Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL
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Experimental: Formulation B
VIAject®7 for subcutaneous application
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One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL
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Experimental: Formulation C
Insulin Lispro for subcutaneous application
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One vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
0-480 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum insulin concentration
Time Frame: 0-240 minutes
|
|
0-240 minutes
|
Glucose infusion rate
Time Frame: Between 0-240 minutes and 0-480 minutes
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•AUCGIR: area under the glucose infusion rate curve for the following time periods: 0-240, 0-480 minutes
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Between 0-240 minutes and 0-480 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tim Heise, M.D, Profil Institut für Stoffwechselforschung GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
November 2, 2010
First Submitted That Met QC Criteria
November 3, 2010
First Posted (Estimate)
November 5, 2010
Study Record Updates
Last Update Posted (Estimate)
July 29, 2015
Last Update Submitted That Met QC Criteria
July 28, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIAject -030J
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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