Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients

• Status: Completed
• Trial end date: 2019-08-21
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Acarbose; Metformin

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