A Phase II, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral controlled-ileal-release nicotinic acid (CIR-NA) for inducing remission in subjects with prediabetes

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519903-88-00

Acronym

CONCEPT

Enrollment

390

Registered

2025-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

Brief summary

Remission of prediabetes at week 26

Detailed description

Progression of prediabetes to type 2 diabetes mellitus at week 26, Fasting plasma glucose levels at week 26, Glycated haemoglobin (HbA1c) levels at week 26, 2-h oral Glucose Tolerance Test levels at week 26

Interventions

DRUGCIR-NA (controlled-ileal-release nicotinic acid)

DRUGPlacebo CIR-NA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Remission of prediabetes at week 26	—

Secondary

Measure	Time frame
Progression of prediabetes to type 2 diabetes mellitus at week 26, Fasting plasma glucose levels at week 26, Glycated haemoglobin (HbA1c) levels at week 26, 2-h oral Glucose Tolerance Test levels at week 26	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026