Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of once-weekly semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine vs titrated insuline glargine in participants with type 2 diabetes and overweight

This study is for people with type 2 diabetes who are also overweight. We are testing how a weekly injection called semaglutide (also known as Ozempic) works when added to insulin glargine (Lantus). Some participants will get a reduced dose of insulin plus semaglutide, while others will have their insulin dose adjusted as usual. The main goal is to see how much blood sugar levels (measured by HbA1c) change over about 40 weeks. We'll also look at changes in weight, the amount of insulin needed, and how happy people are with their treatment. This is a Phase 3 study, meaning it's a large trial to confirm the treatment works well and is safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

398

Start

06 Aug 2024

Participants with T2D and overweight

What is this study about?

This research study is looking into a new way to help people with type 2 diabetes who are also overweight. Many people with type 2 diabetes use insulin to help keep their blood sugar levels in a healthy range. However, some insulin treatments can sometimes lead to weight gain, which can be a concern for those who are already overweight.

In this study, we are focusing on a medicine called semaglutide, also known as Ozempic. This medicine is given as a weekly injection and is already used for type 2 diabetes. We want to see if adding semaglutide to a reduced dose of another insulin called insulin glargine (Lantus) works better than just using insulin glargine on its own, with its dose adjusted as needed. The main idea is to see if this combination can improve blood sugar control while potentially allowing for a lower insulin dose.

The study will compare these two approaches over about 40 weeks. We'll be carefully checking changes in blood sugar levels, weight, and the amount of insulin people need. We'll also ask participants how they feel about their treatment, as patient satisfaction is an important part of managing long-term conditions like diabetes.

Key takeaways

Aims to improve blood sugar control in type 2 diabetes and overweight.
Tests a weekly injection (Ozempic) with a lower dose of insulin (Lantus).
Compares this new approach with standard insulin treatment.
Checks for changes in blood sugar, weight, and patient satisfaction.
Participation involves regular clinic visits for about 40 weeks.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. To join, you must have type 2 diabetes and also be considered overweight.

There will be other detailed criteria that your doctor will check. These might include how long you've had diabetes, what other medications you're taking, and your general health. It's important that your doctor reviews all your medical information to make sure this study is right and safe for you.

For example, if you have certain other health conditions, or if your diabetes is managed in a specific way that doesn't fit the study's requirements, you might not be able to take part. The study team will explain everything clearly during your initial assessment.

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 currently considered overweight?
Are you able to commit to regular clinic visits for about 40 weeks?
Are you comfortable with taking injections if required for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be in the study for about 40 weeks. During this time, you would have regular visits to the clinic for check-ups. These visits will involve blood tests to measure your blood sugar (HbA1c) and other health markers, and your weight will be checked. You would receive either the weekly semaglutide injection along with a reduced dose of insulin glargine, or your insulin glargine dose would be adjusted as needed. All study medicines will be provided. You would also be asked to fill out questionnaires about how you feel about your treatment. After the 40 weeks of treatment, there will likely be a follow-up visit to see how you are doing.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You might benefit from closer medical attention and potentially a new treatment approach that could improve your blood sugar control or help with weight management. However, there's a chance the study treatments might not work for you, or you could experience side effects. All possible side effects will be fully explained before you agree to take part. Remember, joining is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

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Unverified
Czechia
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Unverified
Portugal
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Unverified
Spain
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Unverified
Greece
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Unverified
Slovakia
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Unverified
Romania
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Unverified
Italy

Common questions

What is HbA1c?

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

What's the difference between this study and my usual diabetes care?

This study uses specific types and doses of medication, and you'll have more frequent check-ups and tests than usual. Your regular care might involve different medications or fewer appointments.

Will I know which treatment I'm getting?

In many studies like this, participants don't know whether they are getting the new treatment combination or the standard approach. This helps to make sure the results are fair and unbiased.

What are Ozempic and Lantus?

Ozempic (semaglutide) is an injection taken once a week for type 2 diabetes. Lantus (insulin glargine) is a type of insulin often taken once a day to help lower blood sugar.

What does 'overweight' mean for this study?

The study will have specific criteria for being 'overweight', usually based on your Body Mass Index (BMI). Your doctor will be able to tell you if you meet this requirement.