Investigating how well patients with type 2 diabetes follow oral semaglutide dosing instructions
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
This study is testing how well people with type 2 diabetes follow the dosing instructions for a new oral medication called semaglutide to see if it helps them manage their blood sugar better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT06333080 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to assess the impact of adherence to oral semaglutide on glycaemic control in individuals with type 2 diabetes who are not achieving adequate control with metformin alone. Conducted over 12 weeks at Steno Diabetes Center North Denmark, participants will have their continuous glucose monitoring (CGM) data collected alongside reports of physical activity and dosing habits. The study focuses on patients who are new to second-line antidiabetic treatment and will evaluate their experiences with the medication, including any side effects like nausea and vomiting.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with type 2 diabetes for at least one year, currently treated with metformin, and who are naïve to second-line antidiabetic treatments.
Not a fit: Patients with other types of diabetes, those currently on other glucose-lowering medications, or individuals with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how adherence to medication impacts glycaemic control, potentially leading to better management strategies for type 2 diabetes.
How similar studies have performed: While this approach is not widely tested, similar studies focusing on medication adherence in diabetes management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aalborg
- Steno Diabetes Center North Denmark — Aalborg, Denmark (Recruiting)
Study contacts
- Study coordinator: Nynne S Holdt-Caspersen, MSc
- Email: nynnesh@hst.aau.dk
- Phone: 00 45 61 65 92 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.