Diabetes Mellitus Type 2 MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Biodel Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects with type 2 diabetes must present with the following: 1. Completed the VIAject™-08J protocol 2. Informed consent must be obtained in writing for all subjects. 2. 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: Subjects presenting with any of the following will not be included in the study: 1. History of frequent severe hypoglycemia within the prior six months 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 or ALT values > 3 times the upper limit of normal or bilirubin levels > 1.5 times the upper limit of normal 5. Severe complications of diabetes mellitus including a history or finding of Stage III or IV diabetic retinopathy (see Appendix B), 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 3 months 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 or unsafe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The frequency of occurrence of hypoglycemia measured quarterly over one year.;Secondary Objective: 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, and the change in the individual and group mean %HbA1C measured quarterly and over one year.;Primary end point(s): Frequency of hypoglycemic events during study participation | — |
Countries
Germany
Outcome results
None listed