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Study on the Effects of AZD5004 and Semaglutide for Adults with Type 2 Diabetes

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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 medication called AZD5004 in adults with Type 2 Diabetes Mellitus. The study aims to evaluate how well AZD5004 helps control blood sugar levels compared to a placebo. Participants will take the medication once daily in the form of a film-coated tablet for a period of 26 weeks.

In addition to AZD5004, the study will also involve the use of Rybelsus tablets, which contain the active substance semaglutide. These tablets come in doses of 3 mg, 7 mg, and 14 mg. The purpose of including Rybelsus is to compare its effects with those of AZD5004 and the placebo. The study will monitor changes in blood sugar levels, body weight, and other health indicators over the course of the trial.

Participants will be randomly assigned to receive either AZD5004, Rybelsus, or a placebo. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This approach helps ensure that the results are unbiased and reliable. The study will provide valuable information on the safety and effectiveness of AZD5004 in managing Type 2 Diabetes Mellitus.

The research process

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

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of Type 2 Diabetes Mellitus for at least six months, and other health criteria.
The assessment ensures that the HbA1c level is between 7.0% and 10.5%, and that the patient has been managing diabetes with diet, exercise, or stable medication for at least one month.
Step 2
Randomization
Participants are randomly assigned to receive either the study medication AZD5004, a placebo, or an active comparator such as Rybelsus tablets.
The study is double-blind, meaning neither the participants nor the researchers know who receives which treatment.
Step 3
Medication administration
Participants take the assigned medication orally once daily for a duration of 26 weeks.
The medications include AZD5004 film-coated tablets or Rybelsus tablets in dosages of 3 mg, 7 mg, or 14 mg, depending on the group assignment.
Step 4
Monitoring and follow-up
Regular monitoring of blood sugar levels and other health indicators occurs at specified intervals: baseline, 4 weeks, 12 weeks, 16 weeks, and 26 weeks.
The primary goal is to observe changes in HbA1c levels, while secondary goals include changes in fasting glucose and body weight.
Step 5
Completion of study
At the end of the 26-week period, a final assessment is conducted to evaluate the overall effects of the treatment.
The study aims to determine the efficacy, safety, and tolerability of AZD5004 compared to placebo and other treatments.

Who can join the trial?

7 criteria

Adults who are **18 years or older**.
Have been diagnosed with **Type 2 Diabetes Mellitus (T2DM)** for at least **6 months**. T2DM is a condition where the body doesn't use insulin properly, leading to high blood sugar levels.
Have a blood test result called **HbA1c** between **7.0% and 10.5%**. HbA1c is a measure of average blood sugar levels over the past 2 to 3 months.
Manage their diabetes with **diet and exercise alone** or with a stable dose of **metformin** or an **SGLT2 inhibitor** for at least one month before the study. Metformin and SGLT2 inhibitors are medications used to help control blood sugar levels.
Have a **body mass index (BMI)** of **23 kg/m² or higher**. BMI is a number calculated from a person's weight and height, used to assess if they have a healthy body weight.
Have had a **stable body weight** for **3 months** before joining the study, meaning no more than a **5% change** in body weight.
Are able to **understand and sign a consent form** and follow the study's rules and requirements.

Who cannot join the trial?

8 criteria

Patients with a history of severe allergic reactions to any of the study medications.
Individuals who have had a recent heart attack or stroke.
Patients with uncontrolled high blood pressure.
Individuals with severe liver or kidney disease.
Patients who are currently pregnant or breastfeeding.
Individuals who are participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Individuals with any other medical condition that the study doctor believes would make participation unsafe.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CRS Clinical Research Services Mannheim GmbH
Verified
Mannheim, Germany
Hospital Universitario Virgen De La Victoria
Verified
Malaga, Spain
Semmelweis University
Responsive
Budapest, Hungary

Trial locations

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Investigated drugs

AZD5004 is a medication being studied for its potential to help control blood sugar levels in adults with Type 2 Diabetes Mellitus. The trial aims to assess how effective, safe, and tolerable this medication is compared to a placebo.

What is already known about the treatment

AZD5004 – AZD5004 is an investigational medication administered orally, currently being studied in clinical trials for its potential use in managing Type 2 Diabetes Mellitus. It is in the Phase IIb stage of clinical trials, where its efficacy, safety, and tolerability are being evaluated. The main therapeutic indication for AZD5004 is to improve glycemic control in adults with Type 2 Diabetes. At the molecular level, AZD5004 works by modulating specific pathways involved in glucose metabolism, helping to lower blood sugar levels. It is classified pharmacologically 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 this disease, 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 problems, including nerve damage, kidney issues, and vision problems. The progression of Type 2 Diabetes Mellitus can be gradual, often starting with insulin resistance and eventually leading to decreased insulin production. Lifestyle factors such as diet, physical activity, and weight management play a significant role in the development and progression of this condition. Regular monitoring of blood sugar levels is crucial to managing the disease effectively.