Diabetes Mellitus, Type 2 Clinical Trial
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
| NCT number | NCT03349684 |
| Other study ID # | 17886 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | March 5, 2018 |
| Est. completion date | August 21, 2019 |
| Verified date | August 2020 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 287 |
| Est. completion date | August 21, 2019 |
| Est. primary completion date | August 12, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 79 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Pinggu Hospital | Beijing | |
| China | Emergency General Hospital | Beijing | |
| China | Peking Union Medical College Hospital CAMS | Beijing | |
| China | Jilin Province People's Hospital | Changchun | Jilin |
| China | Changsha Central Hospital | Changsha | |
| China | 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ | Changzhou | Jiangsu |
| China | West China Hospital, Sichuan University | Chengdu | Sichuan |
| China | Chenzhou No. 1 People's Hospital | Chenzhou | Hunan |
| China | Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ. | Guangzhou | Guangdong |
| China | The 3rd Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong |
| China | The Second Affliated Hospital of Hainan Medical University | Haikou | Hainan |
| China | Anhui Provincial Hospital | Hefei | Anhui |
| China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
| China | Huai'an First People's Hospital, Nanjing Medical University | Huai'An | Jiangsu |
| China | Shandong Provincial Hospital | Jinan | Shandong |
| China | Affiliated Hospital of Jining Medical University | Jining | Shandong |
| China | 1st Affiliated Hospital of Henan Science and Technology Univ | Luoyang | Henan |
| China | Jiangsu Province Hospital | Nanjing | Jiangsu |
| China | Jiangxi PingXiang people's Hospital | Pingxiang | |
| China | Hainan Third People's Hospital (Province Nongken Sanya Hopt) | Sanya | Hainan |
| China | Shanghai Tenth People's Hospital | Shanghai | |
| China | Taihe Hospital | Shiyan | Hubei |
| China | Tianjin Union Medicine Centre (People's Hospital of Tianjin) | Tianjin | |
| China | People's Hospital of Xinjiang Uygur Autonomous Region | Urumqi | Xinjiang |
| China | Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. | Wuhan | Hubei |
| China | 1st Affiliated Hospital of Xi'an Jiaotong Medical University | Xi'an | Shaanxi |
| China | Northern Jiangsu People's Hospital | Yangzhou | Jiangsu |
| China | The first affiliated hospital of Zhengzhou University | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Absolute change in the levels of glycosylated hemoglobin (HbA1c) | At baseline and at treatment week 16 | ||
| Secondary | Responder rates | Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5% | At week 16 | |
| Secondary | Change in 2-hour postprandial plasma glucose (PPG) | At baseline and at treatment week 16 | ||
| Secondary | Change in fasting plasma glucose (FPG) levels | At baseline and at treatment week 16 | ||
| Secondary | Change in fasting serum insulin levels | At baseline and at treatment week 16 | ||
| Secondary | Change in insulin resistance score | 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. | At baseline and at treatment week 16 | |
| Secondary | Number of participants with adverse events | Up to 16 weeks |
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