Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333080
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-05
Brief Title:
The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin DIACRON - An Open-label Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIACRON
Brief Summary:
The objective of the trial is to investigate the effect of adherence to oral semaglutide dosing instructions on glycaemic control in people with type 2 diabetes which are dysregulated on metformin and naïve to second line antidiabetic treatment
Detailed Description:
The trial is a prospective non-interventional clinical trial with a duration of 12 weeks and will be conducted at Steno Diabetes Center North Denmark SDCNthe Endocrinology Outpatient Clinic Aalborg University Hospital
The participants of this non-interventional clinical trial are people with T2D which are dysregulated on metformin and naïve to second line antidiabetic treatment As these patients do not have glycaemic control despite treat-ment with metformin and lifestyle interventions the next recommended step in the treatment according to current guidelines is to add a second line antidiabetic to the treatment As the treatment according to guidelines should be individualised only patients which would start treatment with oral semaglutide independently of this trial are eligible for trial inclusion
The trial period starts with the first visit to the trial site and ends 12 weeks later with the second visit to the trial site A CGM baseline of each participant is collected prior to oral semaglutide initiation corresponding to the two first weeks of the trial period After oral semaglutide initiation CGM data physical activity time of dosing and water volume intake at dosing time are collected throughout the remaining trial period The participants are asked to report occurrences of nausea and vomiting including time duration and severity using a scale from 0-10 as previously described In addition the participants are asked to register time of breakfast at 3 time periods of the clinical trial
The patient-reported adherence and satisfaction of the diabetes treatment is assessed using the TRIM-D which is a questionnaire consisting of 28 questions divided into five subcategories treatment burden daily life diabetes management compliance and psychological health The participants are asked to electronically answer the TRIM-D questionnaire at the start and end of the trial The TRIM-D questionnaire is used in the validated Danish version Data on health belief is obtained by asking the participants to answer the questionnaire developed by Given et al and adapted by Becker and Janz The participants will furthermore be asked to answer a questionnaire on social support developed by Sarason et al The questionnaires on health belief and social support are translated to Danish
The participants of this non-interventional clinical trial are people with T2D which are dysregulated on metformin and naïve to second line antidiabetic treatment As these patients do not have glycaemic control despite treat-ment with metformin and lifestyle interventions the next recommended step in the treatment according to current guidelines is to add a second line antidiabetic to the treatment As the treatment according to guidelines should be individualised only patients which would start treatment with oral semaglutide independently of this trial are eligible for trial inclusion
The trial period starts with the first visit to the trial site and ends 12 weeks later with the second visit to the trial site A CGM baseline of each participant is collected prior to oral semaglutide initiation corresponding to the two first weeks of the trial period After oral semaglutide initiation CGM data physical activity time of dosing and water volume intake at dosing time are collected throughout the remaining trial period The participants are asked to report occurrences of nausea and vomiting including time duration and severity using a scale from 0-10 as previously described In addition the participants are asked to register time of breakfast at 3 time periods of the clinical trial
The patient-reported adherence and satisfaction of the diabetes treatment is assessed using the TRIM-D which is a questionnaire consisting of 28 questions divided into five subcategories treatment burden daily life diabetes management compliance and psychological health The participants are asked to electronically answer the TRIM-D questionnaire at the start and end of the trial The TRIM-D questionnaire is used in the validated Danish version Data on health belief is obtained by asking the participants to answer the questionnaire developed by Given et al and adapted by Becker and Janz The participants will furthermore be asked to answer a questionnaire on social support developed by Sarason et al The questionnaires on health belief and social support are translated to Danish
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None