Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult) (NCT00456027) | Clinical Trial Compass
CompletedPhase 2
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
Sweden160 participantsStarted 2004-12
Plain-language 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).
Who can participate
Age range30 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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.