Diabetes Mellitus, Type 2 Clinical Trial
— RADIALOfficial title:
Pan-European Proof-of-concept Study Comparing Decentralised Clinical Trial (DCT) and Hybrid Approaches to Conventional Clinical Trial Approaches in Patients With Type 2 Diabetes Mellitus Treated With Toujeo®
Verified date | June 2024 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pan-European proof-of-concept study comparing Decentralised Clinical Trial (DCT) and hybrid approaches to conventional clinical trial approaches in patients with Type 2 diabetes mellitus treated with Toujeo®.
Status | Active, not recruiting |
Enrollment | 107 |
Est. completion date | November 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant with T2DM diagnosed for at least 1 year before the screening visit (V1). 2. Participant treated with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. 3. The total daily basal insulin dose should be stable (±20%) for at least 1 month before the screening visit. 4. Participant treated with =1 noninsulin antidiabetic drugs at stable dose in the 3 months before the screening visit. 5. Signed written informed consent or e-consent depending on the arm. 6. 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. 7. Willing and able to permit home visits (only for Part A of the study). 8. Willing and able to comply with study drug receipt, accountability, and return processes and procedures. 9. Access to tablet/smartphone with Bluetooth functionality. 10. Access to internet connection that allows remote data entry and, for part B, video conferencing. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 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), short-acting insulin, fast acting insulin analogues or Toujeo® 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Steno Diabetes Centre Odense | Odense | |
Denmark | Syddansk Universitet | Odense | |
Germany | Studienzentrum Diabetespraxis Dr. Braun | Berlin | |
Germany | Klinische Forschung Dresden GmbH | Dresden | |
Germany | Velocity Clinical Research Leipzig GmbH | Leipzig | |
United Kingdom | FutureMeds Soho Health Centre | Birmingham | |
United Kingdom | Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool | |
United Kingdom | University Hospitals Leicester NHS Trust | Leicester | |
United Kingdom | NIHR Patient Recruitment Centre Newcastle, The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle |
Lead Sponsor | Collaborator |
---|---|
Mira Zuidgeest | IMI Trials@Home consortium, Innovative Medicines Initiative, Sanofi |
Denmark, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enrolment rates | Time to enrolment from Site activation until last participant enrolled | 32 weeks | |
Primary | Retention rates | Proportion of participants completing the study period | 6 months | |
Primary | Diversity | Various diversity aspects such as race, ethnicity, socioeconomic status, digital literacy, distance to health care professional, mobility. | 10 weeks | |
Primary | Participant satisfaction | Participant satisfaction measured using a questionnaire just after V2 (baseline), V6 and V9 (EOT) | 6 months | |
Primary | Site staff satisfaction | Site staff satisfaction measured using a questionnaire (after study initiation visit [SIV]), after 3 enrolled participants, after 3 participants completed Week 12 and after last patient last visit (LPLV). | 6 months | |
Primary | Study cost | Absolute cost per participant using a combination of prospective and retrospective measurements | complete trial duration | |
Primary | Time of AE (Adverse Event)/ SAE (Serious Adverse Event) occurence to collection | Time from event occurrence to collection AE/SAE in the eDiary or eCRF (electronic Case Report Form), whichever is applicable. | 6 months | |
Primary | Treatment adherence | Adherence to the daily insulin injection by means of eDiary analysis in percentage of days of documented intake until participant's EOT. | 6 months | |
Primary | Missing data | Proportion of missing data on the critical data points (Hb1Ac, Fasting Glucose, Participant satisfaction questionnaire) | 9 months | |
Primary | Query rate | Number of queries (both manual and automatic) per participant per arm. | 9 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |