Type2 DiabetesPhase 3NCT06329674
Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients
A Phase 3 study testing AJU-A51, A51R2 and A51R3 in people with Type2 Diabetes, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- AJU-A51, A51R2 and A51R3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2021to 13 Jun 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who voluntarily signed the informed consent to participate in this study.
- Adults aged 19-75 years.
- Those diagnosed with type 2 diabetes mellitus.
- 7% ≤ HbA1c ≤ 10.5%
- FPG ≤ 270 mg/dL
- BMI ≤ 40 kg/㎡
- Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.
Who cannot join
- Those who suffered from acute or chronic metabolic acidosis, lactic acidosis and diabetic ketoacidosis.
- Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- Those with heart failure (NYHA class II~IV) or who had suffered from heart failure.
- Those with a history of malignant tumor within 5 years
- Those who have a clinically significant liver disease
- Those who have a clinically significant renal disease
Show all 12Show fewer
- SBP > 180 mmHg or DBP > 110 mmHg
- Those who had allergic reaction to main ingredients or components of the investigational products.
- Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
- Females who are pregnant or breastfeeding.
- AST or ALT ≥ LRN*3
- TG ≥ 500 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Efficacy and Safety of the Combination of A51R3 and AJU-A51 Compared With the Combination of A51R3 and A51R2 in Patients With Type 2 Diabetes Mellitus
A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2
- Conditions
- Type2 Diabetes
- Being tested
- AJU-A51, A51R2, A51R3, AJU-A51 Placebo, A51R2 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJU-A51Drug
Subjects take the investigational products once a day for 24 weeks.
A51R2Drug
Subjects take the investigational products once a day for 24 weeks.
A51R3Drug
Subjects take the investigational products once a day for 24 weeks.
AJU-A51 PlaceboDrug
Subjects take the investigational products once a day for 24 weeks.
A51R2 PlaceboDrug
Subjects take the investigational products once a day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AJU-A51+A51R2 placebo+A51R3 | Experimental | Not described Receives: Drug: AJU-A51; Drug: A51R3; Drug: A51R2 Placebo |
| AJU-A51 placebo+A51R2+A51R3 | Experimental | Not described Receives: Drug: A51R2; Drug: A51R3; Drug: AJU-A51 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c
Changes in HbA1c at the 24th week after the administration of investigational products from the baseline
Measured: 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start27 Apr 2021
- Primary completion1 Dec 2022
- Study completion13 Jun 2023
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329674
- Sponsor's protocol ID
- 20DM30203
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong JH, Kim MJ, Min KW, Won JC, Kim TN, Lee BW, Kang JG, Kim JH, Park JH, Ku BJ, Lee CB, Kim SY, Shon HS, Lee WJ, Park JY. Efficacy and safety of a fixed-dose combination of dapagliflozin and linagliptin (AJU-A51) in patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, parallel-group, placebo-controlled phase III study. Diabetes Obes Metab. 2025 Jan;27(1):81-91. doi: 10.1111/dom.15985. Epub 2024 Oct 7.
PubMed 39375869
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of the Combination of A51R3 and AJU-A51 Compared With the Combination of A51R3 and A51R2 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06329674
- Acronym / sponsor ID
- 20DM30203
- Conditions
- Type2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 26 Mar 2024 (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, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2
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 |
|---|---|---|
| AJU-A51+A51R2 placebo+A51R3 | Experimental | Drug: AJU-A51, Drug: A51R3, Drug: A51R2 Placebo |
| AJU-A51 placebo+A51R2+A51R3 | Experimental | Drug: A51R2, Drug: A51R3, Drug: AJU-A51 Placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Those who voluntarily signed the informed consent to participate in this study.
- Adults aged 19-75 years.
- Those diagnosed with type 2 diabetes mellitus.
- 7% ≤ HbA1c ≤ 10.5%
- FPG ≤ 270 mg/dL
Key exclusion criteria (12 listed)
- Those who suffered from acute or chronic metabolic acidosis, lactic acidosis and diabetic ketoacidosis.
- Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- Those with heart failure (NYHA class II~IV) or who had suffered from heart failure.
- Those with a history of malignant tumor within 5 years
- Those who have a clinically significant liver disease
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 |
|---|---|---|
| AJU-A51Subjects take the investigational products once a day for 24 weeks. | Drug | AJU-A51+A51R2 placebo+A51R3 |
| A51R2Subjects take the investigational products once a day for 24 weeks. | Drug | AJU-A51 placebo+A51R2+A51R3 |
| A51R3Subjects take the investigational products once a day for 24 weeks. | Drug | AJU-A51 placebo+A51R2+A51R3, AJU-A51+A51R2 placebo+A51R3 |
| AJU-A51 PlaceboSubjects take the investigational products once a day for 24 weeks. | Drug | AJU-A51 placebo+A51R2+A51R3 |
| A51R2 PlaceboSubjects take the investigational products once a day for 24 weeks. | Drug | AJU-A51+A51R2 placebo+A51R3 |
Primary outcome
Changes in HbA1c
Time frame: 24th week
Changes in HbA1c at the 24th week after the administration of investigational products from the baseline
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 26 Mar 2024.
- Derived from this study: PubMed 39375869Hong JH, Kim MJ, Min KW, Won JC, Kim TN, Lee BW, Kang JG, Kim JH, Park JH, Ku BJ, Lee CB, Kim SY, Shon HS, Lee WJ, Park JY. Efficacy and safety of a fixed-dose combination of dapagliflozin and linagliptin (AJU-A51) in patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, parallel-group, placebo-controlled phase III study. Diabetes Obes Metab. 2025 Jan;27(1):81-91. doi: 10.1111/dom.15985. Epub 2024 Oct 7.
- 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.
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 AJU-A51, A51R2 and A51R3 in people with Type2 Diabetes, run by AJU Pharm 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 12 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 26 Mar 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 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?
Changes in HbA1c (time frame: 24th week). 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 NCT06329674, 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 26 Mar 2024.