check_circleStudy Completed
Diabetes mellitus, Type 2
Bayer Identifier:infoA unique number for a trial given by Bayer.
17886
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
287The overall number of participants needed for a trial.
Trial Dates info
March 2018 - August 2019Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
YesA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Glucobay M (Acarbose/Metformin, BAY81-9783)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where 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Withdrawn | The First Affiliated Hospital of Wannan Medical college | Wuhu, 241001, China |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Withdrawn | The Affiliated Hospital of Xuzhou Medical College | Xuzhou, 221351, China |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 OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Absolute change in the levels of glycosylated hemoglobin (HbA1c)date_rangeTime Frame:At baseline and at treatment week 16
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 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 info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
2A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.