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Not yet recruitingPHASE3INTERVENTIONAL

A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus

This research study is investigating new treatment options for adults living with type 2 diabetes. It's designed to understand how effective and safe two specific medications, Elecoglipron and Dapagliflozin, are when used individually compared to using them together. Researchers are particularly interested in people whose type 2 diabetes isn't well-controlled by lifestyle changes alone, or who are already taking other diabetes medications. By comparing these different approaches, the study hopes to find better ways to manage blood sugar levels and improve overall health for those with type 2 diabetes. All participants will be closely monitored for both benefits and any possible side effects throughout the study.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
2,000
Start
06 Jul 2026
Estimated completion
05 Jul 2028

What is this study about?

This study is a clinical trial, which means it's a careful medical research study involving people. The main goal of this particular study is to explore new ways to help adults with type 2 diabetes. We know that managing type 2 diabetes is very important for long-term health, and sometimes current treatments aren't enough for everyone. This study aims to find more effective and safe options.

Researchers are focusing on two medicines called Elecoglipron and Dapagliflozin. They want to see how well these medicines work to control blood sugar when given on their own, and also when they are given together as a combination. They compare these treatments to a "placebo," which looks just like the real medicine but contains no active drug. This helps the researchers understand the true effect of the actual study medicines.

The study is particularly looking for people whose type 2 diabetes isn't currently under good control with just diet and exercise, or those who are already taking other medicines for their diabetes but might need additional help. By carefully observing how people respond to these potential new treatments, the study hopes to provide valuable information that could lead to new ways to support individuals managing type 2 diabetes.

Key takeaways

  • This study explores new treatments for adults with type 2 diabetes.
  • It tests two medicines, Elecoglipron and Dapagliflozin, alone and in combination.
  • The goal is to find safer and more effective ways to manage blood sugar.
  • Participants will receive regular health checks and close medical supervision.
  • You can leave the study at any time without affecting your normal care.

Who may be eligible?

To be part of this study, you would need to be an adult, aged 18 or older, and have been diagnosed with type 2 diabetes for at least three months. Importantly, your diabetes should not be fully controlled by your current lifestyle or medications, meaning your blood sugar levels (measured by an HbA1c test) should be between 7% and 10.5%. You also need to have a body mass index (BMI) of 23 or higher, and your weight should have been stable for at least 90 days before checking if you can join.

There are certain reasons why someone might not be able to join. For example, if you have type 1 diabetes or a different kind of diabetes, or if you've had severe low blood sugar episodes recently. Also, if you've had certain serious health problems like severe heart failure, pancreatitis, or a history of specific cancers like medullary thyroid cancer, this study might not be suitable 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.

  1. Are you an adult aged 18 or older?
  2. Have you had type 2 diabetes for at least 3 months?
  3. Is your current diabetes management not fully controlling your blood sugar (HbA1c between 7% and 10.5%)?
  4. Do you have a BMI of 23 or higher, and has your weight been stable recently?
  5. Do you NOT have type 1 diabetes or specific severe heart or cancer conditions?
  6. Have you NOT had serious low blood sugar episodes recently?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of several treatment groups. This typically means you might receive Elecoglipron, Dapagliflozin, both medicines together, or a placebo (an inactive dummy drug). You'll take the study medication as instructed, and you'll have regular visits to the clinic over a period of time. These visits will involve various health checks, such as blood tests to measure your blood sugar levels (like HbA1c), weight measurements, and checks of your blood pressure and general health. You'll also be asked about any side effects you might experience. The total length of the study for each participant will be explained by the study team, but it will involve consistent follow-up to monitor your health and how you respond to the treatment.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as contributing to medical knowledge that could help future patients and possibly receiving close medical attention and a new treatment before it's widely available. However, there are also potential risks; you might experience side effects from the study medication, or the treatment might not work for you. Some participants may receive a placebo, meaning they won't get an active study drug. You will be fully informed of all known side effects and risks, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (178)

  • Research Site
    Verified postcode
    Huntsville, United States
  • Research Site
    Verified postcode
    Los Angeles, United States
  • Research Site
    Verified postcode
    Ontario, United States
  • Research Site
    Verified postcode
    Skokie, United States
  • Research Site
    Verified postcode
    Zachary, United States
  • Research Site
    Verified postcode
    Lutherville-Timonium, United States
  • Research Site
    Verified postcode
    Boston, United States
  • Research Site
    Verified postcode
    Raleigh, United States
  • Research Site
    Verified postcode
    Maumee, United States
  • Research Site
    Verified postcode
    Kingsport, United States
  • Research Site
    Verified postcode
    McKinney, United States
  • Research Site
    Verified postcode
    South Jordan, United States

Common questions

What is a Phase III study?

A Phase III study is a large research study that tests if a new treatment is safe and effective compared to existing treatments or a placebo before it's approved for wider use.

What does 'inadequately managed' mean?

It means that your current approaches, like diet and exercise alone or other medications, aren't fully controlling your type 2 diabetes as well as doctors would like.

What is a placebo?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active drug. It helps researchers understand the true effects of the actual medicine.

Will I know if I'm getting the real medicine or a placebo?

In most studies like this (called 'blinded' studies), neither you nor your study doctor will know which treatment you are receiving until after the study is over.

Can I continue my regular diabetes medication if I join?

The study will clearly tell you which of your current medications you can continue and which might need to be paused or adjusted during the trial period.

How to find out more

AstraZeneca Clinical Study Information Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Phase III Study to Investigate the Efficacy and Safety of …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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