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

Sponsor
Nanjing First Hospital, Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05629806
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
13.7
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Acarbose and Fixed Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes Receiving Anti-diabetic Monotherapy
Actual Study Start Date :
Apr 10, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

  1. Blood glucose fluctuation [week 24]

    change from baseline blood glucsoe fluctuation at end of study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanjing First Hospital, Nanjing Medical Univesity Nanjing China

Sponsors and Collaborators

  • Nanjing First Hospital, Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05629806
Other Study ID Numbers:
  • KY20220314-02
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metformin
Pioglitazone
Acarbose

Study Results

No Results Posted as of Nov 29, 2022