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Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

StatusActive, Not Recruiting
PhasePhase 2
Started2020-09-10
View on ClinicalTrials.gov ↗

Amendment history

2025-07-13
Study Status v5
Completion date2022-12-31→2026-12-31
2022-10-19
Study Status, Study Description, Eligibility v4
Start date2020-06-15→2020-09-10
Eligibility criteriarevised
[...] ant dose the last three months Age 18 years or above HbA1c ≥4842 and <91 mmol/mol Women who are not postmenopausal and who h [...]
Study descriptionrevised
[...] ll recruit 200 patients from the ANDIS registry with HbA1c ≥4842 mmol/mol on metformin monotherapy. Half of them will have S [...]
2022-03-25
Study Status v3
Primary completion dateestimated 2021-12-31→confirmed 2021-12-15
Completion date2021-12-31→2022-12-31
2021-09-21
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2021-07-31→2021-12-31
Study sitesdetails revised at 1 of 1 site
2020-06-30
Study Status, Study Description v1
Study description+44 characters
[...] o are at different ends of the pathophysiological spectrum. WeThe investigators will recruit 200 patients from the ANDIS registry with HbA1 [...] e or dapagliflozin for six months in addition to metformin. WeThe investigators will recruit participants on metformin monotherapy with sta [...] heir regular physician) is maintained throughout the study; wethe willinvestigatorswill correct for metformin dose in the analyses. Patients random [...]
2020-06-25
Original filing
Region Skane
146 trials monitored
See 5 trials at risk
Diabetes
4,247 trials monitored
See 176 trials at risk
Type 2 Diabetes
2,082 trials monitored
See 101 trials at risk
Current anti-diabetic treatment fails to stop the progressive course of the disease. Recent studies have revealed a surprisingly high variability in the diabetic phenotype. The investigators propose that anti-diabetic treatment should ideally target the underlying pathophysiology of each individual patient. The investigators will therefore test whether the effect of two approved anti-diabetic drugs differs between individuals at different ends of the pathophysiological spectrum: 1) patients with poor insulin secretion, here termed SIDD and 2) patients with high insulin resistance, here termed SIRD. The study may open up a new avenue for more precise treatment of diabetic patients that would be of immediate clinical relevance.
Trial Details
NCT Number NCT04451837
Lead Sponsor Region Skane
Collaborators: Göteborg University
Conditions Type2 Diabetes
Enrollment 200 participants
Start Date 2020-09-10
Primary Completion 2021-12-15 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-16