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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes; Blood Glucose Fluctuation
• Interventions: Drug: Metformin plus pioglitazone; Drug: Acarbose

• Registration Number: NCT05629806
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-10
• Status Verified: 2022-11
• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-11-29
• Last Update Posted: 2022-11-29
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin plus pioglitazone	Acarbose	-
Acarbose	Acarbose	-
Metformin plus pioglitazone	Metformin plus pioglitazone	-
Acarbose	Metformin plus pioglitazone	-

Primary Outcome Measures

Name	Time	Method
Blood glucose fluctuation	week 24	change from baseline blood glucsoe fluctuation at end of study

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical Univesity; 🇨🇳 Nanjing, China