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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status and phase: Not yet enrolling; Phase 4

Conditions: T2DM; MAFLD

Treatments: Drug: combination treatment; Drug: alone treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07289750

KY-2025-242

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

experimental group

Experimental group

Treatment:

Drug: combination treatment

control group

Active Comparator group

Treatment:

Drug: alone treatment