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.
Conditions
Interventions
Product Name: Diamyd
Product Code: rh GAD65
Pharmaceutical Form: Solution for injection
Current Sponsor code: rhGAD65
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concen
Sponsors
Diamyd Therapeutics AB
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: None;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. | — |
Countries
Sweden
Outcome results
None listed