Type 2 Diabetes Patients With Renal Impairment

Daewoong Pharmaceutical

Status and phase

Unknown

Phase 1

Conditions

Type2 Diabetes

Treatments

Drug: DWP16001

Study type

Interventional

Funder types

Industry

Identifiers

NCT04221399

DW_DWP16001103

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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