NCT07289750

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
16mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Aug 2027

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

December 4, 2025

Last Update Submit

March 20, 2026

Conditions

T2DMMAFLD

Keywords

T2DMMAFLD

Outcome Measures

Primary Outcomes (1)

  • hemoglobin A1c

    6 months of treatment

Study Arms (2)

alogliptin and actoplus met

EXPERIMENTAL
Drug: alogliptin and actoplus met

actoplus met

ACTIVE COMPARATOR
Drug: actoplus met

Interventions

alogliptin and actoplus metDRUG

combination of alogliptin and actoplus met

alogliptin and actoplus met
actoplus metDRUG

actoplus met

actoplus met

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe infections, surgeries and other emergency
  • Other types of diabetes
  • Severe cardiovascular, brain, liver and kidney disorders
  • Malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

alogliptin

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03