Diabetes, Type IPhase 2DiViDNCT01129232
Diabetes Virus Detection Project, Intervention With GAD-alum
A Phase 2 study testing GAD-alum in people with Diabetes, Type I and Enterovirus Infections, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Diabetes, Type I, Enterovirus Infections, Autoimmunity
- What is being tested?
- GAD-alum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Jan 2013
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed classical type-1 diabetes
- Positive GAD antibodies
- Fasting C-peptide >0.1 mmol/l
- Insulin dosage >0.1 U/kg Bodyweight/day
Who cannot join
- Pregnancy
- Weaning
- Other chronic diseases than diabetes
- Any regular medication except oral contraceptives
- Psychiatric disturbances
Trial locations and contacts
1 site in 1 country.
Norway1 site
Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker
Oslo, 0514
About this study
Official title: A Phase II-study (Therapeutic Exploratory) of GAD-alum in Newly Diagnosed Type-1 Diabetic Patients, With Focus One the Presence of Viruses at the Time of Diagnosis
The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).
Read the detailed description
The aetiology of type 1 diabetes is unknown. Both genetic and environmental factors seem to be important for the destruction of insulin producing beta cells in the pancreas. Increasing indirect evidences exist that picornaviruses may either directly or indirectly through autoimmune processes destroy beta cells. New sensitive assays have been developed to detect these viruses and to study the immunological processes, especially T-cell function. Microsurgical technology has been refined, now making pancreatic biopsies a safe procedure. This study focuses on advanced in depth studies of immunology and virology in pancreatic tissue and small intestine at an early stage of disease.
- Conditions
- Diabetes, Type I, Enterovirus Infections, Autoimmunity
- Being tested
- GAD-alum, Placebo
- Keywords
- insulin
- Medical subject headings
- Diabetes Mellitus, Type 1, Enterovirus Infections, Autoimmune Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAD-alumDrug
Also called Diamyd
20 µg of GAD-alum injected sc after the biopsy, and repeated after one month
PlaceboOther
Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)
| Study group | Role | What they receive |
|---|---|---|
| GAD-alum | Experimental | GAD-alum administered at 0 and 1 months after inclusion Receives: Drug: GAD-alum |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
Measured: 18 months after inclusion
Prevalence of virus infected islets in pancreatic biopsies
Measured: 18 months after inclusion
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
Measured: 2 weeks after inclusion
Prevalence of virus infected islets in pancreatic biopsies
Measured: 2 weeks after inclusion
Secondary outcomes (3)
Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test
Will be measured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months
Measured: 36 months after diagnosis
Insulin dosage/kilo bodyweight/24 hours
Will be calculated at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is 36 months after diagnosis
Measured: 36 months after diagnosis
Glycosylated hemoglobin A1 (HbA1c)
Will be measrured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months. To investigate wether an eventual better endogenous insulin production gives better metabolic control, estimated by lower HbAic
Measured: 36 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Complications to procedure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type IStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Krogvold, Oslo University Hospital
- Investigators
- Knut Dahl-Jorgensen, Prof, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129232
- Sponsor's protocol ID
- 2009/1907 (REK)
- Other IDs
- 2008-002027-82, 2008
- Acronym
- DiViD
- Status last verified
- May 2018
- First submitted
- 11 May 2010
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II-study (Therapeutic Exploratory) of GAD-alum in Newly Diagnosed Type-1 Diabetic Patients, With Focus One the Presence of Viruses at the Time of Diagnosis
- ClinicalTrials.gov ID
- NCT01129232
- Acronym / sponsor ID
- DiViD / 2009/1907 (REK)
- Conditions
- Diabetes, Type I, Enterovirus Infections, Autoimmunity
- Keywords
- insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Complications to procedure
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 May 2010 (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.
The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).
Detailed description
The aetiology of type 1 diabetes is unknown. Both genetic and environmental factors seem to be important for the destruction of insulin producing beta cells in the pancreas. Increasing indirect evidences exist that picornaviruses may either directly or indirectly through autoimmune processes destroy beta cells. New sensitive assays have been developed to detect these viruses and to study the immunological processes, especially T-cell function. Microsurgical technology has been refined, now making pancreatic biopsies a safe procedure. This study focuses on advanced in depth studies of immunology and virology in pancreatic tissue and small intestine at an early stage of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAD-alum | Experimental | Drug: GAD-alumGAD-alum administered at 0 and 1 months after inclusion |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Newly diagnosed classical type-1 diabetes
- Positive GAD antibodies
- Fasting C-peptide >0.1 mmol/l
- Insulin dosage >0.1 U/kg Bodyweight/day
Key exclusion criteria (5 listed)
- Pregnancy
- Weaning
- Other chronic diseases than diabetes
- Any regular medication except oral contraceptives
- Psychiatric disturbances
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 |
|---|---|---|
| GAD-alumAlso: Diamyd20 µg of GAD-alum injected sc after the biopsy, and repeated after one month | Drug | GAD-alum |
| PlaceboPlacebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm) | Other | Placebo |
Primary outcome
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
Time frame: 18 months after inclusion
Prevalence of virus infected islets in pancreatic biopsies
Time frame: 18 months after inclusion
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
Time frame: 2 weeks after inclusion
Prevalence of virus infected islets in pancreatic biopsies
Time frame: 2 weeks after inclusion
3 secondary outcomes
Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test
Time frame: 36 months after diagnosis
Insulin dosage/kilo bodyweight/24 hours
Time frame: 36 months after diagnosis
Glycosylated hemoglobin A1 (HbA1c)
Time frame: 36 months after diagnosis
Results and safety
The study was stopped early (reason given: Complications to procedure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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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.
Knut Dahl-Jorgensen, Prof principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GAD-alum in people with Diabetes, Type I and Enterovirus Infections, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Complications to procedure). Results are not available in the source record.
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?
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies (time frame: 18 months after inclusion). The study lists 4 primary outcomes in all. 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 17 May 2018.