Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
A Multicenter, Randomized, Double-Blinded, Monotherapy-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of the Acarbose and Metformin in Loose-Dose Combination Compared to Metformin Monotherapy in Subjects WithType 2 Diabetic Mellitus (T2DM) That is Inadequately Controlled by Metformin Monotherapy
1 other identifier
interventional
287
1 country
29
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Mar 2018
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2019
CompletedAugust 5, 2020
August 1, 2020
1.4 years
November 17, 2017
August 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change in the levels of glycosylated hemoglobin (HbA1c)
At baseline and at treatment week 16
Secondary Outcomes (6)
Responder rates
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
At baseline and at treatment week 16
- +1 more secondary outcomes
Study Arms (2)
Acarbose plus metformin arm
EXPERIMENTALParticipants received loose combination of acarbose and metformin 3 times daily.
Metformin plus placebo arm
ACTIVE COMPARATORParticipants received loose combination of placebo and metformin 3 times daily.
Interventions
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
500 mg 3 times daily, oral, with the first mouthful of main meal
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Fasting plasma glucose \> 14.0 mmol/L
- Severe metabolic diabetic complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (29)
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
Ürümqi, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2017
First Posted
November 21, 2017
Study Start
March 5, 2018
Primary Completion
August 12, 2019
Study Completion
August 21, 2019
Last Updated
August 5, 2020
Record last verified: 2020-08