The goal of this clinical trial is to prevent the change from prediabetes (a pre-stage of type 2 diabetes mellitus (T2DM)) to T2DM in participants with prediabetes using oral CIR-NA (a nicotinic acid formulation that is designed to be released after reaching the ileum) which targeted the gut microbiota. The main questions it aims to answer are:
1. Is CIR-NA effective and does it prevent the change from prediabetes to T2DM? 2. Is the safety of CIR-NA that was observed in the Phase I clinical trial confirmed in subjects with prediabetes?
Researchers will compare CIR-NA to a placebo (a look-alike substance that contains no drug) in terms of an extended safety evaluation including safety laboratory assessments, physical examination, vital signs and 12-lead ECG.
Participants will:
Take CIR-NA or a placebo every day for 26-weeks. Visit the clinic at week 1 and subsequently once every 4 weeks for checkups and tests.
Receive standardized lifestyle recommendations regarding nutrition and physical activity during the intervention.
Male and female participants ≥ 18 to < 80 years of age (at the time of signing the informed consent).
Body mass index ≥ 20 kg/m².
Ability to understand and comply with the protocol.
Signed written informed consent.
Presence or a history of type 2 diabetes mellitus according to the current EASD/DDG guidelines.
Participants with relevant medical conditions (based on evaluation of medical history and screening assessments), unstable and uncontrolled underlying diseases, e.g., hypothyroidism, asthma, COPD or arterial hypertension, can be excluded per judgment of the Investigator.
Renal impairment (glomerular filtration rate <60 ml/min/1.73).
Impairment of hepatic function (one or more of liver enzymes alanine transaminase, aspartate transaminase and gamma glutamyl transferase [> 3-fold compared to normal range]).