Study of cagrilintide and semaglutide combination versus placebo in people with type 2 diabetes and painful diabetic peripheral neuropathy

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What is this study about?

This study focuses on people who have Type 2 diabetes and painful diabetic peripheral neuropathy, which is a type of nerve damage causing pain in people with diabetes. The purpose is to test if a combination medication called CagriSema (containing cagrilintide and semaglutide) works better than placebo in reducing nerve pain in these patients.

The medication being tested is given as a subcutaneous injection (an injection under the skin) once weekly. During the study, participants will receive either CagriSema or placebo. The study will measure how well the medication works by tracking changes in pain levels that participants experience.

Participants will use a special rating scale to record their pain levels throughout the study. The research will also look at other health measures such as blood sugar control, blood pressure, body weight, and various blood tests to understand how the medication affects the body. The safety of the medication will be monitored by tracking any side effects that may occur during the treatment.

1 Initial assessment

Your participation begins with measuring your body mass index (BMI), which must be 25.0 kg/m² or higher

A blood test will check your HbA1c level (a measure of blood sugar control), which should be between 6.0% and 10.5%

You will need to confirm having type 2 diabetes diagnosis for at least 180 days

2 Pain assessment period

You will need to document your nerve pain daily using an electronic diary for 2 weeks

The diary needs to be completed at least 4 out of 7 days each week

Your current pain medication should have been stable for at least 3 months

3 Treatment phase

You will receive either CagriSema (combination of cagrilintide and semaglutide) or placebo

The medication will be given as an injection under the skin once weekly

You will continue your current diabetes medications as prescribed

4 Monitoring period

Regular measurements will track your pain levels using a numerical scale

Your blood pressure, blood sugar, and body weight will be monitored

Blood tests will check cholesterol levels and other health markers

Any side effects or severe low blood sugar episodes will be recorded

5 Sleep and quality of life assessment

Your sleep quality will be evaluated using a special questionnaire

The impact of pain on your daily activities will be assessed

Changes in nerve symptoms will be monitored through specific tests

Who Can Join the Study?

  • Must be male or female aged 18 years or older
  • Must have a body mass index (BMI) of 25.0 kg/m2 or higher (BMI is a measure of body fat based on height and weight)
  • Must have been diagnosed with type 2 diabetes for at least 180 days (6 months) before screening
  • Must be on stable doses of diabetes medications for at least 90 days, which may include:
    • Oral diabetes medications (pills taken by mouth)
    • Insulin injections
  • Must have a HbA1c level between 6.0% and 10.5% (HbA1c is a blood test that measures average blood sugar levels over the past 3 months)
  • Must have painful diabetic peripheral neuropathy (nerve pain in hands or feet due to diabetes) for at least 3 months before screening
  • Must complete daily pain diary entries for at least 4 out of 7 days during the two-week screening period
  • Must be on a stable pain treatment plan (medications or other treatments) for at least 3 months before screening

Who Cannot Join the Study?

  • History of severe allergic reactions to any medications similar to those used in the study
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials or within the past 30 days
  • History of chronic alcohol abuse or drug addiction within the past 12 months
  • Major surgery within the past 3 months or planned during the study period
  • Severe kidney disease (problems with kidney function)
  • Severe liver disease (problems with liver function)
  • History of pancreatic inflammation (pancreatitis)
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • History of heart attack or stroke within the past 6 months
  • Any other medical condition that could interfere with the study treatment or make participation unsafe
  • Unable to perform self-injection of medication
  • Mental conditions that could affect ability to follow study procedures
  • History of thyroid cancer or certain other types of cancer
  • Taking medications that could interfere with the study treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Groupe Sos Sante Le Creusot France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Helse Stavanger HF Stavanger Norway
Les Hopitaux De Chartres Le Coudray France
Aalborg University Hospital Gistrup Denmark
Centre De Recherche Clinique Portes Du Sud Venissieux France
Sykehuset Innlandet HF Brumunddal Norway
Steno Diabetes Center Copenhagen Herlev Denmark
Odense University Hospital Odense Denmark
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Hopital Beaujon Clichy France
Hmhceevg Uzsxllqsurfvh Di Lw Perxndau Madrid Spain
Hhusatao Uxjdrrxbjpmtl Mawmbsd Dx Veqyexkiwp Santander Spain
Hndsa Bqwuou Hc Bergen Norway
Haezzrwl Usgaqjsjmievi Hiknsnsk Turgf y Poacwe Ijwzsimn Chttba dxgefllsxrvbnciav (oqck Badalona Spain
Hlmvtvus Vqzb dsofsmlg Barcelona Spain
Hwgmkbpv Uvdbgpyljdmjv di A Ckhoiy A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
29.01.2025
France France
Not recruiting
29.01.2025
Norway Norway
Not recruiting
29.01.2025
Spain Spain
Not recruiting
29.01.2025

Trial locations

Investigated drugs:

Cagrilintide is a medication being studied for treating people with type 2 diabetes who also experience painful diabetic nerve damage. It is designed to be given as an injection under the skin once per week.

Semaglutide is a medication used to treat type 2 diabetes. It helps control blood sugar levels and is given as an injection under the skin once per week. It belongs to a class of medications called GLP-1 receptor agonists, which help the body produce more insulin when blood sugar levels are high.

CagriSema is a combination therapy that contains both cagrilintide and semaglutide in a single treatment. It is being studied as a weekly injection for people who have type 2 diabetes and painful diabetic nerve damage (diabetic peripheral neuropathy).

Type 2 diabetes – A chronic metabolic disorder where the body becomes resistant to insulin or doesn’t produce enough insulin to maintain normal blood sugar levels. The condition develops gradually, usually in adults, causing high blood sugar levels that can damage various body systems over time. The body either resists the effects of insulin or doesn’t produce sufficient insulin to maintain normal glucose levels.

Diabetic peripheral neuropathy – A nerve disorder that occurs as a complication of diabetes, causing damage to the nerves in the extremities, particularly the feet and legs. It typically begins with numbness, tingling, or burning sensations in the affected areas and can progress to cause varying degrees of pain. The condition develops gradually and can affect both sensory and motor nerves in the peripheral nervous system.

Trial ID:
2023-509662-38-00
Protocol code:
NN9388-7864
Trial Phase:
Therapeutic exploratory (Phase II)

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