Skip to content

Trial · Interventional

Active, not recruitingPhase 2Registry data

Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
200 participants (estimated)
Sponsor
Region Skane · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Sweden

Start
10 Sept 2020
Primary completion
15 Dec 2021
Completion
31 Dec 2026 (estimated)
First posted
30 Jun 2020
Last update posted
16 Jul 2025
Conditions
Type2 Diabetes

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202220242026
  1. Ph 2

    Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

    NCT04451837

    10 Sept 2020 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • DapagliflozinDrug

Arms2

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Hba1c

    Time frame · 6 months

    Registry description

    The primary endpoint will be the intraindividual change of HbA1c in response to semaglutide or dapagliflozin relative to baseline in the two patient groups.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

7 results

Randomized open-label trial of semaglutide and dapagliflozin in patients with type 2 diabetes of different pathophysiology.

Dwibedi et al. 2024Nature metabolismcited by 28

PMID 38177805PMC10822775DOI 10.1038/s42255-023-00943-3PUB-38177805

CC BY7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * • Diabetes mellitus based on prior documentation or treatment with anti-hyperglycemic medication or diagnosed according to the WHO criteria (random plasma glucose \>11.1 mmol/L or fasting glucose \>7.0 mmol/L or HbA1C ≥6.5%) and disease characteristics typical for SIDD or SIRD according to the ANDIS clustering * Ongoing metformin therapy with constant dose the last three months * Age 18 years or above * HbA1c ≥42 and \<91 mmol/mol * Women who are not postmenopausal and who have not undergone surgical sterilization must have no current pregnancy, which will be assessed by pregnancy test, must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose and must be willing to use highly effective birth control methods. Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. * Willingness to take injectable and oral medication * Written informed consent Exclusion Criteria: * • Type 1 diabetes, LADA, MODY, secondary diabetes or history of diabetic ketoacidosis * Anti-diabetic treatment other than metformin within 90 days prior to randomization or changed metformin dose within 90 days prior to randomization * Known acute cardiovascular event, e.g. transient ischemic attack, stroke, acute coronary syndrome, decompensated heart failure, coronary by-pass surgery or other coronary vessel intervention within 90 days prior to screening. * Heart failure NYHA class IV * History of acute or chronic pancreatitis * Known liver cirrhosis * Blood pressure above 170/110 mm Hg * A level of aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT), ALP or bilirubin of more than three times the upper limit of the normal range * Current chronic daily treatment with an oral steroid at a dose equivalent to oral prednisolone ≥10 mg (e.g., betamethasone ≥1.2 mg, dexamethasone ≥1.5 mg, hydrocortisone ≥40 mg) * Pregnancy or breast-feeding * Known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. * Estimated glomerular filtration rate \<45 ml/min/1,73 m2 or unstable or rapidly progressing renal disease * Participant unable to understand the study information herself or himself * Involvement in the planning and/or conduct of the study * Participation in other clinical trial which may affect the outcome of the present study * Any condition or treatment that in the judgment of the investigator makes it difficult or unsafe to participate in the study

PepBank is a research reference. Talk to a doctor before you use any peptide.