Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase Ilb, Randomized, Double-blind, Placebo controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults with Type 2 Diabetes Mellitus

Researchers are studying a new drug, AZD5004, for adults who have Type 2 Diabetes. This study aims to find out if AZD5004 is effective at lowering blood sugar levels, measured by something called HbA1c, over 26 weeks (about six months). They also want to make sure it's safe and that people can take it without too many problems. To do this, some people will get the new medicine, others will get a common diabetes drug called Rybelsus, and some will get a dummy pill (placebo) that looks the same but contains no active medicine. This helps them understand the true effects of the new drug. The study will also look at other things like changes in weight and daily blood sugar readings.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

AstraZeneca AB

Enrolment target

118

Start

15 Nov 2024

Type 2 Diabetes Mellitus

What is this study about?

This study is investigating a new medication, called AZD5004, for adults who have Type 2 Diabetes. Doctors and researchers want to understand how well this new medicine works to control blood sugar levels, specifically looking at a measurement called HbA1c. HbA1c gives an average picture of your blood sugar over the past two to three months. They also want to make sure the medicine is safe to use and that people can take it without too many uncomfortable side effects.

The study will compare AZD5004 to a commonly used diabetes medication called Rybelsus, as well as a 'placebo'. A placebo is a dummy pill that looks exactly like the study medicine but contains no active ingredients. This comparison is important because it helps researchers clearly see what effects the new medicine has, beyond what might happen naturally or through the 'placebo effect' (where people feel better just because they think they are getting treatment).

Over 26 weeks, or about six months, the research team will regularly check participants' HbA1c levels to see if AZD5004 helps lower them. They will also keep an eye on other health markers, such as daily blood sugar levels and any changes in body weight. This will help them get a full picture of how AZD5004 might help people manage their Type 2 Diabetes.

Key takeaways

Tests a new medicine (AZD5004) for Type 2 Diabetes.
Compares it to an existing drug (Rybelsus) and a dummy pill (placebo).
Focuses on lowering blood sugar (HbA1c) over 26 weeks.
Also checks safety, side effects, and changes in body weight.
Participation involves regular clinic visits and health checks.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older.

Both men and women can join the study. Further details about your health and your current diabetes treatment will be checked by the study team to see if you are a good fit for this particular research.

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?
Are you able to attend regular clinic visits?
Are you willing to take oral medication as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine (AZD5004), a current diabetes medicine (Rybelsus), or a dummy pill (placebo). No matter which group you're in, the pills would look the same. You would have regular visits to the clinic over a period of 26 weeks (about six months). These visits would include health checks, blood tests to measure your blood sugar levels (like HbA1c and fasting glucose), and discussions about how you're feeling and any effects you might be experiencing. Your weight would also be monitored. Throughout the study, you would be carefully looked after by the study team. After the initial 26 weeks, there would likely be follow-up checks.

Potential risks and benefits

Taking part in a study like this might offer you access to a new medicine before it's widely available, and your health will be closely monitored by medical professionals. However, there's no guarantee the new medicine will help you, and it could cause side effects, just like any medication. The dummy pill (placebo) won't have any medical effect but helps researchers understand the true benefits of the active drugs. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Hungary
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Unverified
Germany
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Unverified
Poland
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Unverified
Spain
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Unverified
Slovakia

Common questions

What is Type 2 Diabetes?

Type 2 Diabetes is a common condition where the body doesn't produce enough insulin, or the insulin it does produce doesn't work properly, leading to high blood sugar levels.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's an important measure for managing diabetes.

What does 'placebo' mean?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active ingredients. It helps researchers compare the real effects of the drug.

Will I know if I'm getting the new medicine or the dummy pill?

No, this is a 'double-blind' study, meaning neither you nor the study doctors will know which treatment you are receiving until the study is over. This helps keep the results fair.

How long will the study last for me?

Your active participation in the main part of the study will last for 26 weeks, which is about six months. There may be follow-up after this.