Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN

This 24-week, multicentre, randomised, double-blind, placebo-controlled phase III study is to assess the efficacy and safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese patients with paresthesia caused by DPN.The trial included a 2-week screening period, a 1-week placebo run-in period, a 24-week randomized treatment period, and a 2-week follow-up period.

Inclusion criteria

• Age ≥ 18 and ≤ 70 years, Male and female patients;
• Type 1 or 2 diabetes mellitus on hypoglycemic therapy for 3 months or more, and clinical diagnosis of DPN;
• HbA1c < 9.0%;
• Toronto Clinical Neuropathy Score ≥ 6 at screening and baseline.

Exclusion criteria

• Peripheral neuropathy caused by other diseases;
• History of acute complications of diabetes within the past 6 months, such as diabetic ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome or lactic acidosis, etc.;
• Severe peripheral arterial disease; severe cardiopulmonary disease; or have a history of myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months before enrollment; or uncontrolled asthma or shortness of breath 2 months before enrollment; World Health Organization (WHO) cardiac function class III-IV; systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at screening;
• Any infection at the screening visit that is not suitable for study participation;
• Aspartate Transaminase (AST) or Alanine Transaminase (ALT) or total bilirubin or creatinine > 2 times Upper Limit of Normal (ULN);
• Known allergy to L-carnitine ingredients;
• Severe systemic or psychiatric illness, history of epilepsy;
• History of malignancy or antitumor therapy;
• Severe bleeding disorder;
• Clinically significant abnormalities in thyroid function tests;
• Triglyceride >5.6 mmol/L;
• Change of 2 points or more in the same item in mTCNS;
• Nursing or pregnant women.