Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)
2 other identifiers
interventional
160
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2004
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 3, 2007
CompletedFirst Posted
Study publicly available on registry
April 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedJune 10, 2011
April 1, 2007
3.2 years
April 3, 2007
June 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
30 months
Interventions
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Alingsås Hospital
Alingsås, Sweden
Falu Hospital
Falun, Sweden
Capio Lundby Hospital
Gothenburg, 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
Malmo, 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
Vaxjo, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl-David Agardh, MD, phD
University Hospital MAS, Malmö, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 3, 2007
First Posted
April 4, 2007
Study Start
December 1, 2004
Primary Completion
March 1, 2008
Study Completion
April 1, 2008
Last Updated
June 10, 2011
Record last verified: 2007-04