E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients for the proposed study are those with Latent Autoimmune Diabetes in Adults (LADA). The presence of GAD 65 antibodies in this group identifies a single category of diabetes patients with ongoing auto-immunity to GAD65.
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MedDRA Classification |
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 objective is to follow the long-term safety and the development of diabetes status in the study population. The development over time for safety variables like injection site discomfort, vital signs, laboratory values and AEs/SAEs will be described for the study population. The development of diabetes status , i.e. HbA1c, C-peptide, blood glucose and insulin treatment will also be described. Total study duration for the patient is 2,5 years.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male and female patients of any race aged between 30-70 years. 2.Diagnosed with type II diabetes mellitus within previous 5 years. 3.Presence of GAD65 antibodies. 4.Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHAs). 5.Detectable c-peptide level, i.e. value above detection limit of the method used by the certified laboratory. 6. Patients who have given written informed consent.
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E.4 | Principal exclusion criteria |
1.Patients on insulin treatment or who have received insulin in the past 2.Patients with intolerance to OHA 3.Patients with secondary diabetes mellitus. 4.Patient on immunosuppression treatment 5.Patients with a history of anaemia or significantly abnormal haematology results at sceening 6.Patients with a history of epilepsy, head trauma or cerebrovascular accident or clinical features of SMS (continuous motor unit activity in proximal muscles). 7.Patients with a clinically significant history of acute reaction to drugs in the past. 8.Patients who have received any other vaccines within one month prior to planned “prime” dose or are planned to receive other vaccines up to 2 months after the last injection with Diamyd. 9.Patients who have participated in other clinical trials with an NCE within the previous 3 months. 10.Patients unable or unwilling to comply with the provisions of this protocol. 11.Patients with history of alcohol or drug abuse. 12.Patients with a significant illness other than diabetes within 2 weeks prior to first dosing. 13.Patients with HIV or hepatitis. 14.Females child-bearing at the time of injection or who plan for pregnancy during the next 13 months (one year after 2nd administration). 15.Presence of associated serious disease or condition which in the opinion of the investigator will exclude the patient from the trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
There will be no efficacy endpoints. However the development of diabetes will be followed over time by HbA1c, C-peptide, blood glucose and insulin treatment.
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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 | No |
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 | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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.8.5 | 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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |