Type 1 or Type 2 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: VIAject ® 25
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061680
Concentration unit: IU/ml international unit(s)/mi
Sponsors
BIODEL inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years 2. Body Mass Index 18-37 kg/m2 3. Males or females diagnosed with type 1 or 2 diabetes mellitus for at least 1 year 4. Subject must usually self-inject both basal and meal-time insulin injections to control diabetes (at least 2 injections/day) and must have done so for at least 3 months prior to the study. 5. The usual short- or fast- (rapid) acting insulin dose for the meal to be studied must be between 5 and 25 units inclusive. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. HbA1c value of > 10.0% 2. History of hypersensitivity to any of the components in the study medication 3. History of insulin allergy 4. Treatment with any other investigational drug in the last 3 months before study entry 5. Treatment with oral or parenteral corticosteroids at the time of screening or anticipated use during the course of the study. 6. Regular use of analgesics (Daily doses of up to 100 mg aspirin are acceptable) 7. Any chronic pain syndrome, e.g., chronic neuropathic pain, fibromyalgia, etc. 8. Progressive disease likely to prove fatal (e.g., malignancies) 9. Current drug or alcohol use, positive recreational drug screen or a history of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance or assessment of injection site discomfort. 10. Significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator 11. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the investigator. In particular, subjects with elevated liver enzymes (AST or ALT > 3 times the upper limit of normal) or impaired renal function (elevated serum creatinine values > 1.5 times the upper limit of normal) will not be allowed to enter the trial. 12. A woman who is lactating 13. Pregnant women or women intending to become pregnant during the study 14. 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). 15. Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator 16. Lack of understanding of pain scales or other aspects of the study. 17. Lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study 18. Subjects who have been dosed with study drug in any previous VIAject® clinical trial. 19. Positive serology for HIV, hepatitis B, or hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To test the hypothesis that VIAject® 7 is associated with significantly less injection site discomfort than VIAject® 25. • To estimate the level of injection site discomfort with VIAject® 7 relative to that with insulin lispro. ;Secondary Objective: • To evaluate erythema or edema formation with VIAject® 7 compared to that with VIAject® 25 and insulin lispro. • To evaluate safety of VIAject® 7, VIAject® 25 , and insulin lispro ;Primary end point(s): Injection site discomfort as assessed using a 100 mm Visual Analog Scale (VAS). | — |
Countries
Germany
Outcome results
None listed