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

• Conditions: Type 1 Diabetes Mellitus; MedDRA version: 9.1Level: LLTClassification code 10045238Term: Type I diabetes mellitus without mention of complication

• Registration Number: EUCTR2009-012082-54-DE
• Lead Sponsor: BIODEL inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age: =19 to =65 years
2. Body Mass Index: =18 - =28 kg/m2
3. Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
4. Insulin antibody less than or equal to 10 µU/mL at screening
5. Non-smoker, defined as no nicotine consumption for at least one year.
6. 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Type 2 Diabetes Mellitus
2. C-peptide value of >1.0 ng/mL
3. HbA1c value of > 10.0%
4. History of hypersensitivity to any of the components in the study medication
5. History of severe or multiple allergies
6. Treatment with any other investigational drug in the last 3 months before study entry
7. 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.
8. Changes (type of drug or dose) in concomitant medication other than insulin in the last 3 weeks prior to randomization.
9. 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.
10. Progressive disease likely to prove fatal (e.g. malignancies)
11. 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
12. Significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
13. 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.
14. Any serious systemic infectious disease during the four weeks prior to the first dose of study drug, as judged by the Investigator.
15. 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.
16. Blood donation within the last 30 days
17. A woman who is lactating
18. Pregnant women or women intending to become pregnant during the study
19. A sexually active woman - not using adequate contraceptive methods (adequate contraceptive measures include: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomized partner)
20. Positive serology for HIV, Hepatitis B or Hepatitis C
21. Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the Investigator
22. Lack of compliance or other reasons which, in the opinion of the Investigator, prevent the participation of the subject in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to test for the bioequivalence of VIAject®7 and VIAject™25 .;Secondary Objective: The secondary objective of the trial is:<br>- to compare the pharmacokinetic characteristics of VIAject®7 with those of VIAject™25 <br>- To compare the pharmacodynamic characteristics of VIAject®7 with those of VIAject™ 25<br>- To evaluate safety and tolerability of VIAject™ 7, insulin lispro, and VIAject™25 <br>- To compare the pharmacokinetic characteristics of VIAject®7with those of insulin lispro<br>- To compare the pharmacodynamic characteristics of VIAject®7with those of insulin lispro<br>;Primary end point(s): Test for bioequivalence between VIAject ™ 25 and VIAject ® 7.