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

NCT05629806 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-11-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-10
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629806 on ClinicalTrials.gov