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

Type 2 Diabetes Clinical Trial

Official title:

Effect of Acarbose and Fixed Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes Receiving Anti-diabetic Monotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629806
• Other study ID #: KY20220314-02
• Status: Recruiting
• Phase: Phase 3
• Start date: April 10, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jianhua Ma, professor
• Phone: 18951670116
• Email: majianhua196503[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Metformin plus pioglitazone
After the screening period, eligible subjects were admitted to two tablets of fixed mixture of metformin plus pioglitazone (15mg pioglitazone plus 500mg metformin) for 12 weeks. Then the subjects were titrated onto the alternative treatment of 50mg acarbose three times daily for 12 weeks. During this timeframe, all patients were instructed to monitor their blood glucose fluctuations with a FreeStyle Libre Pro Sensor (FGM system) before and after the study and the time point of drug replacement.
• Acarbose
After the screening period, eligible subjects were admitted to 50mg acarbose three times daily for 12 weeks. Then the subjects were titrated onto the alternative treatment of two tablets of fixed mixture of metformin plus pioglitazone (15mg pioglitazone plus 500mg metformin) for 12 weeks. During this timeframe, all patients were instructed to monitor their blood glucose fluctuations with a FreeStyle Libre Pro Sensor (FGM system) before and after the study and the time point of drug replacement.

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical Univesity	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose fluctuation	change from baseline blood glucsoe fluctuation at end of study	week 24