Clinical trial NCT00456027: Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Latent Autoimmune Diabetes in Adult (LADA)
Keywords: Type 2 Diabetes
LADA
Latent Autoimmune Diabetes in Adult
Autoimmunity
HbA1c
C-peptide
Lead sponsor: Diamyd Therapeutics AB
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alingsås
country: Sweden
facility: Alingsås Hospital
city: Falun
country: Sweden
facility: Falu Hospital
city: Göteborg
country: Sweden
facility: Capio Lundby Hospital
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Härnösand
country: Sweden
facility: Härnösand Hospital
city: Karlstad
country: Sweden
facility: Karlstad Central Hospital
city: Kristianstad
country: Sweden
facility: Central Hospital, Kristianstad
city: Luleå
country: Sweden
facility: Sunderby Hospital
city: Malmö
country: Sweden
facility: University Hospital MAS
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
city: Skellefteå
country: Sweden
facility: Skellefteå Hospital
city: Stockholm
country: Sweden
facility: S:t Göran Hospital
city: Stockholm
country: Sweden
facility: Stockholm South General Hospital
city: Umeå
country: Sweden
facility: Norrlands University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Växjö
country: Sweden
facility: Växjö Central Hospital
city: Östersund
country: Sweden
facility: Odensala Health Clinic
Study officials:
affiliation: University Hospital MAS, Malmö, Sweden
name: Carl-David Agardh, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: