Semaglutide and dapagliflozin in diabetic patients with different pathophysiology

niversity of gothenburg0 sites200 target enrollmentMarch 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

March 17, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of gothenburg

•Diabetes mellitus diagnosed according to the WHO criteria 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 \=48 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 a method of contraception that is reliable in the judgement of the Investigator
•Willingness to take injectable and oral medication
•Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•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
•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.