Diabetes Mellitus Type 1 MedDRA version: 8.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Sponsors
BIODEL Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The mean changes in HbA1c from baseline to end of study in patients with type 1 diabetes mellitus after treatment for six months with VIAJECT™ as prandial insulin in comparison to the mean changes in HbA1c from baseline to end of study when treated with regular human insulin as prandial insulin.;Secondary Objective: Differences between study arms in 7-point glucose profile, changes in fasting glucose, changes in total daily insulin dose, changes in body weight, changes in insulin antibody titers, the effects of insulin antibodies on glycemic control, the proportion of patients in each group reaching HbA1c target and the mean HbA1c level achieved in each study arm.;Primary end point(s): | — |
Countries
Germany
Outcome results
None listed