NCT05629806

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

November 18, 2022

Last Update Submit

November 28, 2022

Conditions

Type 2 DiabetesBlood Glucose Fluctuation

Outcome Measures

Primary Outcomes (1)

  • Blood glucose fluctuation

    change from baseline blood glucsoe fluctuation at end of study

    week 24

Study Arms (2)

Metformin plus pioglitazone

ACTIVE COMPARATOR
Drug: Metformin plus pioglitazoneDrug: Acarbose

Acarbose

ACTIVE COMPARATOR
Drug: Metformin plus pioglitazoneDrug: Acarbose

Interventions

Metformin plus pioglitazoneDRUG

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.

AcarboseMetformin plus pioglitazone
AcarboseDRUG

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.

AcarboseMetformin plus pioglitazone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MetforminPioglitazoneAcarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsThiazolidinedionesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Central Study Contacts

Jianhua Ma, professor

CONTACT

18951670116majianhua196503@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 29, 2022

Study Start

April 10, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)