Diabetic Peripheral Neuropathic Pain
Conditions
Interventions
HL-1186 Group 1:HL-1186 for 12 weeks
HL-1186 Group 2:HL-1186 for 12 weeks
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Aged between 18 and 75 years old (inclusive), regardless of gender. (2)With Type 1 or Type 2 diabetes mellitus, with a diagnosis of DPNP for at least 6 months. (3)Screening period: ADPS ranging from 4 to 9 points, and Visual Analog Scale (VAS) scores of 40mm - 90mm in two different days. (4)The hypoglycemic regimen has been stable for at least 4 weeks before enrollment, and the glycated hemoglobin (HbA1c) during the screening period is<=9%. (5)Participants fully understand the purpose, characteristics, methods of the trial and possible adverse events, voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects were excluded from the study if they met any of the following criteria: (1) patients with any pain other than DPNP, or with other diseases that researchers think may affect the evaluation of DPNP, such as cerebrovascular diseases, chronic kidney diseases, cervical and lumbar diseases, osteoarticular or tendinopathy, thyroid diseases, skin diseases that affect sensation, etc. (2) patients who may be allergic to HL-1186, HL-1186 placebo, acetaminophen tablets and their excipients, have allergic constitution, or have a history of allergy to more than 3 substances; (3) patients who had used drugs that may damage the nerve (such as tumor chemotherapy drugs) after the diagnosis of diabetic peripheral neuropathy; (4) use of any prohibited drug within 2 weeks before screening (or within 5 half-lives of the last use of the prohibited drug at screening, whichever was longer); (5) Acute complications of diabetes, such as diabetic ketoacidosis, hyperglycemia and hyperosmolar state, lactic acidosis, acute attack of severe hypoglycemia, or amputation of lower limbs except toes at the time of screening within 6 months before screening; (6) Clinically significant (e.g., QTcF>=450ms) abnormal 12-lead electrocardiogram during the screening period, or with severe cardiopulmonary diseases that were not considered suitable for inclusion by the investigator, such as: Unstable angina pectoris, myocardial infarction, severe arrhythmia requiring treatment (such as ? degree atrioventricular block), NYHA functional class >=?, poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), recurrent asthma attacks, etc. (7) Comorbid neuropsychiatric diseases, such as depression, anxiety, epilepsy, recurrent dizziness, memory and cognitive impairment, and previous suicidal behavior or suicidal tendency, which may affect the evaluation of DPNP or scale evaluation; (8) patients with a history of cancer within 2 years before screening (except those with basal cell carcinoma, squamous cell carcinoma, or stage 0 cervical carcinoma in situ and confirmed cured by investigators); (9) clinically significant and unstable diseases of the nervous system, psychiatric system, ophthalmological system, hepatobiliary system, respiratory system, hematological system or cardiovascular system within 1 year before screening, which would endanger the safety of subjects, limit the completion of study procedures or affect the purpose of the study; (10) At screening, clinical laboratory values exceed the following limits: White blood cell count 2.5 × ULN; Total bilirubin (TBil) >1.5 × ULN, creatine kinase (CK) >2.0 × ULN, estimated glomerular filtration rate (eGFR) ULN, or hepatitis C virus antibody positive and hepatitis C virus RNA>ULN; (12) those with a history of alcohol or drug abuse within 2 years before screening; (13) pregnant, lactating (within 1 year after delivery) women, or women with a positive pregnancy test; (14) subjects of childbearing potential had plans of fertility/sperm cryopreservation or sperm/egg donation within 6 months after signing the informed consent, or did not agree to tak
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric pain rating scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactGuo Xiaohui, Gao Ying
Peking University First Hospital
Outcome results
None listed