Type 1 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045238 Term: Type I diabetes mellitus without mention of complication
Conditions
Interventions
Product Name: VIAjectTM
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061680
Concentration unit: IU/ml international unit(s)/millilitre
Conce
Sponsors
Biodel Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 uU/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
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 (elevated 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 test 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 vasectomised 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test for bioequivalence between VIAject™ 25 and three other formulations of VIAject™ (VIAject™ 100, VIAject A™ 25 and VIAject A™ 100);Secondary Objective: The secondary objectives of this study are to compare the pharmacokinetic characteristics of VIAjectTM 25 with those of three other formulations of VIAjectTM (VIAject™ 100, VIAject A™ 25 and VIAject A™ 100) and to compare the pharmacodynamic characteristics of VIAjectTM 25 with those of three other formulations of VIAjectTM (VIAject™ 100, VIAject A™ 25 and VIAject A™ 100). Furthermore the safety and tolerability of VIAject™ 25, VIAject™ 100, VIAject A™ 25 and VIAject A™ 100 will be evaluated. To evaluate the safety profile of the formulations VIAject™ 100 compared to VIAject™ 25, VIAject A™ 25 compared to VIAject™ 25 and VIAject A™ 100 compared to VIAject™ 25 as assessed by ECG, standard safety laboratory parameters and incidence of adverse events after subcutaneous injection ;Primary end point(s): Test for bioequivalence between VIAject™ 25 and three other formulations of VIAject™ (VIAject™ 100, VIAject A™ 25 and VIAject A™ 100). | — |
Countries
Germany
Outcome results
None listed