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

NCT ID: NCT05629806

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-10
• Study Completion Date: 2023-05-31

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.

Conditions

Type 2 Diabetes; Blood Glucose Fluctuation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin plus pioglitazone

Group Type: ACTIVE_COMPARATOR

Metformin plus pioglitazone

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Acarbose

Group Type: ACTIVE_COMPARATOR

Metformin plus pioglitazone

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianhua Ma, professor

Role: CONTACT

majianhua196503@126.com

18951670116

Facility Contacts

Jianhua Ma, Professor

Role: primary

Other Identifiers

KY20220314-02

Identifier Type: -

Identifier Source: org_study_id