Latent Autoimmune Diabetes in Adult (LADA) Clinical Trial
Official title:
A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)
| Verified date | April 2007 |
| Source | Diamyd Therapeutics AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | April 2008 |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 70 Years |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Alingsås Hospital | Alingsås | |
| Sweden | Falu Hospital | Falun | |
| Sweden | Capio Lundby Hospital | Göteborg | |
| Sweden | Härnösand Hospital | Härnösand | |
| Sweden | Helsingborg Hospital | Helsingborg | |
| Sweden | Karlstad Central Hospital | Karlstad | |
| Sweden | Central Hospital, Kristianstad | Kristianstad | |
| Sweden | Sunderby Hospital | Luleå | |
| Sweden | University Hospital MAS | Malmö | |
| Sweden | Vrinnevi Hospital | Norrköping | |
| Sweden | Odensala Health Clinic | Östersund | |
| Sweden | Skellefteå Hospital | Skellefteå | |
| Sweden | S:t Göran Hospital | Stockholm | |
| Sweden | Stockholm South General Hospital | Stockholm | |
| Sweden | Norrlands University Hospital | Umeå | |
| Sweden | Uppsala University Hospital | Uppsala | |
| Sweden | Växjö Central Hospital | Växjö |
| Lead Sponsor | Collaborator |
|---|---|
| Diamyd Therapeutics AB |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |