7864: Study to investigate the effects of CagriSema compared to placebo in people with T2D and pDPN
Research type
Research Study
Full title
Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) once weekly versus placebo in participants with type 2 diabetes and painful diabetic peripheral neuropathy
IRAS ID
1010607
Contact name
Sanaz Gabery
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2023-509662-38
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
People with type 2 diabetes have too high blood sugar. Over time, this can lead to damage to nerves in the body, which can cause pain and disturbed sensation in the legs and feet. This type of nerve pain related to diabetes is also called 'painful diabetic peripheral neuropathy'. The study medicine CagriSema combines 2 medicines named cagrilintide and semaglutide. CagriSema will be compared to a "dummy" medicine, called a placebo, that has no effect on the body. This study will look at the effects of CagriSema compared to placebo in people with both type 2 diabetes and painful diabetic peripheral neuropathy.
The study will last for about 38 weeks, participants will take the study medicine for 32 weeks.
Participants must be on a stable dose of treatment for both their diabetes and pain management for at least 3 months before joining the study. Participants must not take any narcotics or cannabis for 1 month before joining the study. Participants with conditions such as epilepsy, chronic pain and tiredness (fibromyalgia), nerve damage (neuropathies) not related to diabetes, or any other painful condition where the pain is worse than the painful diabetic peripheral neuropathy cannot take part in the study. Persons with certain severe diseases of the kidneys, eyes, heart, or pancreas cannot take part in the study. Women who are pregnant, breastfeeding, or planning to become pregnant cannot participate in the study. Women who are able to become pregnant must use a highly effective method of birth control during the study.
Height body weight and waist circumference will be measured; blood samples will be taken to analyse blood sugar and other parameters. Eyes, heart, and body in general will also be checked. Participants will use a Study App to record how much nerve pain they experience and any extra pain medication they take during the study. Participants will have to answer questionnaires about pain, sleep, and daily activities and record low blood sugar episodes.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0616
Date of REC Opinion
18 Nov 2024
REC opinion
Further Information Favourable Opinion