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

NCT05351879 | Completed Phase 1

• 1 other identifier: DIAGNODE-B
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

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

Outcome Measures

Primary Outcomes (4)

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

  12 months

• Injection site reactions

  3 months

• Occurrence of AEs and SAEs

  12 months

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

  12 months

Secondary Outcomes (6)

• Change in Stimulated C-peptide During a MMTT

  Baseline and 12 months

• Change in HbA1c

  Baseline and 12 months

• Change in daily exogenous insulin consumption

  Baseline and 12 months

• Change in insulin-dose-adjusted HbA1c (IDAA1c)

  Baseline and 12 months

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

  Baseline and 12 months

Study Arms (1)

GAD-Alum (DIamyd) 40 μg/mL and Vitamin D

EXPERIMENTAL

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.

Biological: GAD-alum (Diamyd) 40 μg/mL

Interventions

GAD-alum (Diamyd) 40 μg/mL BIOLOGICAL

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

GAD-Alum (DIamyd) 40 μg/mL and Vitamin D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Linkoeping University: lead
• Diamyd Medical AB: collaborator

Study Sites (1)

Kliniska Forskningsenheten (Hudmottagningen), Universitetssjukhuset Linköping

Linköping, 581 85, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Johnny Ludvigsson, Professor

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 28, 2022
• Study Start: May 9, 2022
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

SE (1)