Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT03349684
- Lead Sponsor
- Bayer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
- 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
- Fasting plasma glucose > 14.0 mmol/L
- Severe metabolic diabetic complications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin plus placebo arm Placebo Participants received loose combination of placebo and metformin 3 times daily. Acarbose plus metformin arm Placebo Participants received loose combination of acarbose and metformin 3 times daily. Acarbose plus metformin arm Acarbose Participants received loose combination of acarbose and metformin 3 times daily. Metformin plus placebo arm Metformin Participants received loose combination of placebo and metformin 3 times daily. Acarbose plus metformin arm Metformin Participants received loose combination of acarbose and metformin 3 times daily.
- Primary Outcome Measures
Name Time Method Absolute change in the levels of glycosylated hemoglobin (HbA1c) At baseline and at treatment week 16
- Secondary Outcome Measures
Name Time Method Responder rates At week 16 Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) \< 7%, and 2) \< 6.5%
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 Insulin 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.
Number of participants with adverse events Up to 16 weeks
Trial Locations
- Locations (29)
The First Affiliated Hospital of Sun Yat-Sen University
π¨π³Guangzhou, Guangdong, China
Anhui Provincial Hospital
π¨π³Hefei, Anhui, China
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
π¨π³Guangzhou, Guangdong, China
The First Affiliated Hospital of Anhui Medical University
π¨π³Hefei, Anhui, China
The Second Affliated Hospital of Hainan Medical University
π¨π³Haikou, Hainan, China
Hainan Third People's Hospital (Province Nongken Sanya Hopt)
π¨π³Sanya, Hainan, China
1st Affiliated Hospital of Henan Science and Technology Univ
π¨π³Luoyang, Henan, China
The 3rd Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
Taihe Hospital
π¨π³Shiyan, Hubei, China
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
π¨π³Wuhan, Hubei, China
Chenzhou No. 1 People's Hospital
π¨π³Chenzhou, Hunan, China
1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
π¨π³Changzhou, Jiangsu, China
Huai'an First People's Hospital, Nanjing Medical University
π¨π³Huai'An, Jiangsu, China
Northern Jiangsu People's Hospital
π¨π³Yangzhou, Jiangsu, China
Jilin Province People's Hospital
π¨π³Changchun, Jilin, China
Affiliated Hospital of Jining Medical University
π¨π³Jining, Shandong, China
West China Hospital, Sichuan University
π¨π³Chengdu, Sichuan, China
Emergency General Hospital
π¨π³Beijing, China
Jiangxi PingXiang people's Hospital
π¨π³Pingxiang, China
Shanghai Tenth People's Hospital
π¨π³Shanghai, China
Beijing Pinggu Hospital
π¨π³Beijing, China
The first affiliated hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Jiangsu Province Hospital
π¨π³Nanjing, Jiangsu, China
Shandong Provincial Hospital
π¨π³Jinan, Shandong, China
1st Affiliated Hospital of Xi'an Jiaotong Medical University
π¨π³Xi'an, Shaanxi, China
Changsha Central Hospital
π¨π³Changsha, China
People's Hospital of Xinjiang Uygur Autonomous Region
π¨π³Urumqi, Xinjiang, China
Peking Union Medical College Hospital CAMS
π¨π³Beijing, China
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
π¨π³Tianjin, China