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Study on the Effectiveness and Safety of Gliclazide MR, Dapagliflozin, and Metformin for Patients with Type 2 Diabetes Not Well Controlled with Dapagliflozin

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the treatment of Type 2 Diabetes, a condition where the body does not use insulin properly, leading to high blood sugar levels. The study will evaluate the effectiveness and safety of a medication called gliclazide MR in patients whose diabetes is not well controlled with another medication, dapagliflozin, with or without the addition of metformin. Gliclazide MR is a modified-release tablet, which means it releases the medication slowly over time. Dapagliflozin and metformin are also used to help control blood sugar levels in people with Type 2 Diabetes.

The purpose of this study is to see if the combination of gliclazide MR and dapagliflozin, with or without metformin, is better at reducing blood sugar levels compared to a placebo and dapagliflozin, with or without metformin. Participants in the study will be randomly assigned to receive either the combination of medications or a placebo. The study will last for 24 weeks, during which participants will take the medications by mouth as tablets. Throughout the study, participants will have regular check-ups to monitor their blood sugar levels and overall health.

By the end of the study, researchers aim to determine if the combination of gliclazide MR and dapagliflozin, with or without metformin, is more effective in lowering blood sugar levels than the current treatment options. This information could help improve treatment strategies for people with Type 2 Diabetes who are not achieving optimal blood sugar control with their current medications.

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

    Randomization and treatment initiation

    Upon joining the study, participants are randomly assigned to receive either the active treatment or a placebo. The active treatment consists of gliclazide MR in combination with dapagliflozin, with or without metformin. The placebo group receives a placebo in combination with dapagliflozin, with or without metformin.

    The medications are taken orally. Gliclazide MR is provided as a modified-release tablet, dapagliflozin as a film-coated tablet, and metformin as a film-coated tablet. The placebo is also administered orally.

  2. Step 2

    Treatment period

    The treatment period lasts for 24 weeks. During this time, participants continue their assigned treatment regimen. The goal is to assess the effectiveness of the treatment in reducing HbA1c levels, which is a measure of blood sugar control over time.

    Participants are monitored for changes in HbA1c and fasting plasma glucose (FPG) levels. The study also tracks the proportion of participants achieving specific HbA1c targets and any adverse events, such as hypoglycemic episodes or infections.

  3. Step 3

    End of treatment assessment

    At the end of the 24-week treatment period, participants undergo a final assessment. This includes measuring changes in HbA1c and FPG from the start of the study.

    The study evaluates the proportion of participants who reach the target HbA1c levels and those who require additional therapy. Vital signs, body weight, and laboratory measures are also assessed to ensure safety and effectiveness.

Who can join the trial?

9 criteria

  • Participants must have been diagnosed with Type 2 Diabetes for more than 6 months.
  • Participants must be 18 years or older.
  • Participants should have a Body Mass Index (BMI) between 25 and 40 kg/m2. BMI is a measure of body fat based on height and weight.
  • Participants must be on a stable diet and exercise routine.
  • Participants should be currently treated with one of the following:
    • Metformin alone at a stable daily dose of at least 1500 mg for at least 12 weeks before the first screening visit, with HbA1c levels between 8.0% and 11.5%. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
    • Dapagliflozin or Empagliflozin alone or in combination with metformin, with a stable daily dose for at least 12 weeks before the first screening visit, with HbA1c levels between 7.5% and 10.5%.
    • For the treatment period, participants must have HbA1c levels between 7.0% and 10.5%.
    • For the treatment period, participants must have Fasting Plasma Glucose (FPG) levels of 15 mmol/L or less. FPG is a test that measures blood sugar after fasting for at least 8 hours.
    • Participants previously treated with metformin alone will be withdrawn if their fasting capillary blood glucose is greater than 15 mmol/L, based on an average of 3 fasting tests, within the week before the third screening visit.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of diabetes other than Type 2 Diabetes.
  • Patients who have their diabetes well-controlled with their current medication.
  • Patients who are not taking dapagliflozin or are taking it with other medications not specified in the study.
  • Patients who are not within the age range specified for the study.
  • Patients who are part of a vulnerable population that the study does not include.
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Investigated drugs

  • Gliclazide MR

    is a medication used to help control blood sugar levels in people with type 2 diabetes. It works by increasing the amount of insulin released by the pancreas, which helps lower blood sugar levels. In this trial, it is being tested to see if it can improve blood sugar control when added to other diabetes medications.

  • Dapagliflozin

    is a medication that helps lower blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove sugar from the body through urine. This trial is examining its effectiveness in combination with other diabetes treatments.

  • Metformin

    is a common medication used to treat type 2 diabetes. It helps lower blood sugar levels by decreasing the amount of sugar produced by the liver and improving the body's response to insulin. In this study, it is used alongside other medications to see if it can help better control blood sugar levels.

What is already known about the treatment

Gliclazide MR – This medication is administered orally in the form of modified-release tablets. It is currently being studied in clinical trials for its effectiveness in treating type 2 diabetes, particularly in patients whose condition is not adequately controlled with dapagliflozin, with or without metformin. Gliclazide MR works by stimulating the pancreas to release more insulin, which helps lower blood sugar levels. It belongs to the pharmacological class of sulfonylureas, which are commonly used to manage blood sugar in type 2 diabetes.

Investigated diseases

Type 2 Diabetes – This is a chronic condition that affects the way the body processes blood sugar (glucose). In Type 2 Diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, nerves, and heart. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Managing blood sugar levels is crucial to prevent complications and maintain health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511408-18-00Protocol codeS005201-175Estimated enrolment347 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).