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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes, Blood Glucose Fluctuation

Intervention / Treatment
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* Drug: Metformin plus pioglitazone
* Drug: Acarbose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin plus pioglitazone<br> | Drug: Metformin plus pioglitazone<br>* 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.<br>Drug: Acarbose<br>* 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.<br>|
| Active Comparator: Acarbose<br> | Drug: Metformin plus pioglitazone<br>* 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.<br>Drug: Acarbose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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