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Diabetes Mellitus, Type 1Phase 1/2NCT05351879

Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes

A Phase 1/2 study testing GAD-alum (Diamyd) 40 μg/mL in people with Diabetes Mellitus, Type 1, run by Linkoeping University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the study is to evaluate the feasibility and safety of administering a 4th or 5th intralymphatic booster dose of GAD-alum (Diamyd®) to T1D patients carrying HLA DR3-DQ2, who have earlier been treated with three or four intralymphatic doses of GAD-alum (Diamyd®) respectively. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
GAD-alum (Diamyd) 40 μg/mL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSweden
Study dates
9 May 2022to 29 Aug 2023
Phase
Phase 1/2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
  • T1D according to the ADA classification
  • Carry HLA DR3-DQ2 haplotype
  • Prior participation in either the DIAGNODE-1 or the DIAGNODE-2, having received four or three intralymphatic injections of Diamyd, respectively.
  • Females must agree to avoid pregnancy and have a negative urine pregnancy test.
  • Patients of childbearing potential must agree to use adequate contraception, until 90 days after the administration of Diamyd. Adequate contraception is as follows:
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  • For females of childbearing potential:
  • oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
  • combined (estrogen and progestogen containing)
  • oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
  • intrauterine device
  • intrauterine hormone-releasing system (for example, progestin-releasing coil)
  • bilateral tubal occlusion
  • vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
  • male partner using condom
  • abstinence from heterosexual intercourse
  • For males of childbearing potential:
  • condom (male)
  • abstinence from heterosexual intercourse

Who cannot join

  • Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
  • Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
  • Treatment with any oral or injected anti-diabetic medications other than insulin
  • Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the supplementation period
  • A history of anemia or significantly abnormal hematology results at screening
  • A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
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  • Clinically significant history of acute reaction to vaccines or other drugs in the past, including Diamyd
  • Treatment with any vaccine, including influenza or Covid19 vaccine, within 1 month prior to planned study drug dose administration or planned treatment with any vaccine up to 1 month after the injection with study drug
  • Participation in clinical trials (other than DIAGNODE-1 and DIAGNODE-2) with a new chemical entity within the previous 3 months
  • Inability or unwillingness to comply with the provisions of this protocol
  • A history of alcohol or drug abuse
  • A significant illness other than diabetes within 2 weeks prior to first dosing s
  • Ongoing diagnosed or suspected post-Covid19 syndrome
  • Known HIV or hepatitis
  • Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the Diamyd treatment)
  • Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
  • Deemed by the investigator not being able to follow instructions and/or follow the study protocol

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Kliniska Forskningsenheten (Hudmottagningen), Universitetssjukhuset Linköping

    Linköping, 581 85

Other trials in Sweden

About this study

Official title: A Phase I/II Open Label Pilot Study to Evaluate the Safety and Feasibility of an Additional Intralymphatic Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes

The objective of the study is to evaluate the feasibility and safety of administering a 4th or 5th intralymphatic booster dose of GAD-alum (Diamyd®) to T1D patients carrying HLA DR3-DQ2, who have earlier been treated with three or four intralymphatic doses of GAD-alum (Diamyd®) respectively.

Read the detailed description

The study is a phase I/II, single arm, open label pilot clinical trial. Eligible patients will receive one booster injection of Diamyd® administered into an inguinal lymph node.

The patients will be assessed for eligibility at the screening visit (Visit 1). Patients with a Vitamin D level <100 nmol/L (40 ng/mL) at screening will receive oral Vitamin D supplementation (2000 IU daily) for 60 days, starting 30 days prior to the injection. On Visit 2 (Day 0), patients eligible for the study will receive one intralymphatic injection of 4µg Diamyd®

Being tested
GAD-alum (Diamyd) 40 μg/mL
Keywords
Diamyd, Diabetes, Diabetes Type 1, Type 1 Diabetes, Type 1 Diabetes Mellitus, GAD65, GAD-Alum, rhGAD65 (Recombinant Human GAD with molecular mass 65,000), Vitamin D, Diabetes mellitus Type 1, Glutamic acid decarboxylase
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GAD-alum (Diamyd) 40 μg/mLBiological

    Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) adsorbed to Alhydrogel at a concentration of 40 μg/mL and is given as a sterile solution for intralymphatic injection

Study groups in NCT05351879
Study groupRoleWhat they receive
GAD-Alum (DIamyd) 40 μg/mL and Vitamin DExperimentalPatients with a Vitamin D level <100 nmol/L (40 ng/mL) at screening will receive oral Vitamin D supplementation (2000 IU daily) for 60 days, starting 30 days prior to the injection. On Visit 2 (Day 0), patients eligible for the study will receive one intralymphatic injection of 4µg Diamyd.
Receives: Biological: GAD-alum (Diamyd) 40 μg/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments

    Measured: 12 months

  2. Injection site reactions

    Measured: 3 months

  3. Occurrence of AEs and SAEs

    Measured: 12 months

  4. Number of Clinically Significant Abnormal Results From Laboratory measurements (hematology, clinical chemistry) and Urine analysis.

    Measured: 12 months

Secondary outcomes (6)

  1. Change in Stimulated C-peptide During a MMTT

    Measured: Baseline and 12 months

  2. Change in HbA1c

    Measured: Baseline and 12 months

  3. Change in daily exogenous insulin consumption

    Measured: Baseline and 12 months

  4. Change in insulin-dose-adjusted HbA1c (IDAA1c)

    Measured: Baseline and 12 months

  5. Change in time in glycemic target range 3.9 to 10 mmol/L

    Measured: Baseline and 12 months

  6. Change in time in hyperglycemic range > 10 mmol/L

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start9 May 2022
  3. Primary completion29 Aug 2023
  4. Study completion29 Aug 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05351879
Sponsor's protocol ID
DIAGNODE-B
Status last verified
Dec 2023
First submitted
14 Apr 2022
Last updated
11 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GAD-alum (Diamyd) 40 μg/mL in people with Diabetes Mellitus, Type 1, run by Linkoeping University at 1 site 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 19 inclusion and 17 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 11 Dec 2023. 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 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments (time frame: 12 months). 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?

On the ClinicalTrials.gov record for NCT05351879.

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 11 Dec 2023.

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