Latent Autoimmune Diabetes in Adult (LADA)Phase 2NCT00456027
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
A Phase 2 study testing rhGAD65 formulated in Alhydrogel® (Diamyd®) in people with Latent Autoimmune Diabetes in Adult (LADA), run by Diamyd Therapeutics AB at 17 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Latent Autoimmune Diabetes in Adult (LADA)
- What is being tested?
- rhGAD65 formulated in Alhydrogel® (Diamyd®)
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 17 sitesSweden
- Study dates
- Dec 2004to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Sweden17 sites
Alingsås Hospital
Alingsås
Falu Hospital
Falun
Capio Lundby Hospital
Gothenburg
Härnösand Hospital
Härnösand
Helsingborg Hospital
Helsingborg
Karlstad Central Hospital
Karlstad
Central Hospital, Kristianstad
Kristianstad
Sunderby Hospital
Luleå
University Hospital MAS
Malmö
Vrinnevi Hospital
Norrköping
Odensala Health Clinic
Östersund
Skellefteå Hospital
Skellefteå
S:t Göran Hospital
Stockholm
Stockholm South General Hospital
Stockholm
Norrlands University Hospital
Umeå
Uppsala University Hospital
Uppsala
Växjö Central Hospital
Vaxjo
About this study
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)
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).
- Being tested
- rhGAD65 formulated in Alhydrogel® (Diamyd®)
- Keywords
- Type 2 Diabetes, LADA, Latent Autoimmune Diabetes in Adult, Autoimmunity, HbA1c, C-peptide
- Medical subject headings
- Diabetes Mellitus, Type 2, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhGAD65 formulated in Alhydrogel® (Diamyd®)Drug
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startDec 2004
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Autoimmune Diabetes in Adult (LADA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamyd Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carl-David Agardh, MD, phD, Principal investigator, University Hospital MAS, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456027
- Sponsor's protocol ID
- D/P2/04/2
- Other IDs
- EUDRACT 2004-001998-25
- Status last verified
- Apr 2007
- First submitted
- 3 Apr 2007
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00456027
- Acronym / sponsor ID
- D/P2/04/2
- Keywords
- Type 2 Diabetes, LADA, Latent Autoimmune Diabetes in Adult, Autoimmunity, HbA1c, C-peptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Diamyd Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhGAD65 formulated in Alhydrogel® (Diamyd®)20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl-David Agardh, MD, phD principal investigator
University Hospital MAS, Malmö, Sweden
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhGAD65 formulated in Alhydrogel® (Diamyd®) in people with Latent Autoimmune Diabetes in Adult (LADA), run by Diamyd Therapeutics AB at 17 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.