NCT03349684

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Acarbose	Uptitrated in the treatment phase from 50 mg per day for 1 week, followed by 100 mg per day for another week, and 150 mg per day for the rest 14 weeks, oral, with the first mouthful of main meal
DRUG	Metformin	500 mg 3 times daily, oral, with the first mouthful of main meal
DRUG	Placebo	Acarbose matching placebo, oral

Timeline

• Start date: 2018-03-05
• Primary completion: 2019-08-12
• Completion: 2019-08-21
• First posted: 2017-11-21
• Last updated: 2020-08-05

Locations

29 sites across 1 country: China