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A research study to investigate the effects of CagriSema compared to placebo in people with type 2 diabetes and painful diabetic peripheral neuropathy
EU CTIS ID: 2023-509662-38-00
What this study is testing
To demonstrate the superiority of Semaglutide + Cagrilintide s.c. 0.0 mg/0.0 mg once weekly versus placebo with respect to reduction of neuropathic pain in participants with type 2 diabetes (T2D) and painful diabetic peripheral neuropathy (pDPN)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female.
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) ≥25.0 kg/m2 at screening.
- Diagnosis of type 2 diabetes (T2D) ≥180 days before screening. For participants on anti-diabetic drugs: Stable daily and/or weekly dose(s) ≥90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose, as judged by the investigator: Treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i), thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local guidelines. Treatment with basal or basal-bolus insulin (including premixed insulin formulations) according to local guidelines.
- HbA1c ≤10.5 % (91 mmol/mol) and ≥6.0 % (42 mmol/mol), as determined by central laboratory at screening.
- Diagnosis of painful diabetic peripheral neuropathy (pDPN) at screening as well as the following criteria: Participant with self-reported pain consistent with pDPN for a minimum of 3 months before screening, as judged by the investigator. AND CCI at screening. AND CCI at screening.
You likely can't join if
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Any other painful medical condition(s) where the pain is significantly more severe than the diabetic peripheral neuropathy pain, as judged by the investigator (participants will not be excluded if the pain is transient in nature).
- History of suicidal attempt within 5 years before screening.
- Suicidal behaviour within 1 month before screening.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73 m2 as determined by central laboratory at screening.
- Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
See the full eligibility criteria
Who can join
- Male or female.
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) ≥25.0 kg/m2 at screening.
- Diagnosis of type 2 diabetes (T2D) ≥180 days before screening. For participants on anti-diabetic drugs: Stable daily and/or weekly dose(s) ≥90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose, as judged by the investigator: Treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i), thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local guidelines. Treatment with basal or basal-bolus insulin (including premixed insulin formulations) according to local guidelines.
- HbA1c ≤10.5 % (91 mmol/mol) and ≥6.0 % (42 mmol/mol), as determined by central laboratory at screening.
- Diagnosis of painful diabetic peripheral neuropathy (pDPN) at screening as well as the following criteria: Participant with self-reported pain consistent with pDPN for a minimum of 3 months before screening, as judged by the investigator. AND CCI at screening. AND CCI at screening.
- The weekly CCI must meet the following criteria in both weeks during the screening period (day -14 to -8 and day -7 to -1): Completion of daily CCI reporting in the eDiary for a minimum of 4 out of 7 days each week. AND The weekly CCI. AND The CCI.
- Stable pharmacological and non-pharmacological treatment of pain for a minimum of 3 months before screening, in the opinion of the investigator. The treatment regimen should adhere to local guidelines (if available).
What rules you out
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Any other painful medical condition(s) where the pain is significantly more severe than the diabetic peripheral neuropathy pain, as judged by the investigator (participants will not be excluded if the pain is transient in nature).
- History of suicidal attempt within 5 years before screening.
- Suicidal behaviour within 1 month before screening.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73 m2 as determined by central laboratory at screening.
- Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Use of any glucagon-like peptide-1 receptor agonist (GLP1 RA), including medication with GLP1 RA activity (DPP-4), or amylin analogue within 60 days before screening.
- Significant use of opioids, cannabinoids or benzodiazepines within 30 days before screening, in the opinion of the investigator. Significant use is defined as use that renders it unlikely that the participant is able to comply with protocol requirements for discouraged medications.
- Anticipated initiation or clinically relevant change in concomitant medications (for more than 14 consecutive days during the study) known to affect weight or glucose metabolism (e.g., orlistat, thyroid hormones or oral systemic corticosteroids).
- Planned initiation or change in antidepressant, antipsychotic or antiepileptic medication. If participants are already taking such medication, they should have stable and optimised treatment for at least 8 weeks before screening.
- Presence or history of epilepsy.
- Presence or history of fibromyalgia.
- Presence of non-diabetic neuropathies, in the opinion of the investigator.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination and OCT assessment performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.