Latent Autoimmune Diabetes in Adult (LADA)
Conditions
Keywords
Type 2 Diabetes, LADA, Latent Autoimmune Diabetes in Adult, Autoimmunity, HbA1c, C-peptide
Brief summary
This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).
Interventions
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
Sponsors
Diamyd Therapeutics AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years * Presence of GAD65 antibodies * Detectable C-peptide level * Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA) * Written informed Consent Key
Exclusion criteria
* Treatment with insulin * Intolerance to OHA * Secondary diabetes mellitus * History of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, HIV, hepatitis) * Treatment with any vaccine within one month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose * Participation in other clinical trials with a new chemical entity within the previous 3 months * Pregnancy (or planned pregnancy within one year after 2nd administration) * Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study * Significant illness other than diabetes within 2 weeks prior to first dosing * Unwillingness to comply with the provisions of the protocol * Clinically significant history of acute reaction to drugs in the past * Treatment with immunosuppressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement. | 30 months |
Countries
Sweden
Outcome results
None listed