Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients

Study Overview
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Brief Summary
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To demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as compared to metformin monotherapy in the treatment of subjects with T2DM that is inadequately controlled by metformin alone

Official Title
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A Multicenter, Randomized, Double-Blinded, Monotherapy-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of the Acarbose and Metformin in Loose-Dose Combination Compared to Metformin Monotherapy in Subjects WithType 2 Diabetic Mellitus (T2DM) That is Inadequately Controlled by Metformin Monotherapy

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Acarbose
* Drug: Metformin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, aged 18 to less than 80 years Diabetes mellitus type 2, that is insufficently controlled with metformin defined by HbA1c between 7.0 % and 10.0%, inclusive Body mass index between 22 and 45 kg/m^2, inclusive Women and men of reproductive potential must agree to use adequate contraception when sexually active Exclusion Criteria: Fasting plasma glucose > 14.0 mmol/L Severe metabolic diabetic complications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acarbose plus metformin arm<br>Participants received loose combination of acarbose and metformin 3 times daily. | Drug: Acarbose<br>* Uptitrated in the treatment phase from 50 mg per day for 1 week, followed by 100 mg per day for another week, and 150 mg per day for the rest 14 weeks, oral, with the first mouthful of main meal<br>Drug: Metformin<br>* 500 mg 3 times daily, oral, with the first mouthful of main meal<br>Drug: Placebo<br>* Acarbose matching placebo, oral<br>|
| Active Comparator: Metformin plus placebo arm<br>Participants received loose combination of placebo and metformin 3 times daily. | Drug: Metformin<br>* 500 mg 3 times daily, oral, with the first mouthful of main meal<br>Drug: Placebo<br>* Acarbose matching placebo, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in the levels of glycosylated hemoglobin (HbA1c) |  | At baseline and at treatment week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rates | Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5% | At week 16 | 
| Change in 2-hour postprandial plasma glucose (PPG) |  | At baseline and at treatment week 16 | 
| Change in fasting plasma glucose (FPG) levels |  | At baseline and at treatment week 16 | 
| Change in fasting serum insulin levels |  | At baseline and at treatment week 16 | 
| Change in insulin resistance score | Insulin resistance score was calculated based on the homeostasis model assessment (HOMA) model: fasting plasma glucose in mmol/l * fasting serum insulin in mU/L / 22.5. | At baseline and at treatment week 16 | 
| Number of participants with adverse events |  | Up to 16 weeks |