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The Effect of Alogliptin Combined With Actoplus Met on Glucose and Lipid Metabolism and Pancreatic Function in Patients With T2DM Complicated With MAFLD.

NCT ID: NCT07289750

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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T2DM MAFLD

Keywords

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T2DM MAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

Group Type EXPERIMENTAL

combination treatment

Intervention Type DRUG

combination of alogliptin and actoplus met

control group

Group Type ACTIVE_COMPARATOR

alone treatment

Intervention Type DRUG

actoplus met

Interventions

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combination treatment

combination of alogliptin and actoplus met

Intervention Type DRUG

alone treatment

actoplus met

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1.Meet the T2DM diagnosis criteria of China's Diabetes Prevention and Control Guidelines (2024 Edition) 2.Meet the MAFLD diagnosis criteria of Guideline for the Prevention and Treatment of Metabolic Dysfunction-associated Fatty Liver Disease (Version 2024) 3.HbA1c: 6.5-9.5%，BMI: 19-35 kg/m2。 4.No hypoglycemic drugs or insulin have been used within half a year.

Exclusion Criteria

* 1.Severe infections, surgeries and other stressful situations. 2.Other types of diabetes. 3.Severe cardiovascular, brain, liver and kidney disorders. 4.Acute complications of diabetes. 5.Malignant tumor
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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KY-2025-242

Identifier Type: -

Identifier Source: org_study_id