Type 2 Diabetes Patients With Renal Impairment

January 6, 2020 updated by: Daewoong Pharmaceutical Co. LTD.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DWP16001 Single dose
Single dose
Drug: DWP16001
Tablets, Oral, Once daily, Single dose
Drug: DWP16001
Tablets, Oral, Once daily, Multiple dose
Experimental: DWP16001 Multiple dose
Up to 7 days
Drug: DWP16001
Tablets, Oral, Once daily, Single dose
Drug: DWP16001
Tablets, Oral, Once daily, Multiple dose

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWP16001103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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