Effect of Once vs Twice Daily Administration of Corticosteroids on Blood Glucose in Patients with Anca-Vasculitis Measured by Continuous Blood Glucose Monitoring - a Pilot Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

25 Sep 2020 → ongoing

Decision date (initial)

2024-11-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-516141-39-00

EudraCT number

2019-002068-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

Evaluation of whether splitting the cortisone dose to a twice daily dose leads to increased time in the glucose target range.

Secondary objectives 1

1. Evaluation of whether splitting the cortisone dose to a twice daily dose leads to an improvement in 24h blood sugar levels (hyperglycaemia, insulin

Conditions and MedDRA coding

anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Written agreement to participate in the study after detailed explanation of the study
2. Male or female patients
3. New diagnosis of ANCA-associated vasculitis or a relapse of a known ANCA vasculitis
4. Age: ≥18-80 years at the time of biopsy
5. Aprednislon dose of 1mg/kg body weight at the time of inclusion
6. Wants to wear a CGM system for the duration of the study and to receive insulin therapy as needed

Exclusion criteria 7

1. Known diabetes mellitus
2. Women capable of giving birth who are pregnant, breastfeeding, wish to become pregnant or do not use adequate contraception.
3. Skin changes or concomitant circumstances that prevent the placement of a glucose sensor in the examiner's assessment (e.g. scar tissue)
4. Current participation in another clinical trial that would affect study results
5. Relevant acute or chronic disease that, in the investigator's estimation, could affect the patient's safety or affect the study results.
6. Patient's inability to follow study procedures as required
7. Inability of the patient to understand the consent form

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean time in target range (70-180mg/dl) measured by blinded continuous glucose measurement (CGM).

Secondary endpoints 23

1. Number and percent of glucose values (CGM, BG) in the following ranges: 0-<40mg/dl (blood glucose only), 40-<70mg/dl, 70-<100mg/dl, 100-<140mg/dl, 140-<180mg/dl, 180-<300mg/dl, ≥300mg/dl
2. Time of glucose values (CGM, BG) in the following ranges: 0-<40mg/dl (blood glucose only), 40-<70mg/dl, 70-<100mg/dl, 100-<140mg/dl, 140-<180mg/dl, 180-<300mg/dl, ≥300mg/dl
3. Average daily blood glucose based on preprandial and bedtime glucose values: total and per treatment day
4. Mean blood glucose before the respective times: before breakfast, before lunch, before dinner, at bedtime
5. Mean blood glucose before start of study during in-patient stay
6. Number of insulin injections per day
7. Relevant concomitant medication during inpatient stay (corticosteroids, parenteral nutrition, oral antidiabetics)
8. Relevant diabetes medication for discharge from inpatient care (insulin therapy - type and dose, oral antidiabetics)
9. HbA1c
10. Sex
11. Age
12. Additionally affected organs
13. Antibody titer (ANCA, anti-GBM, anti-ds-DNS,..) at initial diagnosis and during course of disease
14. CRP at initial diagnosis and during course of treatment
15. Leukocytes at initial diagnosis and during course of disease
16. Thrombocytes at initial diagnosis and during course of disease
17. GFR at initial diagnosis and during course of disease
18. Creatinine at initial diagnosis and during course of disease
19. Protein and albuminuria at initial diagnosis and during course of disease
20. Urinary sediment at initial diagnosis and in the course of the disease
21. Therapy after initial diagnosis and during course (e.g. switch to rituximab)
22. Birmingham Vasculitis Score (BVAS) on discharge
23. Quality of life measured by the SF-36 and KDQOL questionnaire

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Coordination center for Clinical Trials

Public contact point

Organisation

Medical University Of Graz

Contact name

Coordination center for Clinical Trials

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications