T2DMPhase 4NCT07289750
The Effect of Alogliptin Combined With Actoplus Met on Glucose and Lipid Metabolism and Pancreatic Function in Patients With T2DM Complicated With MAFLD
A Phase 4 study testing alogliptin and actoplus met and actoplus met in people with T2DM and MAFLD, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
To compare the efficacy and safety of the combination of alogliptin and actoplus met with that of actoplus met alone in improving the glucose and lipid metabolism and pancreatic function in T2DM patients complicated with MAFLD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- alogliptin and actoplus met and actoplus met
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of T2DM
- Clinical diagnosis of MAFLD
- HbA1c: 6.5-9.5%
- BMI: 19-35 kg/m2
- No hypoglycemic drugs or insulin have been used within half a year
Who cannot join
- Severe infections, surgeries and other emergency
- Other types of diabetes
- Severe cardiovascular, brain, liver and kidney disorders
- Malignant tumor
About this study
Official title: The Effect of Alogliptin Combined With Pioglitazone and Metformin Hydrochloride Tablets on Glucose and Lipid Metabolism and Islet Function in Patients With Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-associated Fatty Liver Disease
To compare the efficacy and safety of the combination of alogliptin and actoplus met with that of actoplus met alone in improving the glucose and lipid metabolism and pancreatic function in T2DM patients complicated with MAFLD.
- Being tested
- alogliptin and actoplus met, actoplus met
- Keywords
- T2DM, MAFLD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alogliptin and actoplus metDrug
combination of alogliptin and actoplus met
actoplus metDrug
actoplus met
| Study group | Role | What they receive |
|---|---|---|
| alogliptin and actoplus met | Experimental | Not described Receives: Drug: alogliptin and actoplus met |
| actoplus met | Active comparator | Not described Receives: Drug: actoplus met |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1c
Measured: 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 May 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289750
- Sponsor's protocol ID
- KY-2025-242
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alogliptin Combined With Pioglitazone and Metformin Hydrochloride Tablets on Glucose and Lipid Metabolism and Islet Function in Patients With Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07289750
- Acronym / sponsor ID
- KY-2025-242
- Keywords
- T2DM, MAFLD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Dec 2025 (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.
To compare the efficacy and safety of the combination of alogliptin and actoplus met with that of actoplus met alone in improving the glucose and lipid metabolism and pancreatic function in T2DM patients complicated with MAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alogliptin and actoplus met | Experimental | Drug: alogliptin and actoplus met |
| actoplus met | Active comparator | Drug: actoplus met |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of T2DM
- Clinical diagnosis of MAFLD
- HbA1c: 6.5-9.5%
- BMI: 19-35 kg/m2
- No hypoglycemic drugs or insulin have been used within half a year
Key exclusion criteria (4 listed)
- Severe infections, surgeries and other emergency
- Other types of diabetes
- Severe cardiovascular, brain, liver and kidney disorders
- Malignant tumor
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 |
|---|---|---|
| alogliptin and actoplus metcombination of alogliptin and actoplus met | Drug | alogliptin and actoplus met |
| actoplus metactoplus met | Drug | actoplus met |
Primary outcome
hemoglobin A1c
Time frame: 6 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alogliptin and actoplus met and actoplus met in people with T2DM and MAFLD, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
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 4 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: opening soon, as of the sponsor's last update on 24 Mar 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
hemoglobin A1c (time frame: 6 months of treatment). 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 24 Mar 2026.