Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly s.c. Administered GL0034 in Adults with Type 2 Diabetes Mellitus Inadequately controlled on Metformin Or Diet and Exercise

This research study is looking into a new medicine called GL0034 for adults who have type 2 diabetes. If your diabetes isn't fully managed by metformin, diet, and exercise alone, this study might be for you. The medicine is given once a week as an injection under the skin. It's a 'Phase 2' study, which means we're still in the early stages of testing, mainly focusing on how safe the medicine is and if it has any side effects, especially tummy problems. We also want to see if it helps improve blood sugar levels, body weight, and other health markers. Some people will receive the new medicine, while others will get a dummy medicine (placebo) to fairly compare the results.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sun Pharmaceutical Industries Limited

Enrolment target

Start

26 Jul 2024

Type 2 diabetes mellitus

What is this study about?

This study is about a new potential medicine, called GL0034, for people living with type 2 diabetes. You might be interested if your current treatment, like metformin, or just diet and exercise, isn't quite enough to keep your blood sugar levels in a healthy range. We're testing GL0034 to see if it can help manage blood sugar, and importantly, to understand if it's safe and well-tolerated. The medicine is given once a week as an injection under the skin.

This is a 'Phase 2' study, which means it's an early stage of research. We're primarily checking for any side effects, especially those affecting the stomach or gut, like nausea or upset tummies. We'll be carefully tracking how often these happen and how severe they might be. We'll also be looking at whether GL0034 helps to lower blood sugar levels and improve other health measures like body weight and cholesterol.

By taking part, you could contribute to medical knowledge and help us understand if GL0034 could be a useful new treatment option for type 2 diabetes in the future. We want to make sure any new medicine is not just effective but also has an acceptable safety profile for patients.

Key takeaways

Tests new weekly injection (GL0034) for type 2 diabetes.
Aims to improve blood sugar control.
Mainly looking at safety and tummy-related side effects.
Compares GL0034 to a dummy medicine (placebo).
Suitable for adults whose diabetes isn't controlled by metformin or healthy living.
You'll get close medical monitoring and care.

Who may be eligible?

This study is looking for adults aged 18 or older who have type 2 diabetes. It's for people whose diabetes isn't fully controlled by metformin alone, or by changes to their diet and exercise habits.

To be considered, your doctor would need to confirm that you meet all the specific health requirements for the study. These typically include having certain blood test results within a particular range, and not having other health conditions that might make the new medicine unsafe for you or affect the study results.

It's important to remember that not everyone with type 2 diabetes will be able to join, even if they meet the basic age and treatment criteria. The research team will go through a full check to make sure the study is suitable and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have type 2 diabetes?
Is your diabetes not fully controlled by metformin, or diet and exercise alone?
Are you able to attend regular clinic visits?
Are you willing to have weekly injections?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned by chance to one of several groups. Some groups will receive different strengths of the new medicine GL0034, while another group will receive a 'placebo' – an injection that looks exactly like the study medicine but contains no active drug. Neither you nor your study doctor will know which one you are receiving.

You'll have regular visits to the clinic for check-ups, blood tests, and to receive your weekly injection. These visits will help the research team monitor your health, blood sugar levels, and any side effects. You'll likely be asked to keep a diary of any symptoms, especially those related to your stomach or gut. The total length of your involvement in the study, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Participating in research always has potential benefits and risks. A potential benefit of this study is that you might directly receive a new medicine that could help improve your diabetes management, blood sugar levels, and potentially your weight. You'll also receive close medical attention and monitoring throughout the study. However, there's always a risk that you might experience side effects from the new medicine, or that it might not be effective for you. As some participants will receive a placebo, your diabetes might not improve during the study. You will be fully informed about all known risks before you decide, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is GL0034?

GL0034 is a new medicine being tested for adults with type 2 diabetes to help manage blood sugar levels.

Why is it given as an injection?

GL0034 is designed to be given as a once-weekly injection under the skin because that's how this type of medicine works best in the body.

What does 'Phase 2 study' mean?

It means this is an early stage of testing. The main goals are to check the medicine's safety, look for side effects (especially tummy issues), and see if it helps blood sugar and other health measures.

Will I definitely get the new medicine?

No, you might receive the new medicine or a 'placebo' (a dummy medicine with no active drug) to allow for a fair comparison. It's decided by chance.

What if I want to stop participating?

You can withdraw from the study at any time, for any reason, without your medical care being affected.