The RADIAL study: A clinical trial to learn more about the benefits and the acceptability of trials that include technology to centre the trial around the participant, known as decentralised, and hybrid clinical trials compared to standard clinical trials that take place in hospitals or in research centres, in patients with type 2 diabetes mellitus treated with Toujeo®, a drug to help manage blood sugar levels.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Medical Center Utrecht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

3 Aug 2023 → 20 Nov 2024

Decision date (initial)

2022-11-02

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

European Federation of Pharmaceutical Industries Associations · Innovative Medicines Initiative

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

1. To assess potential benefits of a DCT approach on participant recruitment, retention, diversity, site and participant satisfaction, and cost.
2. To determine acceptability of a DCT approach by measuring variables related to safety oversight, treatment adherence and data quality (missing data and query rate) within the arms that have a different degree of decentralisation.

Secondary objectives 1

1. To determine whether the efficacy of treatment with Toujeo® (insulin glargine 300 U/mL) is within the accepted range within the arms with different degree of decentralisation.

Conditions and MedDRA coding

Type 2 diabetes mellitus (T2DM)

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1) Participant with T2DM diagnosed for at least 1 year before the screening visit (V1).
2. 2) Participant treated as part of their treatment with a basal insulin (i.e. type of insulin and time/frequency of the injection), for at least 3 months before the screening visit.
3. 3) The total daily basal insulin dose should be stable (±20%) for at least 1 month before the screening visit.
4. 4) Signed written informed consent or e-consent depending on the arm.
5. 5) Participant's mental and physical status allows them to be able to perform their activities of daily living with no or minimal assistance, including the ability to administer injectable insulin and measure their blood glycaemic level.
6. 6) Willing and able to permit home visits (only for Part A of the study).
7. 7) Willing and able to comply with study drug receipt, accountability, and return processes and procedures.
8. 8) Access to tablet/smartphone with Bluetooth functionality.
9. 9) Access to internet connection that allows remote data entry and, for part B, video conferencing.

Exclusion criteria 1

1. 1) Age <18 years. 2) HbA1c at screening visit: <7.0% or >10.0%. 3) Patient not willing to self-manage insulin titration algorithm. 4) Type 1 diabetes mellitus. 5) Treatment with mixed insulin (premixes) during the 3 months before the screening visit. 6) Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening. 7) Any clinically significant abnormality identified at the time of screening, or any condition (including known substance or alcohol abuse, or psychiatric disorder) that in the opinion of the Investigator or any sub-Investigator would make implementation of the protocol or interpretation of the study results difficult or would preclude the safe participation of the participant in this study. 8) Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening visit. 9) Participant is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. 10) Participant whom the investigator deems otherwise ineligible (e.g. unable to understand and follow instructions). Reason for ineligibility will be documented. 11) Pregnant or breastfeeding woman at the time of screening. 12) Woman of childbearing potential not protected by acceptable method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy (see Section 10.3). 13) Known hypersensitivity / intolerance to insulin glargine or any of Toujeo® excipients. 14) Participant who withdraws consent during the screening (participant who is not willing to continue or fails to return). 15) Despite screening of the participant, enrolment is stopped at the study level.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective 1: Time to enrolment from Site activation until last participant enrolled; Proportion of participants completing the study period; Various diversity aspects such as race, ethnicity, socioeconomic status etc. Objective 2: Time from event occurrence to collection AE/SAE in the eDiary or eCRF. Adherence to the daily insulin injection by means of eDiary analysis in percentage of days of documented intake until participant's EOT

Secondary endpoints 1

1. HbA1c change from baseline to Week 24; HbA1c change from baseline to Week 12; Fasting SMPG change from baseline to Week 24; Fasting SMPG change from baseline to Week 12; Percentage (%) of participants reaching HbA1c level <7% (53 mmol/mol) at Week 12 and Week 24; Percentage (%) of participants reaching fasting SMPG target of 80–130 mg/dL (4.4 -7.2 mmol/L) at Week 12 and 24; Percentage (%) of participants reaching target HbA1c <7% (53 mmol/mol) Week 12 and Week 24 without severe and/or confirmed

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Medical Center Utrecht

Sponsor organisation

University Medical Center Utrecht

Address

Heidelberglaan 100

City

Utrecht

Postcode

3584 CX

Country

Netherlands

Scientific contact point

Organisation

University Medical Center Utrecht

Contact name

Project Manager

Public contact point

Organisation

University Medical Center Utrecht

Contact name

Project Manager

Third parties 1

Locations

5 EU/EEA countries · 37 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 41 files

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

Application history

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