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← All trials/NCT04451837

Active not recruitingPhase 2

Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

Lead sponsor

Region Skane

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

200

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c ≥6.5%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04451837
Org study IDDIAB1

Timeline

Milestones

Study first posted2020-06-30actual
Study start2020-09-10actual
Primary completion2021-12-15actual
Last update posted2025-07-16actual
Study completion2026-12-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (1)

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.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Hba1c

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

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 6, 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 6, 2026 snapshot.