Type2 DiabetesPhase 3NCT04170998
Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
A Phase 3 study testing Evogliptin 5mg, Dapagliflozin 10mg and Metformin ≥ 1000mg in people with Type2 Diabetes, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Evogliptin 5mg, Dapagliflozin 10mg 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
- 283 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2020to 8 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 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
- Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy
- Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit
- Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit
- Subjects with 7.0%≤HbA1c≤10.5% at screening visit
- Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
- Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit
Who cannot join
- Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis
- patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- Patients with severe infectious disease or severe traumatic systemic disorders
- End stage renal disease or dialysis patients
- Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St, Mary's Hospital,The Catholic University of Korea
Seoul
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
- Conditions
- Type2 Diabetes
- Being tested
- Evogliptin 5mg, Evogliptin Placebo, Dapagliflozin 10mg, Metformin ≥ 1000mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evogliptin 5mgDrug
Also called Suganon
Participants receive Evogliptin 5mg orally once a day
Evogliptin PlaceboDrug
Also called Placebo
Participants receive placebo to match Evogliptin 5mg orally once a day
Dapagliflozin 10mgDrug
Also called Forxiga
Participants receive Dapagliflozin orally once a day
Metformin ≥ 1000mgDrug
Metformin are administered at the same dose and formulation.
| Study group | Role | What they receive |
|---|---|---|
| Evogliptin 5mg group | Experimental | Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d Receives: Drug: Evogliptin 5mg; Drug: Dapagliflozin 10mg; Drug: Metformin ≥ 1000mg |
| Evogliptin Placebo group | Placebo comparator | Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d Receives: Drug: Evogliptin Placebo; Drug: Dapagliflozin 10mg; Drug: Metformin ≥ 1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c (%) After 24 weeks
Measured: 24 weeks
Secondary outcomes (3)
Change from baseline in FPG(mg/dL) After 24 weeks
Measured: 24 weeks
Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks
Measured: 24 weeks
Change from baseline in 7-point SMBG After 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start2 Jan 2020
- Primary completion28 Jun 2021
- Study completion8 Dec 2021
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 Type2 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 283 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
- NCT04170998
- Sponsor's protocol ID
- DA1229_DMTD_III
- Status last verified
- Dec 2021
- First submitted
- 13 Nov 2019
- Last updated
- 10 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moon JS, Park IR, Kim HJ, Chung CH, Won KC, Han KA, Park CY, Won JC, Kim DJ, Koh GP, Kim ES, Yu JM, Hong EG, Lee CB, Yoon KH. Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension. Diabetes Metab J. 2023 Nov;47(6):808-817. doi: 10.4093/dmj.2022.0387. Epub 2023 Sep 26.
PubMed 37750183
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. 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 Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT04170998
- Acronym / sponsor ID
- DA1229_DMTD_III
- Conditions
- Type2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 20 Nov 2019 (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 Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evogliptin 5mg group | Experimental | Drug: Evogliptin 5mg, Drug: Dapagliflozin 10mg, Drug: Metformin ≥ 1000mgEvogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d |
| Evogliptin Placebo group | Placebo comparator | Drug: Evogliptin Placebo, Drug: Dapagliflozin 10mg, Drug: Metformin ≥ 1000mgEvogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with Type II diabetes mellitus aged 19 years or older
- Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy
- Subjects with 7.0%≤HbA1c≤10.5% at screening visit
- Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
- Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit
Key exclusion criteria (6 listed)
- Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis
- patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- Patients with severe infectious disease or severe traumatic systemic disorders
- End stage renal disease or dialysis patients
- 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 |
|---|---|---|
| Evogliptin 5mgAlso: SuganonParticipants receive Evogliptin 5mg orally once a day | Drug | Evogliptin 5mg group |
| Evogliptin PlaceboAlso: PlaceboParticipants receive placebo to match Evogliptin 5mg orally once a day | Drug | Evogliptin Placebo group |
| Dapagliflozin 10mgAlso: ForxigaParticipants receive Dapagliflozin orally once a day | Drug | Evogliptin 5mg group, Evogliptin Placebo group |
| Metformin ≥ 1000mgMetformin are administered at the same dose and formulation. | Drug | Evogliptin 5mg group, Evogliptin Placebo group |
Primary outcome
Change from baseline in HbA1c (%) After 24 weeks
Time frame: 24 weeks
3 secondary outcomes
Change from baseline in FPG(mg/dL) After 24 weeks
Time frame: 24 weeks
Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks
Time frame: 24 weeks
Change from baseline in 7-point SMBG After 24 weeks
Time frame: 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 10 Dec 2021.
- Derived from this study: PubMed 37750183Moon JS, Park IR, Kim HJ, Chung CH, Won KC, Han KA, Park CY, Won JC, Kim DJ, Koh GP, Kim ES, Yu JM, Hong EG, Lee CB, Yoon KH. Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension. Diabetes Metab J. 2023 Nov;47(6):808-817. doi: 10.4093/dmj.2022.0387. Epub 2023 Sep 26.
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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 Evogliptin 5mg, Dapagliflozin 10mg and Metformin ≥ 1000mg in people with Type2 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 7 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 10 Dec 2021. 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 baseline in HbA1c (%) After 24 weeks (time frame: 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 NCT04170998, 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 10 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.