Effect of Acarbose and Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes

Nanjing Medical University

Status and phase

Enrolling

Phase 3

Conditions

Blood Glucose Fluctuation

Type 2 Diabetes

Treatments

Drug: Acarbose

Drug: Metformin plus pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT05629806

KY20220314-02

Details and patient eligibility

About

Monotherapy with DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues frequently failed to maintain blood glucose in patients with type 2 diabtes. It was critical to determine which was more suitable of acarbose versus metformin plus pioglitazone.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing to participate in this present study;
Patients with type 2 diabetes receiving stable monotherapy of DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues for more than 3 months;
Screening glycated hemoglobin (HbA1c) between 7.0% and 10.0%;
Regular diet and exercise;
Body mass index (BMI) ≥ 18.5 kg/m2

Exclusion criteria

Intolerance of metformin, pioglitazone and acarbose;
Severe liver disease or elevated transaminases (2.5-fold the upper limit);
Renal dysfunction or elevated creatinine (1.3-fold the upper limit);
Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
Infection or stress state in the past 4 weeks;
Pregnancy or lactation;
Patients otherwise adjudged by the investigator to be inappropriate for inclusion into the study.