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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acarbose plus metformin arm | Experimental | Participants received loose combination of acarbose and metformin 3 times daily. |
|
| Metformin plus placebo arm | Active Comparator | Participants received loose combination of placebo and metformin 3 times daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in the levels of glycosylated hemoglobin (HbA1c) | At baseline and at treatment week 16 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China | ||
| The First Affiliated Hospital of Anhui Medical University |
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| Metformin | Drug | 500 mg 3 times daily, oral, with the first mouthful of main meal |
|
| Placebo | Drug | Acarbose matching placebo, oral |
|
| 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 |
| Hefei |
| Anhui |
| 230022 |
| China |
| The First Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
| Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ. | Guangzhou | Guangdong | 510120 | China |
| The 3rd Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510150 | China |
| The Second Affliated Hospital of Hainan Medical University | Haikou | Hainan | 570311 | China |
| Hainan Third People's Hospital (Province Nongken Sanya Hopt) | Sanya | Hainan | 572000 | China |
| 1st Affiliated Hospital of Henan Science and Technology Univ | Luoyang | Henan | 471000 | China |
| The first affiliated hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Taihe Hospital | Shiyan | Hubei | 442008 | China |
| Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. | Wuhan | Hubei | 430030 | China |
| Chenzhou No. 1 People's Hospital | Chenzhou | Hunan | 423000 | China |
| 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ | Changzhou | Jiangsu | 213003 | China |
| Huai'an First People's Hospital, Nanjing Medical University | Huai'an | Jiangsu | 223300 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | 225001 | China |
| Jilin Province People's Hospital | Changchun | Jilin | 130021 | China |
| 1st Affiliated Hospital of Xi'an Jiaotong Medical University | Xi'an | Shaanxi | 710061 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Affiliated Hospital of Jining Medical University | Jining | Shandong | 272000 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang | 830001 | China |
| Emergency General Hospital | Beijing | 100028 | China |
| Peking Union Medical College Hospital CAMS | Beijing | 100730 | China |
| Beijing Pinggu Hospital | Beijing | 101200 | China |
| Changsha Central Hospital | Changsha | 410004 | China |
| Jiangxi PingXiang people's Hospital | Pingxiang | 337055 | China |
| Shanghai Tenth People's Hospital | Shanghai | 200072 | China |
| Tianjin Union Medicine Centre (People's Hospital of Tianjin) | Tianjin | 300121 | China |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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