Immune response to COVID-19 Vaccination in people with Diabetes Mellitus

Phase 1

• Conditions: Type 1 Diabetes MellitusType 2 Diabetes Mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-001459-15-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-22
• Study Completion: 2022-06-24
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

Inclusion criteria for Diabetes Mellitus Cohort
-Age between 18 and 80 years, both inclusive
-Planned COVID-19 vaccination

Cohort I (Diabetes mellitus Type 1, well controlled)
Glycated haemoglobin levels HbA1c =7.5 %

Cohort II (Diabetes mellitus Type 1, uncontrolled)
Glycated haemoglobin levels HbA1c >7.5 %

Cohort III (Diabetes mellitus Type 2, well controlled)
Glycated haemoglobin levels HbA1c =7.5 %

Cohort IV (Diabetes mellitus Type 2, uncontrolled)
Glycated haemoglobin levels HbA1c >7.5 %

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Exlcusion criteria for Diabetes Mellitus Cohort
-Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
-Pregnancy or intention of becoming pregnant; breastfeeding
-Immunosuppressive therapy
-Acute or chronic inflammatory disorder
-Alcohol abuse (more than 15 drinks / week)
-Any contraindication to the vaccine planned to receive as listed in the product characteristics
-Previous COVID-19 vaccine or episode of COVID-19

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified