Type 2 Diabetes Patients With Renal Impairment

A Single- and Multiple-Dose Clinical Study to Evaluate Pharmacokinetics and Pharmacodynamics of DWP16001 Following Oral Dose in Type 2 Diabetes Patients With Renal Impairment

The purpose of the study is to evaluate the effect of kidney function on pharmacokinetics and pharmacodynamics of DWP16001 following single and multiple oral doses in type 2 diabetes patients with normal kidney function and renal impairment.

Inclusion Criteria:

• Aged ≥ 19 years at the time of screening test
• Body weight of ≥ 50.0 kg to ≤ 90.0 with a body mass index (BMI) of ≥ 20.0 to ≤ 45.0
• Have been diagnosed with type 2 diabetes

Exclusion Criteria:

• Have clinically uncontrolled or unstable hepatic, neurological, immune system, respiratory, hemato-oncology, cardiovascular, or psychiatric disorder (subject with chronic disease such as hypertension, diabetes, and hyperlipidemia that is well controlled or stable is eligible to participate in the study based on investigator's judgement)

• History of gastrointestinal diseases, dialysis, kidney transplantation, HIV, hepatitis B or C, acute or chronic infection, recent diabetic ketoacidosis, or gastrointestinal surgery that may affect the absorption of the study drug

• Received SGLT2 inhibitors or drugs of thiazolidinedione class within 6 weeks of scheduled IP administration day

• Clinical laboratory test values are outside the accepted normal range at screening

  • AST (SGOT), ALT (SGPT) > 2 x the upper limit of normal
  • Repeatedly confirmed QTc interval > 450 ms

• Sitting systolic blood pressure < 80 mmHg or > 180 mmHg or sitting diastolic blood pressure < 60 mmHg or > 110 mmHg after resting for more than 3 minutes

• Other exclusive inclusion criteria, as defined in the protocol