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Clinical Trial Details

Trial ID: L4982
Source ID: NCT03349684
Associated Drug: Acarbose
Title: Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Acarbose|DRUG: Metformin|DRUG: Placebo
Outcome Measures: Primary: Absolute change in the levels of glycosylated hemoglobin (HbA1c), At baseline and at treatment week 16 | Secondary: 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
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 287
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-03-05
Completion Date: 2019-08-21
Results First Posted:
Last Update Posted: 2020-08-05
Locations: Anhui Provincial Hospital, Hefei, Anhui, 230001, China|The First Affiliated Hospital of Anhui Medical University, 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, Urumqi, 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
URL: https://clinicaltrials.gov/show/NCT03349684

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details