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Effects of empagliflozin on plasma glucose in patients with HNF1A-MODY: a randomized, double-blind, crossover trial
EU CTIS ID: 2023-503760-17-00
What this study is testing
To investigate the glucose-lowering effect of empagliflozin 25 mg once-daily in patients with HNF1A-MODY.
- 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
- Informed consent
- Diabetes caused by a heterozygous mutation (pathogenic or likely pathogenic according to ACMG criteria) in the HNF1A-gene
- Age ≥18 years
- Hemoglobin A1c ≥48 mmol/mol
- Stable glucose-lowering treatment for 60 days prior to screening visit
- Treatment with at least one glucose-lowering drug (in a fixed dose)
You likely can't join if
- Breast feeding, pregnancy or intention to become pregnant
- Any concomitant disease or other condition(s) judged by investigators to be a safety concern or otherwise problematic for the conduct of the trial
- Inability to complete the study
- Not using adequate contraceptive methods if woman of child-bearing potential (intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections))
- History of acute and/or chronic pancreatitis
- Liver disease and/or alanine transaminase (ALT) and/or aspartate transaminase (AST) >2x upper normal serum levels
See the full eligibility criteria
- Informed consent
- Diabetes caused by a heterozygous mutation (pathogenic or likely pathogenic according to ACMG criteria) in the HNF1A-gene
- Age ≥18 years
- Hemoglobin A1c ≥48 mmol/mol
- Stable glucose-lowering treatment for 60 days prior to screening visit
- Treatment with at least one glucose-lowering drug (in a fixed dose)
- Breast feeding, pregnancy or intention to become pregnant
- Any concomitant disease or other condition(s) judged by investigators to be a safety concern or otherwise problematic for the conduct of the trial
- Inability to complete the study
- Not using adequate contraceptive methods if woman of child-bearing potential (intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections))
- History of acute and/or chronic pancreatitis
- Liver disease and/or alanine transaminase (ALT) and/or aspartate transaminase (AST) >2x upper normal serum levels
- Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2
- Anaemia (males blood haemoglobin <8.0 mmol/l and females <7.0 mmol/l)
- Known allergic reaction to study drug (empagliflozin)
- Treatment with an SGLT2-inhibitor within the last 60 days prior to screening visit
- Inability (judged by investigator) or unwillingness (of the potential participant) to abstain from a variable dosing regimen of glucose-lowering drugs (i.e., SU, repaglinide or insulin (bolus insulin) in a self-titrated regimen) during the study.
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.