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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Shandong Provincial Hospital Jinan, China, 250021 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Affiliated Hospital of Anhui Medical University Hefei, China, 230022 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Anhui Provincial Hospital Hefei, China, 230001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Emergency General Hospital Beijing, China, 100028 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Huai'an First People's Hospital, Nanjing Medical University Huai'An, China, 223300 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ Changzhou, China, 213003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jiangsu Province Hospital Nanjing, China, 210029 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Beijing Pinggu Hospital Beijing, China, 101200 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hainan Third People's Hospital (Province Nongken Sanya Hopt) Sanya, China, 572000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Changsha Central Hospital Changsha, China, 410004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jiangxi PingXiang people's Hospital Pingxiang, China, 337055 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations People's Hospital of Xinjiang Uygur Autonomous Region Urumqi, China, 830001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Peking Union Medical College Hospital CAMS Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tianjin Union Medicine Centre (People's Hospital of Tianjin) Tianjin, China, 300121 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 1st Affiliated Hospital of Xi'an Jiaotong Medical University Xi'an, China, 710061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations West China Hospital, Sichuan University Chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The 3rd Affiliated Hospital of Guangzhou Medical University Guangzhou, China, 510150 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Affiliated Hospital of Sun Yat-Sen University guangzhou, China, 510080 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jilin Province People's Hospital Changchun, China, 130021 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Northern Jiangsu People's Hospital Yangzhou, China, 225001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chenzhou No. 1 People's Hospital Chenzhou, China, 423000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. Wuhan, China, 430030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV. Guangzhou, China, 510120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The first affiliated hospital of Zhengzhou University Zhengzhou, China, 450052 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Affiliated Hospital of Jining Medical University Jining, China, 272000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 1st Affiliated Hospital of Henan Science and Technology Univ Luoyang, China, 471000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Taihe Hospital Shiyan, China, 442008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Second Affliated Hospital of Hainan Medical University Haikou, China, 570311 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shanghai Tenth People's Hospital Shanghai, China, 200072 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Absolute change in the levels of glycosylated hemoglobin (HbA1c)Timeframe: At baseline and at treatment week 16
Secondary Outcome
- Responder ratesDefined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5%Timeframe: At week 16
- Change in 2-hour postprandial plasma glucose (PPG)Timeframe: At baseline and at treatment week 16
- Change in fasting plasma glucose (FPG) levelsTimeframe: At baseline and at treatment week 16
- Change in fasting serum insulin levelsTimeframe: At baseline and at treatment week 16
- Change in insulin resistance scoreInsulin 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.Timeframe: At baseline and at treatment week 16
- Number of participants with adverse eventsTimeframe: Up to 16 weeks
Additional Information
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