Diabetes Mellitus Type 1 MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Sponsors
BIODEL Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completed the VIAjectTM-06J protocol 2. Informed consent must be obtained in writing for all subjects 3. No deterioration of the initial status on VIAjectTM as judged by the investigator 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. History of frequent severe hypoglycemia within the prior six month which prevent study participation at the discretion of the Investigator 2. History of known hypersensitivity to any of the components in the study medication 3. Progressive disease likely to prove fatal 4. Known significant hepatic disease or serum AST values >3 upper limit of normal or bilirubin levels >1.5 upper limit of normal 5. Severe complications of diabetes mellitus including a history or findings 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 or recent onset of chronic foot ulcers or claudication, or the recent, clinically documented loss a pedal pulse 6. History of moderate to severe ketoacidosis within the last 3 month preceding screening for the study 7. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance 8. Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator 9. A sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy or a woman intending to become pregnant during the study 10. Abnormal ECG, safety lab or physical examination results which, in the opinion of the Investigator, render the participation of the subject in the study to be inappropriate or unsafe 11. 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 subject in the study to be inappropriate and unsafe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the frequency of occurrence of hypoglycemia measured quarterly over one year.;Secondary Objective: The secondary objectives of this study are to evaluate the change in the individual and group mean %HbA1C measured at every office visite after treatment start and over one year, changes in total daily prandial insulin dose, changes in total daily insulin dose, changes in body weight, changes in insulin antibody titers, the effects of insulin antibodies on glycemic control, the incidence of (serious) adverse events, the number of and reason for premature discontinuation, laboratory test abnormalities, ECG changes, vital sign changes of significance and injection site findings in subjects with type 1 diabetes mellitus after treatment for 12 month with VIAjectTM.;Primary end point(s): Frequence of hypoglycemic events during the study | — |
Countries
Germany
Outcome results
None listed