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

NCT06333080 | Terminated

• 1 other identifier: N-20220017
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Treatment Adherence and Compliance

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to three-month assessment

Secondary Outcomes (5)

• Pre-dose Fasting

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

• Post-dose Fasting

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

• Occurrence of nausea or vomiting

  Reported during the entire trial duration, three months.

• Water Intake at Dosing Time

  Collected during the entire trial duration, three months.

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

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Personal or family history of medullary thyroid carcinoma.
• Multiple endocrine neoplasia syndrome type 2.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Steno Diabetes Center North Denmark

Aalborg, 9000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40986866 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Endocrinologist

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 27, 2024
• Study Start: November 1, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

DK (1)