Type 2 Diabetes Patients With Renal Impairment

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: DWP16001
* Drug: DWP16001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP16001 Single dose<br>Single dose | Drug: DWP16001<br>* Tablets, Oral, Once daily, Single dose<br>|
| Experimental: DWP16001 Multiple dose<br>Up to 7 days | Drug: DWP16001<br>* Tablets, Oral, Once daily, Multiple dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Cummulative by time | on Days -1 to 4 | 
| Concentration of serum glucose |  | on Days 1 to 4 at selected time points |