Type 2 Diabetes Patients With Renal Impairment

• Status: Not yet recruiting
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Criteria

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