Status:
COMPLETED
Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
Lead Sponsor:
Bayer
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
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 m...
Eligibility Criteria
Inclusion
- 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
- Fasting plasma glucose \> 14.0 mmol/L
- Severe metabolic diabetic complications
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2019
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT03349684
Start Date
March 5 2018
End Date
August 21 2019
Last Update
August 5 2020
Active Locations (29)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
3
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
4
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, China, 510120