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

NCT ID: NCT06333080

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-03-31

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 (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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Cohort

People with dysregulated type 2 diabetes on metformin treatment, which are naïve to second line antidiabetic treatment. These participants will be started on oral semaglutide, as a second line antidiabetic treatment, in addition to their treatment with metformin. The participants will be started on 3mg and the dose increased according to the label. The oral semaglutide will be administered once daily.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Vestergaard

Professor and Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Steno Diabetes Center North Denmark

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Nynne S Holdt-Caspersen, MSc

Role: CONTACT

nynnesh@hst.aau.dk

00 45 61 65 92 60

Facility Contacts

Mette Pilegaard Rasmussen, BSc

Role: primary

mpr@rn.dk

00 45 30 36 46 84

References

Holdt-Caspersen NS, Dethlefsen C, Hejlesen O, Christiansen E, Hangaard S, Vestergaard P, Jensen MH. Effect of Adherence to Oral Semaglutide on Glycemic Control in People With Type 2 Diabetes Treated With Metformin: Protocol for an Open-Label Clinical Trial. JMIR Res Protoc. 2025 Sep 23;14:e64899. doi: 10.2196/64899.

Reference Type: DERIVED

PMID: 40986866 (View on PubMed)

Other Identifiers

N-20220017

Identifier Type: -

Identifier Source: org_study_id