Investigate the efficacy and safety of HSK16149 capsule in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) who had an inadequate response to Pregabalin, following 4 weeks treatment in comparison to Pregabalin
Signed informed consent;
Males or females aged 18-75 years of age inclusive;
Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
HbA1c ≤ 11.0% at screening and on a stable anti-diabetic medication regimen for at least 30 days prior to screening;
Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
Skin conditions in the area affected by neurupathy that could alter sensation.
Chronic systemic diseases that may affect subjects' participation in the study.
Neutrophils < 1.5 × 10^9/L, or platelet < 90 × 10^9/L, or hemoglobin < 100 g/L;