Clinical trial NCT03349684: Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-11-21
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Absolute change in the levels of glycosylated hemoglobin (HbA1c)
timeFrame: At baseline and at treatment week 16
Secondary outcomes:
measure: Responder rates
timeFrame: At week 16
measure: Change in 2-hour postprandial plasma glucose (PPG)
timeFrame: At baseline and at treatment week 16
measure: Change in fasting plasma glucose (FPG) levels
timeFrame: At baseline and at treatment week 16
measure: Change in fasting serum insulin levels
timeFrame: At baseline and at treatment week 16
measure: Change in insulin resistance score
timeFrame: At baseline and at treatment week 16
measure: Number of participants with adverse events
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
state: Guangdong
city: Guangzhou
country: China
facility: The 3rd Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Haikou
country: China
facility: The Second Affliated Hospital of Hainan Medical University
state: Hainan
city: Sanya
country: China
facility: Hainan Third People's Hospital (Province Nongken Sanya Hopt)
state: Hainan
city: Luoyang
country: China
facility: 1st Affiliated Hospital of Henan Science and Technology Univ
state: Henan
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
state: Hubei
city: Chenzhou
country: China
facility: Chenzhou No. 1 People's Hospital
state: Hunan
city: Changzhou
country: China
facility: 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
state: Jiangsu
city: Huai'An
country: China
facility: Huai'an First People's Hospital, Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Xi'an
country: China
facility: 1st Affiliated Hospital of Xi'an Jiaotong Medical University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Beijing
country: China
facility: Emergency General Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital CAMS
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Changsha
country: China
facility: Changsha Central Hospital
city: Pingxiang
country: China
facility: Jiangxi PingXiang people's Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Tianjin
country: China
facility: Tianjin Union Medicine Centre (People's Hospital of Tianjin)
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: