Type 2 Diabetes MellitusPhase 3ENHANCE-INCT05466643
A Study to Investigate the Effect of DWP16001 as add-on Therapy to Drug A in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing DWP16001 0.3mg in people with Type 2 Diabetes Mellitus, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DWP16001 0.3mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Mar 2023to 30 Sep 2024
- 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
- Patients ≥19 and ≤ 80 years of age at Visit 1 (Screening) in accordance with American Diabetes Association (ADA) guidelines
- Patients who had received a stable dose of Drug A for at least 8 weeks prior to Visit 2 (Run-in vis it).
- In case of antidiabetic concomitant medications, patients who have maintained up to 2 oral antidiabetic drugs [OADs]) without changing regimen/dose/dosage at least 8 weeks prior to Visit 2 (Run-in visit).
- Patients with FPG of <270 mg/dL at Visit 1 (Screening) (FPG result at Visit 1 will use local laboratory results)
- Body Mass Index (BMI) 18.0-40.0 kg/m2.
Who cannot join
- Patients with type 1 diabetes mellitus (T1DM), congenital diabetes mellitus (DM), or secondary diabetes as follows:
- Diabetes caused by Cushing's syndrome and acromegaly.
- Patients with fasting C-peptide <0.70 ng/mL (0.23 nmol/L) are excluded if the Investigator cannot rule out T1DM based on the clinical assessment.
- Patients with a history of T1DM or a history of ketoacidosis or patients assessed by the Investigator as possibly having T1DM confirmed with a C-peptide <0.70 ng/mL (0.23 nmol/L).
- History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
- Patients receiving SGLT2 inhibitors, GLP-analogues, thiazolidinediones, or sulfonylureas (at Screening and Run in).
Show all 15Show fewer
- At Visit 1 (Screening), patients with a history of the following:
- Patients who had experienced severe hypoglycemia within 24 weeks prior to Screening or who had experienced hypoglycemia at least 3 times a week within 8 weeks prior to Screening.
- Patients with a history of diabetic ketoacidosis or coma from hyperosmolar hyperglycemic syndrome within 24 weeks.
- Patients with a history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, within 3 months prior to Screening.
- Patients with New York Heart Association (NYHA) Class III, IV congestive heart failure or arrhythmia requiring treatment. History of dose modification of a treatment for thyroid dysfunction within the past 6 weeks (If patients have been on a stable dose from before enrollment to the study, concomitant administration is allowed. Dose reduction for stable condition is allowed).
- Patients who had a surgical operation within 4 weeks (excluding minor surgeries without restriction on food and fluid intake) or who are scheduled to have a significant surgery during the study period.
- Patients with pituitary insufficiency or adrenal insufficiency.
- Patients with pulmonary embolism, severe pulmonary dysfunction, or who are susceptible to be accompanied by hypoxemia at Screening.
- Patients who are on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
About this study
Official title: A Multicenter, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 as add-on Therapy to Drug A, With or Without Antihyperglycemic Drugs, in Patients With Type 2 Diabetes Mellitus
A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group
Read the detailed description
Phase 3 study in patients with T2DM, who have inadequate glycemic control on Drug A alone or Drug A in combination with antihyperglycemic drugs.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DWP16001 0.3mg, DWP16001 Placebo
- 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.
DWP16001 0.3mgDrug
1 tablet, Orally, Once daily single dose
DWP16001 PlaceboDrug
1 tablet, Orally, Once daily single dose
| Study group | Role | What they receive |
|---|---|---|
| DWP16001 | Experimental | Not described Receives: Drug: DWP16001 0.3mg |
| Placebo | Placebo comparator | Not described Receives: Drug: DWP16001 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline HbA1c
Measured: at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start17 Mar 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
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 Type 2 Diabetes MellitusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466643
- Sponsor's protocol ID
- DW_DWP16001305
- Acronym
- ENHANCE-I
- Status last verified
- Apr 2024
- First submitted
- 12 Jul 2022
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong JH, Min KW, Lee CB, Chamnan P, Sirirak T, Sony K, Sattanon S, Kim HJ, Kim SY, Kim Y, Heo JA, Cho JM, Nah JJ, Park MH, Kim JH. Efficacy and Safety of Enavogliflozin as Add-on in Adults with Type 2 Diabetes Mellitus Inadequately Controlled with Insulin or Insulin with Other Antidiabetic Drugs. Diabetes Metab J. 2025 Dec 15. doi: 10.4093/dmj.2025.0477. Online ahead of print.
PubMed 41397686
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 as add-on Therapy to Drug A, With or Without Antihyperglycemic Drugs, in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05466643
- Acronym / sponsor ID
- ENHANCE-I / DW_DWP16001305
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 20 Jul 2022 (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.
A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group
Detailed description
Phase 3 study in patients with T2DM, who have inadequate glycemic control on Drug A alone or Drug A in combination with antihyperglycemic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWP16001 | Experimental | Drug: DWP16001 0.3mg |
| Placebo | Placebo comparator | Drug: DWP16001 Placebo |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥19 and ≤ 80 years of age at Visit 1 (Screening) in accordance with American Diabetes Association (ADA) guidelines
- Patients who had received a stable dose of Drug A for at least 8 weeks prior to Visit 2 (Run-in vis it).
- In case of antidiabetic concomitant medications, patients who have maintained up to 2 oral antidiabetic drugs [OADs]) without changing regimen/dose/dosage at least 8 weeks prior to Visit 2 (Run-in visit).
- Patients with FPG of <270 mg/dL at Visit 1 (Screening) (FPG result at Visit 1 will use local laboratory results)
- Body Mass Index (BMI) 18.0-40.0 kg/m2.
Key exclusion criteria (15 listed)
- Patients with type 1 diabetes mellitus (T1DM), congenital diabetes mellitus (DM), or secondary diabetes as follows:
- Patients receiving SGLT2 inhibitors, GLP-analogues, thiazolidinediones, or sulfonylureas (at Screening and Run in).
- At Visit 1 (Screening), patients with a history of the following:
- Patients who are on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
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 |
|---|---|---|
| DWP16001 0.3mg1 tablet, Orally, Once daily single dose | Drug | DWP16001 |
| DWP16001 Placebo1 tablet, Orally, Once daily single dose | Drug | Placebo |
Primary outcome
Changes from Baseline HbA1c
Time frame: at Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 41397686Hong JH, Min KW, Lee CB, Chamnan P, Sirirak T, Sony K, Sattanon S, Kim HJ, Kim SY, Kim Y, Heo JA, Cho JM, Nah JJ, Park MH, Kim JH. Efficacy and Safety of Enavogliflozin as Add-on in Adults with Type 2 Diabetes Mellitus Inadequately Controlled with Insulin or Insulin with Other Antidiabetic Drugs. Diabetes Metab J. 2025 Dec 15. doi: 10.4093/dmj.2025.0477. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
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 0.3mg in people with 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 15 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 8 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Younghee Kim (82-10-5768-9733, 2210285@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline HbA1c (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 NCT05466643, 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 8 Apr 2024.