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Evaluation of controlled-ileal-release nicotinic acid tablets compared to placebo for treating people with prediabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study focuses on prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be diagnosed as diabetes. The study will test a medication called CIR-NA (controlled-ileal-release nicotinic acid), also known as niacin or vitamin B3, which is given as a film-coated tablet taken by mouth.

The study aims to determine if CIR-NA can help people with prediabetes achieve remission, which means returning their blood sugar levels to normal. The study will compare CIR-NA against placebo over a period of 26 weeks. During this time, researchers will monitor various aspects of blood sugar control, including fasting plasma glucose, glycated hemoglobin, and glucose tolerance.

Participants will receive either CIR-NA tablets or placebo tablets. The maximum daily dose of CIR-NA will be 200 mg, and the treatment will continue for approximately 6 months. The study will measure how well the medication works by checking if participants' prediabetes improves and whether it prevents progression to type 2 diabetes mellitus.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive either CIR-NA tablets (controlled-ileal-release nicotinic acid) or placebo tablets to take by mouth

    The treatment period will last for 26 weeks (approximately 6 months)

    You will need to take the tablets orally as prescribed

  2. Step 2

    Regular monitoring

    Your blood sugar levels will be checked regularly throughout the study

    The following tests will be performed:

    - Measurement of fasting blood sugar (taken when you haven't eaten)

    - Measurement of HbA1c (a test showing average blood sugar levels over the past 3 months)

    - Oral glucose tolerance test (a test measuring how your body processes sugar)

  3. Step 3

    Final evaluation

    At week 26, final tests will be conducted to evaluate:

    - Whether your prediabetes has improved

    - Your blood sugar levels through fasting tests

    - Your HbA1c levels

    - Your response to the oral glucose tolerance test

    The results will determine if the treatment has helped improve your prediabetes condition

Who can join the trial?

5 criteria

  • You must be between 18 and 79 years old
  • You can be either male or female
  • Your body mass index (BMI) must be 20 kg/m² or higher (BMI is a measure calculated from your weight and height)
  • You must have been diagnosed with prediabetes according to current European medical guidelines (prediabetes is a condition where blood sugar levels are higher than normal but not high enough to be diagnosed as diabetes)
  • You must not be part of any vulnerable population groups (such as prisoners, mentally disabled persons, or others unable to give informed consent)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Diagnosed with type 1 or type 2 diabetes (blood sugar levels higher than prediabetes range)
  • Currently pregnant or breastfeeding
  • Taking medications that affect blood sugar levels
  • History of serious heart conditions
  • Severe kidney or liver disease
  • Active cancer or ongoing cancer treatment
  • Participation in another clinical trial within the past 30 days
  • History of bariatric surgery (weight loss surgery)
  • Uncontrolled high blood pressure (above 140/90 mmHg)
  • Body Mass Index (BMI) below 18.5 or above 40
  • Inability to follow study procedures or attend scheduled visits
  • History of substance abuse in the past 12 months
  • Major psychiatric disorders that could interfere with the study
  • Allergies or sensitivity to study medication components
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Investigated drugs

  • Controlled-ileal-release nicotinic acid (CIR-NA)

    is a special form of nicotinic acid (also known as niacin or vitamin B3) that is designed to be released in a controlled manner in the small intestine. This medication is being studied for its potential to help people with prediabetes. The controlled release formulation is designed to minimize side effects while maintaining the therapeutic benefits. Nicotinic acid may help regulate blood sugar levels and improve insulin sensitivity.

  • Placebo

    is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used as a comparison to determine if the actual medication is effective.

What is already known about the treatment

CIR-NA (Controlled-ileal-release Nicotinic Acid) - An oral medication delivered in a special formulation that releases the active substance specifically in the ileal portion of the small intestine. This investigational drug belongs to the vitamin B3 (niacin) family and is being studied for its potential to treat prediabetes by improving insulin sensitivity and glucose metabolism. The controlled-release mechanism is designed to minimize the common side effects associated with immediate-release niacin while maintaining therapeutic effectiveness. Currently undergoing Phase II clinical trials, this medication represents a novel approach to preventing the progression from prediabetes to type 2 diabetes through its effects on lipid metabolism and glucose homeostasis.

Investigated diseases

  • Prediabetes

    A condition where blood sugar levels are higher than normal but not high enough to be diagnosed as type 2 diabetes. It occurs when cells become resistant to insulin or when the pancreas doesn't produce enough insulin to maintain normal blood glucose levels. People with prediabetes often have no clear symptoms, and the condition develops gradually. Prediabetes affects the body's ability to process sugar (glucose) properly. Without intervention, prediabetes can progress to type 2 diabetes over time.

  • Type 2 Diabetes Mellitus

    A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin. The condition develops when the body becomes resistant to insulin or doesn't produce enough insulin to maintain normal glucose levels. It typically develops gradually, and the body becomes increasingly unable to process sugar properly. The condition affects how the body metabolizes glucose, which is vital for energy production in cells.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519903-88-00Protocol codeCONCEPTEstimated enrolment390 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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