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Type2 DiabetesPhase 1NCT04221399

Type 2 Diabetes Patients With Renal Impairment

A Phase 1 study testing DWP16001 in people with Type2 Diabetes, run by Daewoong Pharmaceutical Co. LTD..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type2 Diabetes
What is being tested?
DWP16001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
Jan 2020to Oct 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Conditions
Type2 Diabetes
Being tested
DWP16001

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DWP16001Drug

    Tablets, Oral, Once daily, Single dose

  • DWP16001Drug

    Tablets, Oral, Once daily, Multiple dose

Study groups in NCT04221399
Study groupRoleWhat they receive
DWP16001 Single doseExperimentalSingle dose
Receives: Drug: DWP16001
DWP16001 Multiple doseExperimentalUp to 7 days
Receives: Drug: DWP16001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma Concentration [Cmax]

    Measured: on Days 1 to 4 at selected time points

  2. Concentration-time curve [AUC]

    Measured: on Days 1 to 4 at selected time points

  3. Urine glucose (g/day)

    Cummulative by time

    Measured: on Days -1 to 4

  4. Concentration of serum glucose

    Measured: on Days 1 to 4 at selected time points

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2020
  2. Study startJan 2020 (estimated)
  3. Primary completionAug 2020 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04221399
Sponsor's protocol ID
DW_DWP16001103
Status last verified
Jan 2020
First submitted
17 Dec 2019
Last updated
9 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jeong SI, Ban MS, Hwang JG, Park MK, Lim S, Kim S, Kwon SK, Kim Y, Cho JM, Na JJ, Huh W, Chung JY. The effect of renal function on the pharmacokinetics and pharmacodynamics of enavogliflozin, a potent and selective sodium-glucose cotransporter-2 inhibitor, in type 2 diabetes. Diabetes Obes Metab. 2024 Jul;26(7):2588-2597. doi: 10.1111/dom.15573. Epub 2024 Apr 15.

    PubMed 38618974

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DWP16001 in people with Type2 Diabetes, run by Daewoong Pharmaceutical Co. LTD..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration [Cmax] (time frame: on Days 1 to 4 at selected time points). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04221399, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.

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