check_circleStudy Completed
Diabetes mellitus, Type 2
Bayer Identifier:
17886
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Loose-dose combination of acarbose and metformin for T2DM in metformin-failure patients
Trial purpose
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
Key Participants Requirements
Sex
AllAge
18 - 79 YearsTrial summary
Enrollment Goal
287Trial Dates
March 2018 - August 2019Phase
Phase 3Could I Receive a placebo
YesProducts
Glucobay M (Acarbose/Metformin, BAY81-9783)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Shandong Provincial Hospital | Jinan, 250021, China |
Withdrawn | The First Affiliated Hospital of Wannan Medical college | Wuhu, 241001, China |
Completed | The First Affiliated Hospital of Anhui Medical University | Hefei, 230022, China |
Completed | Anhui Provincial Hospital | Hefei, 230001, China |
Completed | Emergency General Hospital | Beijing, 100028, China |
Withdrawn | The Affiliated Hospital of Xuzhou Medical College | Xuzhou, 221351, China |
Completed | Huai'an First People's Hospital, Nanjing Medical University | Huai'An, 223300, China |
Completed | 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ | Changzhou, 213003, China |
Completed | Jiangsu Province Hospital | Nanjing, 210029, China |
Withdrawn | Jinan Central Hospital | Jinan, 250013, China |
Withdrawn | General Hospital of Chinese Armed Police Forces | Beijing, 100039, China |
Completed | Beijing Pinggu Hospital | Beijing, 101200, China |
Completed | Hainan Third People's Hospital (Province Nongken Sanya Hopt) | Sanya, 572000, China |
Completed | Changsha Central Hospital | Changsha, 410004, China |
Completed | Jiangxi PingXiang people's Hospital | Pingxiang, 337055, China |
Completed | People's Hospital of Xinjiang Uygur Autonomous Region | Urumqi, 830001, China |
Completed | Peking Union Medical College Hospital CAMS | Beijing, 100730, China |
Completed | Tianjin Union Medicine Centre (People's Hospital of Tianjin) | Tianjin, 300121, China |
Completed | 1st Affiliated Hospital of Xi'an Jiaotong Medical University | Xi'an, 710061, China |
Completed | West China Hospital, Sichuan University | Chengdu, 610041, China |
Completed | The 3rd Affiliated Hospital of Guangzhou Medical University | Guangzhou, 510150, China |
Completed | The First Affiliated Hospital of Sun Yat-Sen University | guangzhou, 510080, China |
Withdrawn | 2nd affiliated Hos. Harbin Medical University | Harbin, 150001, China |
Withdrawn | Tangshan Gongren Hospital | Tangshan, 063000, China |
Completed | Jilin Province People's Hospital | Changchun, 130021, China |
Completed | Northern Jiangsu People's Hospital | Yangzhou, 225001, China |
Completed | Chenzhou No. 1 People's Hospital | Chenzhou, 423000, China |
Completed | Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. | Wuhan, 430030, China |
Completed | SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV. | Guangzhou, 510120, China |
Completed | The first affiliated hospital of Zhengzhou University | Zhengzhou, 450052, China |
Completed | Affiliated Hospital of Jining Medical University | Jining, 272000, China |
Completed | 1st Affiliated Hospital of Henan Science and Technology Univ | Luoyang, 471000, China |
Completed | Taihe Hospital | Shiyan, 442008, China |
Completed | The Second Affliated Hospital of Hainan Medical University | Haikou, 570311, China |
Withdrawn | The 4th Affiliated Hospital of Harbin Medical University | Harbin, 150001, China |
Completed | Shanghai Tenth People's Hospital | Shanghai, 200072, China |
Primary Outcome
- Absolute change in the levels of glycosylated hemoglobin (HbA1c)date_rangeTime Frame:At baseline and at treatment week 16
Secondary Outcome
- Responder ratesDefined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5%date_rangeTime Frame:At week 16
- Change in 2-hour postprandial plasma glucose (PPG)date_rangeTime Frame:At baseline and at treatment week 16
- Change in fasting plasma glucose (FPG) levelsdate_rangeTime Frame:At baseline and at treatment week 16
- Change in fasting serum insulin levelsdate_rangeTime Frame:At baseline and at treatment week 16
- Change in insulin resistance scoreInsulin 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.date_rangeTime Frame:At baseline and at treatment week 16
- Number of participants with adverse eventsdate_rangeTime Frame:Up to 16 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2