Trial Condition(s):

Diabetes Mellitus, Type 2

Loose-dose combination of acarbose and metformin for T2DM in metformin-failure patients

Bayer Identifier:

17886

ClinicalTrials.gov Identifier:

NCT03349684

EudraCT Number:

Not Available

Study Completed

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

Inclusion Criteria
-Males and females, aged 18 to less than 80 years
-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
-Fasting plasma glucose > 14.0 mmol/L
-Severe metabolic diabetic complications

Trial Summary

Enrollment Goal
287
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Glucobay M (Acarbose/Metformin, BAY81-9783)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Shandong Provincial Hospital

Jinan, China, 250021

Status
Completed
 
Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, China, 230022

Status
Completed
 
Locations

Anhui Provincial Hospital

Hefei, China, 230001

Status
Completed
 
Locations

Emergency General Hospital

Beijing, China, 100028

Status
Completed
 
Locations

Huai'an First People's Hospital, Nanjing Medical University

Huai'An, China, 223300

Status
Completed
 
Locations

1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ

Changzhou, China, 213003

Status
Completed
 
Locations

Jiangsu Province Hospital

Nanjing, China, 210029

Status
Completed
 
Locations

Beijing Pinggu Hospital

Beijing, China, 101200

Status
Completed
 
Locations

Hainan Third People's Hospital (Province Nongken Sanya Hopt)

Sanya, China, 572000

Status
Completed
 
Locations

Changsha Central Hospital

Changsha, China, 410004

Status
Completed
 
Locations

Jiangxi PingXiang people's Hospital

Pingxiang, China, 337055

Status
Completed
 
Locations

People's Hospital of Xinjiang Uygur Autonomous Region

Urumqi, China, 830001

Status
Completed
 
Locations

Peking Union Medical College Hospital CAMS

Beijing, China, 100730

Status
Completed
 
Locations

Tianjin Union Medicine Centre (People's Hospital of Tianjin)

Tianjin, China, 300121

Status
Completed
 
Locations

1st Affiliated Hospital of Xi'an Jiaotong Medical University

Xi'an, China, 710061

Status
Completed
 
Locations

West China Hospital, Sichuan University

Chengdu, China, 610041

Status
Completed
 
Locations

The 3rd Affiliated Hospital of Guangzhou Medical University

Guangzhou, China, 510150

Status
Completed
 
Locations

The First Affiliated Hospital of Sun Yat-Sen University

guangzhou, China, 510080

Status
Completed
 
Locations

Jilin Province People's Hospital

Changchun, China, 130021

Status
Completed
 
Locations

Northern Jiangsu People's Hospital

Yangzhou, China, 225001

Status
Completed
 
Locations

Chenzhou No. 1 People's Hospital

Chenzhou, China, 423000

Status
Completed
 
Locations

Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

Wuhan, China, 430030

Status
Completed
 
Locations

SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV.

Guangzhou, China, 510120

Status
Completed
 
Locations

The first affiliated hospital of Zhengzhou University

Zhengzhou, China, 450052

Status
Completed
 
Locations

Affiliated Hospital of Jining Medical University

Jining, China, 272000

Status
Completed
 
Locations

1st Affiliated Hospital of Henan Science and Technology Univ

Luoyang, China, 471000

Status
Completed
 
Locations

Taihe Hospital

Shiyan, China, 442008

Status
Completed
 
Locations

The Second Affliated Hospital of Hainan Medical University

Haikou, China, 570311

Status
Completed
 
Locations

Shanghai Tenth People's Hospital

Shanghai, China, 200072

Status
Completed
 

Trial Design