Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

Sponsor
Region Skane
Study ID
NCT04451837
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Ozempic s.c. once weekly for 6 months
  • Dapagliflozin — DRUG
    Forxiga 10 mg p.o. once daily for 6 months

Study Details

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.

Key Dates

Start date
Sep 10, 2020
Status verified
Jul 2025
Primary completion
Dec 15, 2021
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: semaglutide
    Patients randomized to add semaglutide (Ozempic) will receive injection training at the study site and inject 0.25 mg subcutaneously once weekly during the first four weeks, followed by 0.5 mg weekly for the subsequent four weeks and finally 1.0 mg weekly throughout the study.
  • Active Comparator: dapagliflozin
    Those randomized to dapagliflozin will receive 10 mg orally once daily in addition to metformin.

Primary Outcome Measure

Hba1c [ Time Frame: 6 months ]

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