T2DM (Type 2 Diabetes Mellitus)Phase 3NCT06141980
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing DWP16001 0.3 mg in people with T2DM (Type 2 Diabetes Mellitus), run by Daewoong Pharmaceutical Co. LTD..
Trial summary
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- DWP16001 0.3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Sep 2025
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with T2DM age 19 ~ under 80 years
- Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1)
- Subjects who have FPG <270 mg/dl screening visit(V1-1)
- Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit)
- 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
- Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
- Diabetic ketoacidosis, diabetic coma or precoma within the past year
- Urinary tract infections or genital infections within
- Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
- eGFR < 45 mL/min/1.73 m2
- Severe heart failure (NYHA class III/IV
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, phase3, Open-label Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Gemigliptin
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period.
At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.
The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.
Read the detailed description
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs.
At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.
The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- DWP16001 0.3 mg
- 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 0.3 mgDrug
DWP16001 0.3mg, Tablets, Orally, Once daily
| Study group | Role | What they receive |
|---|---|---|
| Study group (DWP16001 0.3 mg) | Experimental | DWP16001 0.3mg, Tablets, Orally, Once daily Receives: Drug: DWP16001 0.3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcomes_Adverse events occurred during clinical trials
Safety outcomes_Adverse events occurred during clinical trials
Measured: from baseline up to 52 weeks
Safety outcomes_ Change of blood pressure
Safety outcomes_ Change of blood pressure
Measured: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Safety outcomes_ Change of heartbeat
Safety outcomes_ Change of heartbeat
Measured: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Safety outcomes_ Change of body temperature
Safety outcomes_ Change of body temperature
Measured: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Efficacy outcome_Change of HbA1c
Efficacy outcome_Change of HbA1c
Measured: from Baseline at Week 8, 16, 24, 38, and 52 after administration of the IP
Efficacy outcome_Change of FPG
Efficacy outcome_Change of FPG
Measured: from baseline at Week 8, 16, 24, 38, and 52 after administration of the IP
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%
Measured: at Weeks 8, 16, 24, 38 and 52 after administration of the IP
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 7.0 %
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%
Measured: at Weeks 8, 16, 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 posted21 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
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.
- 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
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soo Lim, MD, PH.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141980
- Sponsor's protocol ID
- DW_DWP16001308
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 21 Nov 2023
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, phase3, Open-label Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Gemigliptin
- ClinicalTrials.gov ID
- NCT06141980
- Acronym / sponsor ID
- DW_DWP16001308
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Nov 2023 (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 subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period.
At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.
The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.
Detailed description
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs.
At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.
The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group (DWP16001 0.3 mg) | Experimental | Drug: DWP16001 0.3 mgDWP16001 0.3mg, Tablets, Orally, Once daily |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with T2DM age 19 ~ under 80 years
- Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1)
- Subjects who have FPG <270 mg/dl screening visit(V1-1)
- Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit)
- 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)
- Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
- Diabetic ketoacidosis, diabetic coma or precoma within the past year
- Urinary tract infections or genital infections within
- Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
- eGFR < 45 mL/min/1.73 m2
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 0.3 mgDWP16001 0.3mg, Tablets, Orally, Once daily | Drug | Study group (DWP16001 0.3 mg) |
Primary outcome
Safety outcomes_Adverse events occurred during clinical trials
Time frame: from baseline up to 52 weeks
Safety outcomes_Adverse events occurred during clinical trials
Safety outcomes_ Change of blood pressure
Time frame: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Safety outcomes_ Change of blood pressure
Safety outcomes_ Change of heartbeat
Time frame: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Safety outcomes_ Change of heartbeat
Safety outcomes_ Change of body temperature
Time frame: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
Safety outcomes_ Change of body temperature
Efficacy outcome_Change of HbA1c
Time frame: from Baseline at Week 8, 16, 24, 38, and 52 after administration of the IP
Efficacy outcome_Change of HbA1c
Efficacy outcome_Change of FPG
Time frame: from baseline at Week 8, 16, 24, 38, and 52 after administration of the IP
Efficacy outcome_Change of FPG
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%
Time frame: at Weeks 8, 16, 24, 38 and 52 after administration of the IP
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 7.0 %
Time frame: at Weeks 8, 16, 24, 38 and 52 after administration of the IP
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for T2DM (Type 2 Diabetes Mellitus)
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
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.
Soo Lim, MD, PH.D principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWP16001 0.3 mg in people with T2DM (Type 2 Diabetes Mellitus), 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 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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 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 Jayoung Shon (+82-10-9811-6679, jyshon@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcomes_Adverse events occurred during clinical trials (time frame: from baseline up to 52 weeks). The study lists 8 primary outcomes in all. 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 21 Nov 2023.