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: alogliptin and actoplus met; Drug: actoplus met

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

• 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

Exclusion criteria

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

alogliptin and actoplus met

Experimental group

Treatment:

Drug: alogliptin and actoplus met

actoplus met

Active Comparator group

Treatment:

Drug: actoplus met