T2DM (Type 2 Diabetes Mellitus)Phase 3ENHANCE-MEXTNCT05376969
Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin
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.
Trial summary
A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin 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?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 May 2021to 16 May 2022
- 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
- Participated in the prior phase 3 study (Protocol No: DW_DWP16001302) for meeting the inclusion criteria and completed the study
- Voluntarily decided to participate in the extension study and provided a written consent on the consent form
Who cannot join
- Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator
- Subjects with the following diseases or signs:
- Diabetic ketoacidosis
- Moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m2
- Females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study
- Subjects must agree to one of the following appropriate contraceptive methods for subjects or their partners:
Show all 9Show fewer
- ① Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
- ② A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or
- ③ Use of male condom combined with either cervical cap or diaphragm Determined to be ineligible for the study by the investigator, besides the above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin
- 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 Tablets
| Study group | Role | What they receive |
|---|---|---|
| DWP16001 Amg | Experimental | DWP16001 Amg, Tablets, Orally, Once daily Receives: Drug: DWP16001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria
Measured: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Secondary outcomes (3)
Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
- Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001302)
Measured: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
- Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001302)
Measured: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
- Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001302)
Measured: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start25 May 2021
- Primary completion16 May 2022
- Study completion16 May 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
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
- NCT05376969
- Sponsor's protocol ID
- DW_DWP16001302_Ext
- Acronym
- ENHANCE-MEXT
- Status last verified
- Oct 2022
- First submitted
- 9 Jan 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sohn TS, Han KA, Kim Y, Lee BW, Chon S, Jeong IK, Hong EG, Son JW, Na J, Cho JM, In Cho S, Huh W, Yoon KH. A 52-week efficacy and safety study of enavogliflozin versus dapagliflozin as an add-on to metformin in patients with type 2 diabetes mellitus: ENHANCE-M extension study. Diabetes Obes Metab. 2024 Jun;26(6):2248-2256. doi: 10.1111/dom.15537. Epub 2024 Mar 8.
PubMed 38456558
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, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
- ClinicalTrials.gov ID
- NCT05376969
- Acronym / sponsor ID
- ENHANCE-MEXT / DW_DWP16001302_Ext
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 17 May 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 Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DWP16001 Amg | Experimental | Drug: DWP16001DWP16001 Amg, 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 (2 listed)
- Participated in the prior phase 3 study (Protocol No: DW_DWP16001302) for meeting the inclusion criteria and completed the study
- Voluntarily decided to participate in the extension study and provided a written consent on the consent form
Key exclusion criteria (9 listed)
- Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator
- Subjects with the following diseases or signs:
- Females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study
- Subjects must agree to one of the following appropriate contraceptive methods for subjects or their partners:
- ① Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
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 Tablets | Drug | DWP16001 Amg |
Primary outcome
Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria
3 secondary outcomes
Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
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 38456558Sohn TS, Han KA, Kim Y, Lee BW, Chon S, Jeong IK, Hong EG, Son JW, Na J, Cho JM, In Cho S, Huh W, Yoon KH. A 52-week efficacy and safety study of enavogliflozin versus dapagliflozin as an add-on to metformin in patients with type 2 diabetes mellitus: ENHANCE-M extension study. Diabetes Obes Metab. 2024 Jun;26(6):2248-2256. doi: 10.1111/dom.15537. Epub 2024 Mar 8.
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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.
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 2 inclusion and 9 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. 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?
Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP (time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP). 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 NCT05376969, 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.