NCT02464033

Open Label Trial to Evaluate the Tolerability of a Combination Therapy Consisting of GAD-alum (Diamyd®), Etanercept and Vitamin D in Children and Adolescents Newly Diagnosed With Type 1 Diabetes

Completed Phase 2 Results posted Last updated 26 March 2021

What this trial tests

Phase 2 trial testing GAD-Alum in Diabetes Mellitus, Type 1 in 20 participants. Completed in 25 February 2019.

Timeline

1 May 2015

Primary endpoint
25 February 2019

25 February 2019

Quick facts

Lead sponsor	Johnny Ludvigsson
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 May 2015
Primary completion	25 February 2019
Estimated completion	25 February 2019
Sites	8 locations across Sweden

Drugs / interventions tested

• GAD-Alum — full drug profile →
• Vitamin D
• Etanercept (etanercept) — full drug profile →

Conditions studied

• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Johnny Ludvigsson — full company profile →

Who can join

Adults 8 to 18, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability
  Time frame: 1 months
  Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse
• Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability
  Time frame: 2 months
  Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse
• Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline
  Time frame: Month 1, 2, 3, 6, 9, 15 and 30
  Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability.
• Number of Patients With Clinically Significant Laboratory Findings
  Time frame: Month 1, 2, 3, 6, 9, 15 and 30
  Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability
• GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)
  Time frame: 6 months
  GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000
• GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)
  Time frame: 15 months
  GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000

Sponsor's own description

The objectives of this study is to:

* Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept
* Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cytokines in type 1 diabetes: mechanisms of action and immunotherapeutic targets.
   Lu J, Liu J, Li L, Lan Y, et al · · 2020 · cited 116× · PMID 32185024 · DOI 10.1002/cti2.1122
2. Combination Immunotherapy for Type 1 Diabetes.
   Bone RN, Evans-Molina C. · · 2017 · cited 30× · PMID 28534310 · DOI 10.1007/s11892-017-0878-z
3. Evolving Antibody Therapies for the Treatment of Type 1 Diabetes.
   Ke Q, Kroger CJ, Clark M, Tisch RM. · · 2020 · cited 23× · PMID 33679717 · DOI 10.3389/fimmu.2020.624568
4. Impaired vibrotactile sense in children and adolescents with type 1 diabetes - Signs of peripheral neuropathy.
   Ising E, Dahlin LB, Elding Larsson H. · · 2018 · cited 20× · PMID 29672623 · DOI 10.1371/journal.pone.0196243
5. Delivery route considerations for designing antigen-specific biomaterial strategies to combat autoimmunity.
   Ackun-Farmmer MA, Jewell CM. · · 2023 · cited 15× · PMID 36938103 · DOI 10.1002/anbr.202200135
6. Epitope-based precision immunotherapy of Type 1 diabetes.
   Firdessa Fite R, Bechi Genzano C, Mallone R, Creusot RJ. · · 2023 · cited 10× · PMID 36656048 · DOI 10.1080/21645515.2022.2154098
7. Have we pushed the needle for treatment of Type 1 diabetes?
   Naushad N, Perdigoto AL, Rui J, Herold KC. · · 2017 · cited 7× · PMID 28992525 · DOI 10.1016/j.coi.2017.09.004
8. Antigen-specific immunotherapy combined with a regenerative drug in the treatment of experimental type 1 diabetes.
   Villalba A, Rodriguez-Fernandez S, Perna-Barrull D, Ampudia RM, et al · · 2020 · cited 6× · PMID 33144616 · DOI 10.1038/s41598-020-76041-1