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DIACRON

Terminated

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

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

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

1

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

CGM time-in-range

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06333080
Org study IDN-20220017

Timeline

Milestones

Study start2023-11-01actual
Study first posted2024-03-27actual
Primary completion2025-07-29actual
Study completion2025-07-29actual
Last update posted2026-04-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

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.

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
3
Glycemic / diabetes
1
Patient-reported / QoL
1
Safety / tolerability / PK
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Time-in-Range (TIR)

Time frame:Change from baseline to three-month assessment

CGM time-in-range

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Treatment-Related Impact Measure for Diabetes (TRIM-D)

Time frame:Change from baseline to end of trial (three-month assessment).

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Occurrence of nausea or vomiting

Time frame:Reported during the entire trial duration, three months.

Nausea

descriptive, event

componentsNausea, Vomiting

Other (unclassified)

3 endpoints
Secondary/protocol endpoint

Pre-dose Fasting

Time frame:Time (minutes) elapsed from last registered food intake to registered medication intake.

descriptive

Secondary/protocol endpoint/low confidence

Post-dose Fasting

Time frame:Time (minutes) elapsed from registered medication intake to registered time of breakfast (start).

descriptive

Secondary/protocol endpoint/low confidence

Water Intake at Dosing Time

Time frame:Collected during the entire trial duration, three months.

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.