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Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide (DiaSpax)
EU CTIS ID: 2024-513416-98-00
What this study is testing
How do various antidiabetic drugs differ in their beneficial effects on adipose tissue function?
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The participant has provided written consent to participate in the study
- Age 30-70
- BMI ≥25
- HbA1c ≥42 mmol/mol
- 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.
You likely can't join if
- HbA1C ≥ 65 mmol/mol
- Insulin treatment
- Waran or NOAK-treatment
- Pregnancy, nursing or planned pregnancy
- Ongoing pregnancy (positive pregnancy test)
- Positive GAD or IA2 antibodies (Above reference range)
See the full eligibility criteria
- The participant has provided written consent to participate in the study
- Age 30-70
- BMI ≥25
- HbA1c ≥42 mmol/mol
- 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.
- HbA1C ≥ 65 mmol/mol
- Insulin treatment
- Waran or NOAK-treatment
- Pregnancy, nursing or planned pregnancy
- Ongoing pregnancy (positive pregnancy test)
- Positive GAD or IA2 antibodies (Above reference range)
- Hypersensitivity to the active substance or any of its excipients
- History of bladder cancer
- Uninvestigated macroscopic hematuria
- Low C-peptide/glucose ratio indicative of endogenous insulin deficiency (less than 2 measured as pmol/mg per dL)
- NT-proBNP 20% above the normal reference value
- Kidney disease/impairment (eGFR <60 ml/min)
- Liver disease and/or impairment (hepatic values over twice the upper reference value)
- Other severe chronic illness including ongoing cancer
- Established cardiovascular disease and/or heart failure
- Severe psychiatric condition
- Active alcoholism
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.