2.3. Study population
screeningPatients, pain, active liver, neuropathies, mood disorder, depression, type 2 diabetes, T2DM
NEUROPATHIES, TYPE 2 DIABETES, TYPE 2 DIABETES MELLITUS
Patients with type 2 diabetes taking pregabalin IR 150 mg/d for at least 4 weeks before screening will be recruited. The inclusion and exclusion criteria are provided below:Inclusion criteria:
Patients capable of providing written informed consentMale or female patients between 19 and 75 years oldPatients with type 2 diabetes mellitus (T2DM) and glycosylated hemoglobin (HbA1c) ≤ 10%Patients who experience moderate to severe pain associated with DPN (visual analogue scale [VAS] score ≥ 30 at screening)Patients with stable concomitant treatment for underlying diseaseFor women of childbearing potential:
Negative serum or urine pregnancy test at the screening visitWilling to use appropriate contraception during the studyExclusion criteria:
Patients who are hypersensitive to the study drug or any of its componentsPatients who are taking anticonvulsantsPatients who are experiencing non-DPN-related painPatients with other types of neuropathies not related to DPNPatients with abnormal clinical research laboratory results at screening, defined as:
Estimated glomerular filtration rate < 30 mL/min/1.73 mMore than 3 times the upper normal limits of alanine transaminase or aspartate transaminasePatients with active liver diseasePatients with a history of alcohol or drug abusePatients determined by the investigator to be unsuitable for participation because of severe depression, uncontrolled mood disorder, or behavioral changesPregnant or lactating womenPatients participating in another clinical trial within 30 days of screeningPatients deemed ineligible for this clinical trial by the investigator