Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg once weekly versus placebo in participants with type 2 diabetes as add on to once-daily basal insulin with or without metformin

This research is testing a new combination medication called CagriSema for adults with type 2 diabetes. Participants will already be taking daily basal insulin, and some may also be taking metformin. The study aims to understand how effective and safe CagriSema is at improving blood sugar control (measured by HbA1c) and helping with weight loss over 40 weeks, compared to a placebo. We are also looking at its impact on other important health markers like body weight, blood pressure, and energy levels. This is a crucial step in potentially finding new and better ways to manage type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

Start

03 Apr 2024

Type 2 diabetes

What is this study about?

This study is about finding better ways to help people with type 2 diabetes manage their condition. Many people with type 2 diabetes already take medicines like insulin to help control their blood sugar. This research is testing a new combination medicine called CagriSema. It combines two different drugs, and we want to see if this combination works better than current treatments.

The main goal is to find out if CagriSema can help lower blood sugar levels more effectively over 40 weeks. We measure this using something called HbA1c, which gives an average of your blood sugar over the last few months. We're also very interested in whether this new medicine can help people lose weight, as weight management is often a big part of managing type 2 diabetes.

Beyond blood sugar and weight, the study will also look at other important health factors. This includes changes in blood pressure, cholesterol levels, and even how energetic participants feel. By looking at all these aspects, we can get a full picture of how CagriSema might benefit people with type 2 diabetes and improve their overall health and well-being.

Key takeaways

This study is for adults with type 2 diabetes.
It tests a new combination medicine, CagriSema, for blood sugar and weight.
Participants will continue their daily basal insulin and possibly metformin.
The study lasts 40 weeks and involves regular health check-ups.
It aims to find better ways to manage type 2 diabetes.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older.

You must have type 2 diabetes and currently be taking a type of insulin called basal insulin once a day. You might also be taking metformin, another common diabetes medication.

The research team will carry out some checks to make sure this study is right for you and that you meet all the health requirements.

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?
Do you currently take basal insulin every day?
Are you willing to attend regular clinic visits for 40 weeks?

Answer every question to see your result.

What does participation involve?

If you take part, you'll be assigned to either receive the new combination medicine (CagriSema) or a placebo (an inactive substance that looks like the real medicine). You'll inject this once a week. You will continue taking your usual daily basal insulin, and any metformin if you are currently on it. The study will last for 40 weeks.

You will have regular visits to the clinic, where the study team will monitor your health, take blood and urine samples, check your blood pressure and weight, and ask you about how you're feeling. They will also look at your blood sugar levels using different tests. You'll have follow-up appointments after the 40 weeks to make sure everything is okay.

Potential risks and benefits

Taking part in a clinical trial might offer you access to new treatments before they are widely available, and you'll receive close medical monitoring. However, there's always a chance the new treatment might not work for you, or it could have side effects. A placebo also means you might not receive the active treatment during the study. You're free to withdraw from the study at any time, for any reason, without it affecting your 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
Slovakia

Common questions

What is CagriSema?

CagriSema is a new combination medicine being tested for people with type 2 diabetes to help manage blood sugar and weight.

How long will the study last?

The main treatment part of the study will last for 40 weeks.

Will I still take my regular insulin?

Yes, you will continue to take your once-daily basal insulin during the study.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. This helps researchers compare the effects of the new medicine.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months.