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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Blood Glucose Fluctuation
• Intervention / Treatment: Drug: Metformin plus pioglitazone; Drug: Acarbose

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jianhua Ma, professor; Phone Number: 18951670116; Email: majianhua196503@126.com

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • Nanjing First Hospital, Nanjing Medical Univesity
    • Contact: Jianhua Ma, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acarbose	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.; 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.
Active Comparator: Metformin plus pioglitazone	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose fluctuation	change from baseline blood glucsoe fluctuation at end of study	week 24

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Metformin; Pioglitazone; Acarbose
• Other Study ID Numbers: KY20220314-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No