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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01235039
• Date of registration: 02/11/2010
• Primary sponsor: Biodel
• Public title: 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
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 43
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01235039
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Tim Heise, M.D
• Affiliation: Profil Institut für Stoffwechselforschung GmbH

Key inclusion & exclusion criteria

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.



Age minimum: 19 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Drug: Insulin Lispro

Drug: VIAject®25

Drug: VIAject®7

Primary Outcome(s)

Serum insulin concentration [Time Frame: 0-480 minutes]

Secondary Outcome(s)

Glucose infusion rate [Time Frame: Between 0-240 minutes and 0-480 minutes]

Serum insulin concentration [Time Frame: 0-240 minutes]

Secondary ID(s)

VIAject -030J

Source(s) of Monetary Support

Please refer to primary and secondary sponsors