Clinical trial NCT06333080: The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: Treatment Adherence and Compliance
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All included participants must have type 2 diabetes, which is dysregulated on metformin and be naïve to second line antidiabetic treatment. Participants are regarded as dysregulated if a HbA1c of 53-75 mmol/mol has been recorded 3 months prior to trial inclusion and again at the first visit. As the participants do not have glycaemic control, the next step in the treatment is to initiate a second line antidiabetic treatment, which in this clinical trial is oral semaglutide. Thus, eligible participants for this study should have a second line antidiabetic treatment added to their metformin treatment, regardless of participation in this study. The participants will continue their metformin treatment and treatment with oral semaglutide will be initiated two weeks after trial start.

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.

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.

Primary outcomes:
measure: Time-in-Range (TIR)
timeFrame: Change from baseline to three-month assessment
Secondary outcomes:
measure: Pre-dose Fasting
timeFrame: Time (minutes) elapsed from last registered food intake to registered medication intake.
measure: Post-dose Fasting
timeFrame: Time (minutes) elapsed from registered medication intake to registered time of breakfast (start).
measure: Occurrence of nausea or vomiting
timeFrame: Reported during the entire trial duration, three months.
measure: Water Intake at Dosing Time
timeFrame: Collected during the entire trial duration, three months.
measure: Treatment-Related Impact Measure for Diabetes (TRIM-D)
timeFrame: Change from baseline to end of trial (three-month assessment).
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Steno Diabetes Center North Denmark
Study officials:
References: