Empagliflozin for Type 2 diabetes

Inclusion criteria

• {"criterion_text":"- The participant has provided written consent to participate in the study"}
• {"criterion_text":"- Age 30-70"}
• {"criterion_text":"- BMI ≥25"}
• {"criterion_text":"- HbA1c ≥42 mmol/mol"}
• {"criterion_text":"- Fertile women must use effective contraception throughout the study. Effective contraception includes any of the following: Combined hormonal contraceptives (estrogen and progestogen) that inhibit ovulation: oral, intravaginal, or transdermal; Progestogen-only contraceptives that inhibit ovulation: oral, injectable, or implantable; Intrauterine device (hormonal or copper); Bilateral tubal occlusion; Vasectomized partner; Sexual abstinence (refraining from heterosexual intercourse throughout the study). Women of childbearing potential need a negative pregnancy test at screening before randomization."}

Exclusion criteria

• {"criterion_text":"- HbA1C ≥ 65 mmol/mol"}
• {"criterion_text":"- Low C-peptide/glucose ratio indicative of endogenous insulin deficiency (less than 2 measured as pmol/mg per dL)"}
• {"criterion_text":"- NT-proBNP 20% above the normal reference value"}
• {"criterion_text":"- Kidney disease/impairment (eGFR <60 ml/min)"}
• {"criterion_text":"- Liver disease and/or impairment (hepatic values over twice the upper reference value)"}
• {"criterion_text":"- Other severe chronic illness including ongoing cancer"}
• {"criterion_text":"- Established cardiovascular disease and/or heart failure"}
• {"criterion_text":"- Severe psychiatric condition"}
• {"criterion_text":"- Active alcoholism"}
• {"criterion_text":"- Insulin treatment"}
• {"criterion_text":"- Waran or NOAK-treatment"}
• {"criterion_text":"- Pregnancy, nursing or planned pregnancy"}
• {"criterion_text":"- Ongoing pregnancy (positive pregnancy test)"}
• {"criterion_text":"- Positive GAD or IA2 antibodies (Above reference range)"}
• {"criterion_text":"- Hypersensitivity to the active substance or any of its excipients"}
• {"criterion_text":"- History of bladder cancer"}
• {"criterion_text":"- Uninvestigated macroscopic hematuria"}

Primary endpoints

• {"endpoint_text":"- Lipolysis is measured as basal and maximal isoprenaline-stimulated lipolysis in isolated adipocytes from the subcutaneous abdominal periumbilical adipose tissue and expressed as log10 ISO-stimulated/basal glycerol release ex vivo","definition_or_measurement_approach":"Measured as basal and maximal isoprenaline-stimulated lipolysis in isolated adipocytes from subcutaneous abdominal periumbilical adipose tissue, expressed as log10 ISO-stimulated/basal glycerol release ex vivo."}

Secondary endpoints

• {"endpoint_text":"- The cellular heterogeneity of adipose tissue (i.e., different adipocyte subtypes) is measured using qPCR of ADIPOQ/LEP in the same adipose tissue samples from which lipolysis is measured.","definition_or_measurement_approach":"Measured using qPCR of ADIPOQ and LEP on the same adipose tissue samples used for lipolysis measurements to assess adipocyte subtypes/cellular heterogeneity."}

Methods

• K1_ Recruitment Arrangements (document listed among recruitment documents)
• K2_ Recruitment Material_ Trialtree (document title indicates use of Trialtree digital recruitment)
• K2_ Recruitment Material_ Mail GP (mailing to general practitioners)
• K2_ Recruitment Material_Mail Cohort (mailing to cohort lists)
• K2_ Recruitment Arrangements_ Flyer (flyer distribution)
• K2_ Recruitment Arrangements_ Poster (poster distribution)
• K2_ Recruitment Material_ Mail GP and related recruitment PDFs associated with Denmark (associatedEntityId 180676) and Sweden (associatedEntityId 257671)

Sweden

Earliest CTIS Part Ii Submission Date

29-05-2024

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

545

Number Of Sites

1

Number Of Participants

60

Denmark

Earliest CTIS Part Ii Submission Date

12-02-2025

Latest Decision Or Authorization Date

14-11-2025

Processing Time Days

275

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}