The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin

Diabetes Mellitus, Type 2 Clinical Trial

— DIACRON  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333080
• Other study ID #: N-20220017
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Aalborg University Hospital
• Contact: Nynne S Holdt-Caspersen, MSc
• Phone: 00 45 61 65 92 60
• Email: nynnesh[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 (SDCN)/the 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of type 2 diabetes for at least 1 year.

• HbA1c of 53-75 mmol/mol at ???.

• Treated with metformin for at least 1 year.

• Can understand and read Danish.

• Can use a smartphone, as well as the devices used in the clinical trial.

• Signed informed consent.

Exclusion Criteria:

• HbA1c value recorded less than 3 months prior to inclusion in trial.

• Current or prior treatment with other glucose-lowering medications than metformin.

• Cardiovascular disease or kidney disease which would indicate use of other second line treatments such as SGLT2 inhibitors or s.c. GLP1 receptor agonists (see also current guidelines https://endocrinology.dk/nbv/diabetes-melitus/behandling-og-kontrol-af-type-2-diabetes /).

• Other types of diabetes than type 2 diabetes.

• Participation in other trials.

• Pregnancy or breastfeeding.

• Known retinopathy.

• Known allergy to semaglutide.

• Major surgery planned during the trial period.

• Cancer diagnosis within five years prior to inclusion.

• Personal or family history of medullary thyroid carcinoma.

• Multiple endocrine neoplasia syndrome type 2.

• Conditions, which the investigators deem to render the participant unfit for inclusion in the trial, including a physical or cognitive inability to participate in the trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center North Denmark	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-in-Range (TIR)	Change from baseline to end-of-study in time-in-range (TIR) derived from CGM calculated in accordance with the International Consensus on Use of Continuous Glucose Monitoring.	Change from baseline to three-month assessment
Secondary	Pre-dose Fasting	Pre-dose fasting, defined as the time elapsed from last food intake in the evening to dosing time.	Time (minutes) elapsed from last registered food intake to registered medication intake.
Secondary	Post-dose Fasting	Post-dose fasting, defined as time elapsed from dosing time to time of breakfast.	Time (minutes) elapsed from registered medication intake to registered time of breakfast (start).
Secondary	Occurrence of nausea or vomiting	Occurrence of nausea or vomiting incl. timing, duration, and severity. Nausea and vomiting severity are reported on a scale from 0-10 with 0 being no nausea/vomiting and 10 being the worst imaginable nausea/vomiting, similar to the scale of nausea severity described by Leere, et al.	Reported during the entire trial duration, three months.
Secondary	Water Intake at Dosing Time	Volume of water intake at dosing time.	Collected during the entire trial duration, three months.
Secondary	Treatment-Related Impact Measure for Diabetes (TRIM-D)	Patient-reported satisfaction and adherence of treatment reported as the total score of the treatment-related impact measure for diabetes (TRIM-D).	Change from baseline to end of trial (three-month assessment).