Type 2 Diabetes Patients With Renal Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-10-31

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.

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Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DWP16001 Single dose

Single dose

Group Type EXPERIMENTAL

DWP16001

Intervention Type DRUG

Tablets, Oral, Once daily, Single dose

DWP16001 Multiple dose

Up to 7 days

Group Type EXPERIMENTAL

DWP16001

Intervention Type DRUG

Tablets, Oral, Once daily, Multiple dose

Interventions

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DWP16001

Tablets, Oral, Once daily, Single dose

Intervention Type DRUG

DWP16001

Tablets, Oral, Once daily, Multiple dose

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No