E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the frequency of occurrence of hypoglycemia measured quarterly over one year. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequence of hypoglycemic events during the study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |