Effects of empagliflozin on plasma glucose in patients with HNF1A-MODY: a randomized, double-blind, crossover trial

Phase 1

Recruiting

• Conditions: Maturity-onset diabetes of the young type 3 (HNF1A-MODY); MedDRA version: 20.0Level: PTClassification code: 10075980Term: Monogenic diabetes Class: 100000004861; MedDRA version: 21.1Level: LLTClassification code: 10026948Term: Maturity-onset diabetes of the young Class: 10027433; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: CTIS2023-503760-17-00
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-27
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion 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)

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified