Type 2 DiabetesPhase 3NCT04356742
Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
A Phase 3 study testing Dapagliflozin 10mg, Evogliptin 5mg and Metformin≥1000mg in people with Type 2 Diabetes, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dapagliflozin 10mg, Evogliptin 5mg and Metformin≥1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2020to 23 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type II diabetes mellitus aged 19 years or older
- Patients who had taken metformin(≥1000mg/day) and DPP(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit
- Patients with fasting plasma glucose≤250mg/dL at the screening visit
- Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
- Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
Who cannot join
- Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
- Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
- Patients with severe infectious disease or severe traumatic systemic disorders
- Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
- Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.
- Conditions
- Type 2 Diabetes
- Being tested
- Dapagliflozin 10mg, Placebo, Evogliptin 5mg, Metformin≥1000mg
- 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.
Dapagliflozin 10mgDrug
Also called Forxiga
Dapagliflozin 10mg, orally, once daily, up to 24weeks
PlaceboDrug
Dapagliflozin Placebo, orally, once daily, up to 24weeks
Evogliptin 5mgDrug
Also called Suganon
Evogliptin 5mg, orally, once daily for background therapy
Metformin≥1000mgDrug
Metformin≥1000mg, orally, daily for background therapy
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg + Evogliptin 5mg + Metformin | Experimental | Not described Receives: Drug: Dapagliflozin 10mg; Drug: Evogliptin 5mg; Drug: Metformin≥1000mg |
| Dapagliflozin Placebo + Evogliptin 5mg + Metformin | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Evogliptin 5mg; Drug: Metformin≥1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in HbA1c (%) after 24 weeks
Measured: Baseline, 24 weeks
Secondary outcomes (3)
Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks
Measured: Baseline, 24 weeks
Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks
Measured: Baseline, 24 weeks
Change from the baseline in weight after 24 weeks
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start26 May 2020
- Primary completion23 Feb 2022
- Study completion23 Feb 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 Type 2 DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356742
- Sponsor's protocol ID
- DA1229_DMTD2_III
- Status last verified
- Mar 2022
- First submitted
- 20 Apr 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeong IK, Choi KM, Han KA, Kim KA, Kim IJ, Han SJ, Lee WY, Yoo SJ. Efficacy and safety of dapagliflozin add-on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2024 Nov;26(11):5065-5077. doi: 10.1111/dom.15838. Epub 2024 Sep 2.
PubMed 39223856
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT04356742
- Acronym / sponsor ID
- DA1229_DMTD2_III
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2020 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 22 Apr 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.
This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg + Evogliptin 5mg + Metformin | Experimental | Drug: Dapagliflozin 10mg, Drug: Evogliptin 5mg, Drug: Metformin≥1000mg |
| Dapagliflozin Placebo + Evogliptin 5mg + Metformin | Placebo comparator | Drug: Placebo, Drug: Evogliptin 5mg, Drug: Metformin≥1000mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type II diabetes mellitus aged 19 years or older
- Patients who had taken metformin(≥1000mg/day) and DPP(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit
- Patients with fasting plasma glucose≤250mg/dL at the screening visit
- Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
- Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
Key exclusion criteria (6 listed)
- Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
- Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
- Patients with severe infectious disease or severe traumatic systemic disorders
- Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
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 |
|---|---|---|
| Dapagliflozin 10mgAlso: ForxigaDapagliflozin 10mg, orally, once daily, up to 24weeks | Drug | Dapagliflozin 10mg + Evogliptin 5mg + Metformin |
| PlaceboDapagliflozin Placebo, orally, once daily, up to 24weeks | Drug | Dapagliflozin Placebo + Evogliptin 5mg + Metformin |
| Evogliptin 5mgAlso: SuganonEvogliptin 5mg, orally, once daily for background therapy | Drug | Dapagliflozin 10mg + Evogliptin 5mg + Metformin, Dapagliflozin Placebo + Evogliptin 5mg + Metformin |
| Metformin≥1000mgMetformin≥1000mg, orally, daily for background therapy | Drug | Dapagliflozin 10mg + Evogliptin 5mg + Metformin, Dapagliflozin Placebo + Evogliptin 5mg + Metformin |
Primary outcome
Change from the baseline in HbA1c (%) after 24 weeks
Time frame: Baseline, 24 weeks
3 secondary outcomes
Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks
Time frame: Baseline, 24 weeks
Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks
Time frame: Baseline, 24 weeks
Change from the baseline in weight after 24 weeks
Time frame: Baseline, 24 weeks
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 22 Mar 2022.
- Derived from this study: PubMed 39223856Jeong IK, Choi KM, Han KA, Kim KA, Kim IJ, Han SJ, Lee WY, Yoo SJ. Efficacy and safety of dapagliflozin add-on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2024 Nov;26(11):5065-5077. doi: 10.1111/dom.15838. Epub 2024 Sep 2.
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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 Dapagliflozin 10mg, Evogliptin 5mg and Metformin≥1000mg in people with Type 2 Diabetes, run by Dong-A ST 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 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 22 Mar 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. 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?
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 the baseline in HbA1c (%) after 24 weeks (time frame: Baseline, 24 weeks). 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 NCT04356742, 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 22 Mar 2022.