CClinicalTrials.gg
Status unknownNCT04221399Updated Jan 9, 2020

Type 2 Diabetes Patients With Renal Impairment

A Phase 1 interventional study of DWP16001 and DWP16001 in Type2 Diabetes, sponsored by Daewoong Pharmaceutical Co. LTD.. Status unknown. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 35 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    DWP16001 Single dose

    Single dose

    Drug: DWP16001

  • Experimental
    DWP16001 Multiple dose

    Up to 7 days

    Drug: DWP16001

Interventions

  • DrugDWP16001

    Tablets, Oral, Once daily, Single dose

  • DrugDWP16001

    Tablets, Oral, Once daily, Multiple dose

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration [Cmax]

    Time frame: on Days 1 to 4 at selected time points

  2. Concentration-time curve [AUC]

    Time frame: on Days 1 to 4 at selected time points

  3. Urine glucose (g/day)

    Cummulative by time

    Time frame: on Days -1 to 4

  4. Concentration of serum glucose

    Time frame: on Days 1 to 4 at selected time points

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04221399
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jan 9, 2020
Start date
Jan 2020 (estimated)
Primary completion
Aug 2020 (estimated)
Completion
Oct 2020 (estimated)
Last update
Jan 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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