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CompletedNCT00456027Updated Jun 10, 2011

Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)

A Phase 2 interventional study of rhGAD65 formulated in Alhydrogel® (Diamyd®) in Latent Autoimmune Diabetes in Adult (LADA), sponsored by Diamyd Therapeutics AB. Completed at 17 sites in Sweden. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-06-10.

Sponsored by Diamyd Therapeutics AB · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
30 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Latent Autoimmune Diabetes in Adult (LADA)

Keywords

  • Type 2 Diabetes
  • LADA
  • Latent Autoimmune Diabetes in Adult
  • Autoimmunity
  • HbA1c
  • C-peptide
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 160 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Diamyd Therapeutics AB is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (actual)

Interventions

  • DrugrhGAD65 formulated in Alhydrogel® (Diamyd®)

    20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart

06

What researchers measure

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.

    Time frame: 30 months

07

Study locations

17 sites
  • Alingsås Hospital
    Alingsås, Sweden
  • Falu Hospital
    Falun, Sweden
  • Capio Lundby Hospital
    Göteborg, Sweden
  • Helsingborg Hospital
    Helsingborg, Sweden
  • Härnösand Hospital
    Härnösand, Sweden
  • Karlstad Central Hospital
    Karlstad, Sweden
  • Central Hospital, Kristianstad
    Kristianstad, Sweden
  • Sunderby Hospital
    Luleå, Sweden
  • University Hospital MAS
    Malmö, Sweden
  • Vrinnevi Hospital
    Norrköping, 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, Sweden
  • Odensala Health Clinic
    Östersund, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00456027
Lead sponsor
Diamyd Therapeutics AB
First posted
Apr 4, 2007
Start date
Dec 2004
Primary completion
Mar 2008
Completion
Apr 2008
Last update
Jun 10, 2011

Study contacts

Carl-David Agardh, MD, phD
principal investigator · University Hospital MAS, Malmö, Sweden

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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