A Single-Center, Double Blind, Randomized Crossover Study Evaluating Injection Site Toleration of VIAject® 7, VIAject® 25 and Insulin Lispro in Subjects with Type 1 or Type 2 Diabetes Mellitus
- Conditions
- Type 1 or Type 2 Diabetes MellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2009-013264-39-DE
- Lead Sponsor
- BIODEL inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To test the hypothesis that VIAject® 7 is associated with significantly less injection <br> site discomfort than VIAject® 25.<br>• To estimate the level of injection site discomfort with VIAject® 7 relative to that <br> with insulin lispro.<br>;Secondary Objective: • To evaluate erythema or edema formation with VIAject® 7 compared to that with <br> VIAject® 25 and insulin lispro.<br>• To evaluate safety of VIAject® 7, VIAject® 25 , and insulin lispro<br>;Primary end point(s): Injection site discomfort as assessed using a 100 mm Visual Analog Scale (VAS).<br><br>
- Secondary Outcome Measures
Name Time Method