A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
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Male or female.
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Age 18 years or above at the time of signing the informed consent.
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Body mass index (BMI) ≥25.0 kilogram per square meter (kg/m^2) at screening.
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Diagnosis of type 2 diabetes (T2D) ≥180 days before screening.
- Stable daily and/or weekly dose(s) ≥90 days before screening of any of the following anti-diabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose, as judged by the investigator:
- Treatment with 1-3 marketed oral anti-diabetic 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 insulin (including neutral protamine Hagedorn (NPH) insulin) according to local guidelines.
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HbA1c ≤10.5 % (91 millimole per mole [mmol/mol]) and ≥6.5 % (48 mmol/mol), as determined by central laboratory at screening.
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Diagnosis of painful diabetic peripheral neuropathy (pDPN) based on 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
- Michigan Neuropathy Screening Instrument (MNSI) q≥4 or e≥2.5 at screening. AND
- Douleur Neuropathique en 4 Questions (DN4) (Question 1 and 2) ≥4 at screening.
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The weekly average in Pain Intensity-Numerical Rating Scale (PI-NRS) score must meet the following criteria in both weeks during the screening period (day -15 to -8 and day -7 to -1):
- Completion of daily PI-NRS reporting in the eDiary for a minimum of 4 out of 7 days each week. AND
- The weekly average PI-NRS score must be ≥4.0. AND
- The standard deviation (SD) of the weekly average PI-NRS score must be ≤2.0.
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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).
Key Exclusion Criteria:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, 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.
- 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 corticosteroids).
- Planned initiation or change in anti-depressant, anti-psychotic or anti-epileptic 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 and 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.
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
134 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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