T2DM (Type 2 Diabetes Mellitus)Phase 3NCT04632862

The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.

A Phase 3 study testing DWP16001 in people with T2DM (Type 2 Diabetes Mellitus), run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus. Read more about this study

Who is it for?: Ages 19 to 80 years
Conditions the study is for: T2DM (Type 2 Diabetes Mellitus)
What is being tested?: DWP16001
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 1 siteSouth Korea
Study dates: 11 Nov 2020to 25 Nov 2021
Phase: Phase 3
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged 19 to 80 years
Subjects with 7% ≤ HbA1c ≤ 10% who have been diagnosed with T2DM at least 8 weeks
Subjects with BMI of 20-45 kg/m2
Subjects who have been on a stable diet and exercise program for at least 8 weeks
Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Who cannot join

Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
eGFR < 60 mL/min/1.73 m2
Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Daewoong pharmatceutical
Seoul

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.

Conditions: T2DM (Type 2 Diabetes Mellitus)
Being tested: DWP16001
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

DWP16001Drug
DWP16001 A mg

Study groups in NCT04632862
Study group	Role	What they receive
DWP16001 Amg	Experimental	DWP16001 Amg, Tablets, Orally, Once daily Receives: Drug: DWP16001
DWP16001 Amg Placebo	Placebo comparator	DWP16001 Amg Placebo, Tablets, Orally, Once daily Receives: Drug: DWP16001

What is being measured

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

HbA1c level at Week 24 after administration of the IP
1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP
Measured: at Week 24

Secondary outcomes (3)

HbA1c level at Weeks 6, 12, and 18 after administration of the IP
1.Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP
Measured: at weeks 6, 12, and 18
FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
2.Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
Measured: at weeks 6, 12, 18, and 24
HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP
3.Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP
Measured: at weeks 6, 12, 18, and 24

Timeline

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

11 Nov 202025 Nov 2021

First posted17 Nov 2020
Study start11 Nov 2020
Primary completion25 Nov 2021
Study completion25 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04632862
Sponsor's protocol ID: DW_DWP16001301
Status last verified: Oct 2022
First submitted: 12 Nov 2020
Last updated: 25 Oct 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kwak SH, Han KA, Kim ES, Choi SH, Won JC, Yu JM, Oh S, Yoo HJ, Kim CH, Kim KS, Chun S, Kim YH, Cho SA, Kim DH, Park KS. Long-term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52-week extension of a Phase 3 randomized controlled trial. Diabetes Obes Metab. 2024 Oct;26(10):4203-4212. doi: 10.1111/dom.15738. Epub 2024 Jul 26.
PubMed 39054871

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All T2DM (Type 2 Diabetes Mellitus) trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT04632862
Acronym / sponsor ID: DW_DWP16001301
Conditions: T2DM (Type 2 Diabetes Mellitus)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
Study start: 11 Nov 2020 (actual)
Primary completion: 25 Nov 2021 (actual)
Study completion: 25 Nov 2021 (actual)
First posted: 17 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DWP16001 Amg	Experimental	Drug: DWP16001DWP16001 Amg, Tablets, Orally, Once daily
DWP16001 Amg Placebo	Placebo comparator	Drug: DWP16001DWP16001 Amg Placebo, Tablets, Orally, Once daily

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults aged 19 to 80 years
Subjects with 7% ≤ HbA1c ≤ 10% who have been diagnosed with T2DM at least 8 weeks
Subjects with BMI of 20-45 kg/m2
Subjects who have been on a stable diet and exercise program for at least 8 weeks
Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Key exclusion criteria (6 listed)

Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
eGFR < 60 mL/min/1.73 m2
Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DWP16001DWP16001 A mg	Drug	DWP16001 Amg, DWP16001 Amg Placebo

Primary outcome

HbA1c level at Week 24 after administration of the IP
Time frame: at Week 24
1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP

3 secondary outcomes

HbA1c level at Weeks 6, 12, and 18 after administration of the IP
Time frame: at weeks 6, 12, and 18
FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
Time frame: at weeks 6, 12, 18, and 24
HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP
Time frame: at weeks 6, 12, 18, and 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
Derived from this study: PubMed 39054871Kwak SH, Han KA, Kim ES, Choi SH, Won JC, Yu JM, Oh S, Yoo HJ, Kim CH, Kim KS, Chun S, Kim YH, Cho SA, Kim DH, Park KS. Long-term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52-week extension of a Phase 3 randomized controlled trial. Diabetes Obes Metab. 2024 Oct;26(10):4203-4212. doi: 10.1111/dom.15738. Epub 2024 Jul 26.

Related trials for T2DM (Type 2 Diabetes Mellitus)

Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
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RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
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Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DWP16001 in people with T2DM (Type 2 Diabetes Mellitus), run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HbA1c level at Week 24 after administration of the IP (time frame: at Week 24). 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 NCT04632862, 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 25 Oct 2022.