T2DM (Type 2 Diabetes Mellitus)Phase 3NCT04654390
The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus
A Phase 3 study testing DWP16001 Amg in people with T2DM (Type 2 Diabetes Mellitus), run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the efficacy and safety of DWP16001 compared to active drug 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 Amg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Dec 2020to 17 Dec 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 ≤ 11% at Screening
- Subjects with BMI of 20-45 kg/m2
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
The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea
Bucheon-si
About this study
Official title: A Multi-center, Randomized, Double-Blind, Active-controlled, Phase3, 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 active drug in the treatment of type 2 diabetes mellitus.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- DWP16001 Amg
- 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 AmgDrug
Tablets, Orally, Once daily
| Study group | Role | What they receive |
|---|---|---|
| DWP16001 Amg, Dapagiflozin Bmg placebo | Experimental | Tablets, Orally, Once daily Receives: Drug: DWP16001 Amg |
| DWP16001 Amg placebo, Dapagliflozin Bmg | Active comparator | Tablets, Orally, Once daily Receives: Drug: DWP16001 Amg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP
HbA1c level at Week 24 after administration of the IP
Measured: at Week 24
Secondary outcomes (3)
Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP
HbA1c level at Weeks 6, 12, and 18 after administration of the IP
Measured: at weeks 6, 12, and 18
Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
Measured: at weeks 6, 12, 18, and 24
Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP
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.
- First posted4 Dec 2020
- Study start30 Dec 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sungrae KIm, MD, PhD, Study director, The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654390
- Sponsor's protocol ID
- DW_DWP16001303
- Status last verified
- Mar 2022
- First submitted
- 19 Nov 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Active-controlled, Phase3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04654390
- Acronym / sponsor ID
- DW_DWP16001303
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 4 Dec 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 active drug 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, Dapagiflozin Bmg placebo | Experimental | Drug: DWP16001 AmgTablets, Orally, Once daily |
| DWP16001 Amg placebo, Dapagliflozin Bmg | Active comparator | Drug: DWP16001 AmgTablets, 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 (3 listed)
- Adults aged 19 to 80 years
- Subjects with 7% ≤ HbA1c ≤ 11% at Screening
- Subjects with BMI of 20-45 kg/m2
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 |
|---|---|---|
| DWP16001 AmgTablets, Orally, Once daily | Drug | DWP16001 Amg placebo, Dapagliflozin Bmg, DWP16001 Amg, Dapagiflozin Bmg placebo |
Primary outcome
Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP
Time frame: at Week 24
HbA1c level at Week 24 after administration of the IP
3 secondary outcomes
Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP
Time frame: at weeks 6, 12, and 18
Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
Time frame: at weeks 6, 12, 18, and 24
Proportions of subjects who achieved 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 1 Apr 2022.
- 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.
Sungrae KIm, MD, PhD study director
The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea
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 Amg 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 3 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 1 Apr 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?
Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation 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?
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 1 Apr 2022.