Diabetes Mellitus, Type 2DIACRONNCT06333080
The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin
An observational study of Diabetes Mellitus, Type 2, run by Aalborg University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- Type of treatment
- Pill or oral medicine
- How many people
- 1 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to 29 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Keywords
- Treatment Adherence and Compliance
- Medical subject headings
- Diabetes Mellitus, Type 2, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to three-month assessment
Secondary outcomes (5)
Pre-dose Fasting
Pre-dose fasting, defined as the time elapsed from last food intake in the evening to dosing time.
Measured: Time (minutes) elapsed from last registered food intake to registered medication intake.
Post-dose Fasting
Post-dose fasting, defined as time elapsed from dosing time to time of breakfast.
Measured: Time (minutes) elapsed from registered medication intake to registered time of breakfast (start).
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.
Measured: Reported during the entire trial duration, three months.
Water Intake at Dosing Time
Volume of water intake at dosing time.
Measured: Collected during the entire trial duration, three months.
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).
Measured: Change from baseline to end of trial (three-month assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Nov 2023
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it stopped: Due to recruitment issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Vestergaard, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333080
- Sponsor's protocol ID
- N-20220017
- Acronym
- DIACRON
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40986866
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06333080
- Acronym / sponsor ID
- DIACRON / N-20220017
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Treatment Adherence and Compliance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to recruitment issues.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time-in-Range (TIR)
Time frame: Change from baseline to three-month assessment
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.
5 secondary outcomes
Pre-dose Fasting
Time frame: Time (minutes) elapsed from last registered food intake to registered medication intake.
Post-dose Fasting
Time frame: Time (minutes) elapsed from registered medication intake to registered time of breakfast (start).
Occurrence of nausea or vomiting
Time frame: Reported during the entire trial duration, three months.
Water Intake at Dosing Time
Time frame: Collected during the entire trial duration, three months.
Treatment-Related Impact Measure for Diabetes (TRIM-D)
Time frame: Change from baseline to end of trial (three-month assessment).
Results and safety
The study was stopped early (reason given: Due to recruitment issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 40986866Holdt-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to recruitment issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-in-Range (TIR) (time frame: Change from baseline to three-month assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.