2023-509662-38-00已完成2 期
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
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 32
- 主要终点
- Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)
研究概览
简要总结
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)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide
Test
干预措施: cagrilintide semaglutide (Drug)
Placebo + Placebo
Placebo
干预措施: Placebo + Placebo (Drug)
结局指标
主要结局
Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)
Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)
次要结局
- Time to achieve ≥50% reduction in weekly average PI-NRS Pain
- Change in Brief Pain Inventory-Short Form (BPI-SF)
- Change in Chronic Pain Sleep Inventory 3-item (CPSI 3)
- Change in Michigan Neuropathy Screening Instrument (MNSI)
- Change in systolic blood pressure
- Change in diastolic blood pressure
- Change in glycated haemoglobin (HbA1c)
- Change in Fasting Plasma Glucose (FPG)
- Relative change in body weight
- Change in waist circumference
- Participants reaching ≥30 % reduction in PI-NRS Pain (yes/no)
- Time to achieve ≥30% reduction in weekly average PI-NRS Pain
- Participants reaching ≥50 % reduction in PI-NRS Pain (yes/no)
- Ratio to baseline in: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides, Free fatty acids, Non-HDL cholesterol
- Relative change in high-sensitivity C-reactive protein (hsCRP)
- Number of treatment-emergent adverse events (TEAEs)
- Number of treatment-emergent serious adverse events (TESAEs)
- Number of severe hypoglycaemic episodes (level 3)
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter))
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (32)
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