Active not recruitingPHASE2INTERVENTIONAL

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

This research study is investigating a new medication, CagriSema, for individuals living with type 2 diabetes and ongoing pain caused by nerve damage due to their diabetes. Participants will be randomly assigned to receive either CagriSema, the active study medicine, or a 'dummy' medicine known as a placebo. This helps researchers understand the true effects of CagriSema. The study will last for around 10 months for each person involved. The main goal is to see if CagriSema can help improve both diabetes management and reduce nerve pain, which doctors can't currently prescribe. Your involvement could help us learn more about treating these conditions.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Novo Nordisk A/S

Enrolment target

142

Start

29 Jan 2025

Estimated completion

21 Aug 2026

Diabetes Mellitus, Type 2 Diabetic Peripheral Neuropathy

What is this study about?

This research is looking into a new medicine called CagriSema. It's designed for people who have both type 2 diabetes and also experience pain caused by nerve damage, a common problem known as diabetic peripheral neuropathy. Nerve damage pain can be really challenging, and managing type 2 diabetes well is also very important for long-term health.

In this study, some people will receive CagriSema, while others will get a 'dummy' medicine, called a placebo. This is a common and important way to test new medicines. By comparing the effects of CagriSema to a placebo, researchers can figure out if the new medicine is actually making a difference to your diabetes and your pain, or if any changes are just due to other factors. You won't know whether you are getting the active medicine or the placebo, and neither will your study doctor, which helps keep the results fair and unbiased.

CagriSema isn't a medicine that doctors can prescribe yet; it's still being tested. The aim of this study is to gather information about how well it works and if it's safe. Taking part in this study could help scientists and doctors understand better ways to treat type 2 diabetes and the nerve pain it can cause, potentially helping many people in the future.

Key takeaways

This study is testing a new medicine, CagriSema, for type 2 diabetes and nerve pain.
It compares CagriSema to a 'dummy' medicine (placebo).
Each participant will be in the study for about 10 months.
Taking part involves regular health checks and blood tests.
This medicine is not yet available from your doctor.
Your involvement could help improve future treatments for these conditions.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a body mass index (BMI) of 25 or higher. You must have been diagnosed with type 2 diabetes for at least six months. If you're already taking medicines for your diabetes, you should have been on a stable dose for at least three months before the study starts. This includes oral tablets, insulin, or a combination of both.

You also need to have pain from diabetic nerve damage that you've experienced for at least three months. Any pain treatments you're currently using the for nerve pain should also have been stable for at least three months. Your average blood sugar level (HbA1c) needs to be within a specific range – not too high and not too low.

There are some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant, you cannot take part. If you are able to become pregnant, you must be using effective contraception. You also can't have used certain other diabetes or weight-loss medicines, or strong pain relievers like some opioids, cannabis-based products, or certain anxiety medicines, within a specific time before the study.

Quick self-check

Are you 18 years old or older?
Do you have type 2 diabetes (diagnosed over 6 months ago)?
Do you have ongoing pain from diabetic nerve damage (for at least 3 months)?
Is your current diabetes and pain medication stable (for at least 3 months, if applicable)?
Are you able to use contraception if you could become pregnant?
Have you avoided certain other diabetes or strong pain medications recently?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it will involve a series of visits to the study clinic over approximately 10 months. During these visits, the study team will carefully monitor your health and how you're responding to the treatment. This will include regular blood tests to check your blood sugar levels and other health markers. They will also assess your pain levels and any changes you experience. You will be given either the study medicine, CagriSema, or a placebo, which you will take as instructed by the study team. They will explain exactly how and when to take it. Throughout the study, you'll have close contact with the medical team, who will be there to answer your questions and address any concerns. There will also be follow-up appointments after you finish taking the study medicine to ensure your well-being.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new investigational medication that might improve your diabetes and nerve pain, and having close medical monitoring. However, there are also potential risks, including side effects from the study medicine, which will be carefully explained to you. It's also possible you could receive the placebo and not the active medicine. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

eStudySite
La Mesa, United States
Linda Vista Health Care Ctr
San Diego, United States
My Preferred Research
Miami, United States
New Horizon Research Center
Miami, United States
Renstar Medical Research
Ocala, United States
Foot & Ankle Center of Illinois
Springfield, United States
Velocity Clinical Research Rockville
Rockville, United States
Amicis Centers of Clinical Research
St Louis, United States
DM Clinical - CyFair
Albuquerque, United States
Southgate Medical Group, LLP
West Seneca, United States
Piedmont Healthcare/Research
Statesville, United States
Lillestol Research LLC
Fargo, United States

+42 more sites — see the official record for the full list.

Common questions

What is type 2 diabetes?

Type 2 diabetes is a condition where your body doesn't produce enough insulin or doesn't use insulin properly, leading to high blood sugar levels. It often develops in adulthood.

What is painful diabetic peripheral neuropathy?

This is a type of nerve damage caused by high blood sugar levels over time, leading to pain, numbness, or tingling, usually in the feet and hands.

What is a placebo?

A placebo is a 'dummy' medicine that looks just like the real medicine but contains no active ingredients. It's used in studies to compare against the real medicine.

How long will I be in the study?

For each person, the study will last for about 10 months, including regular clinic visits and follow-up.

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

No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps ensure the study results are fair and accurate.