An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAJECT™ and Regular Human Insulin in Patients with Type 1 Diabetes Mellitus
- Conditions
- Diabetes Mellitus Type 1MedDRA version: 8.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
- Registration Number
- EUCTR2006-006599-39-DE
- Lead Sponsor
- BIODEL Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
1. Established diagnosis of type 1 diabetes for more than 1 year as defined
in section 3.4. of the study protocol
2. HbA1c values of not more than 10.5%
3. Three months on a stable insulin regimen that meets the current standard of care
and that includes at least two daily insulin injections
4. Age: 18 to 70 years
5. Body Mass Index: 18 - 38 kg/m2
6. Informed consent must be obtained in writing for all patients
7. Patients which are trained in intensified insulin therapy
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. Type 2 diabetes mellitus as determined by the investigator
2. History of frequent severe hypoglycemia within the prior six months
3. C-peptide > 1,0 ng/ml
4. History of known hypersensitivity to any of the components in the study
medication
5. History of severe or multiple allergies
6. Treatment with any diabetes-related investigational drug in the last 3 months before study entry or treatment with any non-diabetes related investigational drug within the last 30 days before study entry
7. Current treatment with systemic oral, injected, or inhaled corticosteroids
8. Progressive disease likely to prove fatal
9. History of malignancy within the past 5 years except for basal cell epithelioma
10. Known significant hepatic disease or serum AST or ALT values =3 X upper limit of
normal or bilirubin levels = 1.5 X upper limit of normal
11. Severe complications of diabetes mellitus including a history or finding of Stage
III or IV diabetic retinopathy, proteinuria > 2+ by urine dipstick, serum creatinine
of >1.8 mg/dl for males or >1.5 mg/dl for females, history of renal transplant,
severe peripheral vascular disease which has resulted in amputation, chronic
foot ulcers claudication or absent pedal pulses
12. Known history of autonomic neuropathy
13. History of moderate to severe ketoacidosis within the 3 months preceding
screening for the study
14. Current drug or alcohol abuse, or a history which in the opinion of the
Investigator will impair patient safety or protocol compliance.
15. Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal,
neurological, psychiatric and/or hematological disease as evaluated by the
Investigator
16. Blood donation within the last 30 days
17. A woman who is breast feeding
18. Pregnant women or women intending to become pregnant during the study
19. A sexually active woman of childbearing age not actively and consistently
practicing birth control by using a medically accepted device or therapy
20. Abnormal ECG, safety lab or physical examination results which, in the opinion of
the investigator, render the participation of the patient in the study to be
inappropriate or unsafe
21. A history of lack of compliance with medical instructions, recent drug or alcohol
abuse, or other reasons which, in the opinion of the investigator, render the
participation of the patient in the study to be inappropriate or unsafe
22. Patients with diabetes mellitus Type 1 utilizing insulin pumps
23. Current significant diseases of the adrenal gland, pituitary gland and thyroid gland at the discretion of the investigator
24. Glomerular Filtration Rate < 40ml/min
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method