Diabetes MellitusPhase 3NCT05505994
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
A Phase 3 study testing DWP16001 and Dapagliflozin in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Daewoong Pharmaceutical Co. LTD. at 1 site in China.
Trial summary
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
- What is being tested?
- DWP16001 and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2022to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with T2DM aged 18 to 80 years
- Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
- Subjects with BMI of 20-45 kg/m2
- 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 < 60 mL/min/1.73 m2
- Severe heart failure (NYHA class III/IV)
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, +86
About this study
Official title: A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of DWP16001 Add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Read the detailed description
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
- Being tested
- DWP16001, Dapagliflozin, DWP16001 Placebo, Dapagliflozin Placebo
- Keywords
- Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action, Hypoglycemic Agents, Physiological Effects of Drugs
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001Drug
Also called DWP16001 tablet
DWP16001 A mg tablet
DapagliflozinDrug
Also called Dapagliflozin tablet
Dapagliflozin tablet
DWP16001 PlaceboDrug
Also called DWP16001 Placebo tablet
DWP16001 Placebo tablet
Dapagliflozin PlaceboDrug
Also called Dapagliflozin Placebo tablet
Dapagliflozin Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | DWP16001 A mg, Dapagliflozin placebo Receives: Drug: DWP16001; Drug: Dapagliflozin Placebo |
| Control group | Active comparator | DWP16001 A mg placebo, Dapagliflozin Receives: Drug: Dapagliflozin; Drug: DWP16001 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Change in HbA1c (%) is assessed with the values measured at the central laboratory
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start28 Sep 2022
- Primary completion26 Feb 2024
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, Dr., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505994
- Sponsor's protocol ID
- DW_DWP16001304_CN
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of DWP16001 Add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
- ClinicalTrials.gov ID
- NCT05505994
- Acronym / sponsor ID
- DW_DWP16001304_CN
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
- Keywords
- Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action, Hypoglycemic Agents, Physiological Effects of Drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 Aug 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.
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Detailed description
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: DWP16001, Drug: Dapagliflozin PlaceboDWP16001 A mg, Dapagliflozin placebo |
| Control group | Active comparator | Drug: Dapagliflozin, Drug: DWP16001 PlaceboDWP16001 A mg placebo, Dapagliflozin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with T2DM aged 18 to 80 years
- Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
- Subjects with BMI of 20-45 kg/m2
- 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 < 60 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 |
|---|---|---|
| DWP16001Also: DWP16001 tabletDWP16001 A mg tablet | Drug | Study group |
| DapagliflozinAlso: Dapagliflozin tabletDapagliflozin tablet | Drug | Control group |
| DWP16001 PlaceboAlso: DWP16001 Placebo tabletDWP16001 Placebo tablet | Drug | Control group |
| Dapagliflozin PlaceboAlso: Dapagliflozin Placebo tabletDapagliflozin Placebo tablet | Drug | Study group |
Primary outcome
Change from baseline in HbA1c
Time frame: at 24 weeks
Change in HbA1c (%) is assessed with the values measured at the central laboratory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Linong Ji, Dr. principal investigator
Peking University People's Hospital
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 and Dapagliflozin in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Daewoong Pharmaceutical Co. LTD. at 1 site in China.
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 4 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 4 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 China. 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?
Results are not available in the source record.
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 baseline in HbA1c (time frame: at 24 weeks). 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 4 Apr 2024.