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Study on the Safety and Effectiveness of Utreglutide (GL0034) for Adults with Type 2 Diabetes Not Well Managed with Metformin or Lifestyle Changes

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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 effects of a new treatment for Type 2 diabetes, a condition where the body struggles to regulate blood sugar levels effectively. The treatment being tested is called GL0034, which is a solution for injection. It works as an analogue of the hormone glucagon-like peptide 1 (GLP-1) receptor agonist, which helps to control blood sugar levels. The study will compare the effects of GL0034 with a placebo, which is a solution that looks like the treatment but does not contain the active substance.

The purpose of the study is to investigate the safety and tolerability of GL0034 over a period of 16 weeks in adults with Type 2 diabetes who have not achieved adequate control of their condition with metformin or through diet and exercise. Participants will receive weekly injections of GL0034, and the study will monitor how well they tolerate the treatment and any side effects they may experience. The study will also look at changes in blood sugar levels, body weight, and other health markers.

Throughout the study, participants will be closely monitored for any gastrointestinal issues, as well as other potential side effects. The study aims to provide valuable information on how GL0034 can help manage Type 2 diabetes and improve the overall health of those living with this condition. The trial is expected to run until mid-2025, with recruitment starting in late 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of type 2 diabetes, and current treatment regimen.

    Participants must be between 18 and 70 years old, have a diagnosis of type 2 diabetes for at least 6 months, and meet certain health metrics.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics, including glycated hemoglobin (HbA1c) levels, body mass index, and other relevant health parameters.

  3. Step 3

    Treatment phase

    Participants receive the medication GL0034 through a subcutaneous injection once a week.

    The medication is available in different concentrations: 1 mg/ml, 3 mg/ml, and 4 mg/ml, with varying vial volumes.

    The treatment phase lasts for 16 weeks, during which the safety and tolerability of the medication are monitored.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, participants are monitored for any adverse effects, particularly gastrointestinal symptoms.

    Regular assessments are conducted to evaluate changes in health metrics such as glycated hemoglobin levels, daily plasma glucose, body weight, and lipid profile.

  5. Step 5

    Completion of the trial

    At the end of the 16-week treatment period, a final assessment is conducted to evaluate the overall impact of the medication on the participant's health.

    The study aims to gather data on the efficacy and safety of GL0034 in managing type 2 diabetes.

Who can join the trial?

5 criteria

  • Male and female patients aged between 18 and 70 years old can participate.
  • Participants must have been diagnosed with Type 2 diabetes mellitus for at least 6 months before joining the study. Type 2 diabetes is a condition where the body doesn't use insulin properly, leading to high blood sugar levels.
  • Participants should have a glycated hemoglobin (HbA1c) value between 6.5% and 8.5% at the time of screening. HbA1c is a blood test that shows the average level of blood sugar over the past 2 to 3 months.
  • Participants should be managing their diabetes with diet and exercise alone or taking a stable dose of metformin for at least 3 months before the screening. Metformin is a common medication used to control blood sugar levels in people with type 2 diabetes.
  • Participants must have a body mass index (BMI) between 28 and 50 kilograms per square meter (kg/m²). BMI is a measure that uses height and weight to estimate body fat.

Who cannot join the trial?

9 criteria

  • Having a different type of diabetes other than Type 2 diabetes.
  • Being outside the specified age range for the study.
  • Having a medical condition that the study team believes could interfere with the study.
  • Being pregnant or planning to become pregnant during the study period.
  • Having a history of allergic reactions to the study medication or similar medications.
  • Participating in another clinical trial at the same time.
  • Having a history of drug or alcohol abuse.
  • Having a serious illness that could affect participation in the study.
  • Being unable to follow the study procedures or instructions.
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Investigated drugs

GL0034 is an investigational medication being studied for its potential to help manage blood sugar levels in adults with type 2 diabetes. It is administered once a week through an injection under the skin. The study aims to evaluate how safe and well-tolerated this medication is when used with different dosing strategies over a period of 16 weeks. Participants in the trial are those whose diabetes is not adequately controlled with metformin or through diet and exercise alone.

What is already known about the treatment

GL0034 – This medication is administered as a once-weekly subcutaneous injection. It is currently in Phase 2 clinical trials, focusing on its efficacy and safety for treating adults with type 2 diabetes mellitus who have not achieved adequate control with metformin or lifestyle changes. The main therapeutic indication is to improve blood sugar levels in these patients. GL0034 works by enhancing insulin secretion and reducing glucose production in the liver, helping to regulate blood sugar levels. It is classified as an antidiabetic agent.

Investigated diseases

Type 2 diabetes mellitus – 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 health issues, including nerve damage, kidney problems, and vision issues. 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 associated with this condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513279-41-00Protocol codeSP-GL0034-02Estimated enrolment60 patientsSponsorSun Pharmaceutical Industries Limited

sourced from the EU Clinical Trials Register and site verification

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