Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
NCT ID: NCT03349684
Last Updated: 2020-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
287 participants
INTERVENTIONAL
2018-03-05
2019-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Acarbose plus metformin arm
Participants received loose combination of acarbose and metformin 3 times daily.
Acarbose
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
Metformin
500 mg 3 times daily, oral, with the first mouthful of main meal
Placebo
Acarbose matching placebo, oral
Metformin plus placebo arm
Participants received loose combination of placebo and metformin 3 times daily.
Metformin
500 mg 3 times daily, oral, with the first mouthful of main meal
Placebo
Acarbose matching placebo, oral
Interventions
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Acarbose
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
Metformin
500 mg 3 times daily, oral, with the first mouthful of main meal
Placebo
Acarbose matching placebo, oral
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe metabolic diabetic complications
18 Years
79 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, China
The 3rd Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Second Affliated Hospital of Hainan Medical University
Haikou, Hainan, China
Hainan Third People's Hospital (Province Nongken Sanya Hopt)
Sanya, Hainan, China
1st Affiliated Hospital of Henan Science and Technology Univ
Luoyang, Henan, China
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
Taihe Hospital
Shiyan, Hubei, China
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, China
Chenzhou No. 1 People's Hospital
Chenzhou, Hunan, China
1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
Changzhou, Jiangsu, China
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jilin Province People's Hospital
Changchun, Jilin, China
1st Affiliated Hospital of Xi'an Jiaotong Medical University
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Emergency General Hospital
Beijing, , China
Peking Union Medical College Hospital CAMS
Beijing, , China
Beijing Pinggu Hospital
Beijing, , China
Changsha Central Hospital
Changsha, , China
Jiangxi PingXiang people's Hospital
Pingxiang, , China
Shanghai Tenth People's Hospital
Shanghai, , China
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
Tianjin, , China
Countries
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Related Links
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Other Identifiers
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17886
Identifier Type: -
Identifier Source: org_study_id
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