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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04221399

Enrollment

Registered

2020-01-09

Start date

2020-01-31

Completion date

2020-10-31

Last updated

2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Brief 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.

Interventions

DRUGDWP16001

Tablets, Oral, Once daily, Single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum Plasma Concentration [Cmax]	on Days 1 to 4 at selected time points	—
Concentration-time curve [AUC]	on Days 1 to 4 at selected time points	—
Urine glucose (g/day)	on Days -1 to 4	Cummulative by time
Concentration of serum glucose	on Days 1 to 4 at selected time points	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026