Back to resultsEffect of Acarbose and Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes, Blood Glucose Fluctuation
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Metformin plus pioglitazone
Acarbose
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
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.
Sites / Locations
- Nanjing First Hospital, Nanjing Medical UnivesityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Metformin plus pioglitazone
Acarbose
Arm Description
Outcomes
Primary Outcome Measures
Blood glucose fluctuation
change from baseline blood glucsoe fluctuation at end of study
Secondary Outcome Measures
Full Information
NCT ID
NCT05629806
First Posted
November 18, 2022
Last Updated
November 28, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05629806
Brief Title
Effect of Acarbose and Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes
Official Title
Effect of Acarbose and Fixed Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes Receiving Anti-diabetic Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Blood Glucose Fluctuation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin plus pioglitazone
Arm Type
Active Comparator
Arm Title
Acarbose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin plus pioglitazone
Intervention Description
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
Intervention Name(s)
Acarbose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood glucose fluctuation
Description
change from baseline blood glucsoe fluctuation at end of study
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Ma, professor
Phone
18951670116
Email
majianhua196503@126.com
Facility Information:
Facility Name
Nanjing First Hospital, Nanjing Medical Univesity
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Acarbose and Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes
We'll reach out to this number within 24 hrs