Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Open-label, Non-inferiority Study to Compare the Efficacy and Safety of Voglibose and Acarbose in Patients With Type 2 Diabetes Mellitus With Poor Control of Metformin
The primary purpose of this study is to evaluate the efficacy of voglibose versus acarbose combined with metformin in participants with type 2 diabetes mellitus (T2DM) by evaluating levels of glycosylated hemoglobin.
The drug being tested in this study is called voglibose. Voglibose is being tested to treat
type 2 diabetes in people who have diabetes that is inadequately controlled on metformin
alone. This study will look at glycemic control in people who take voglibose.
The study will enroll 494 patients. All participants will be enrolled in a 2-week screening
phase and a metformin run-in phase. Eligible participants will be randomly assigned (by
chance, like flipping a coin) to one of the two treatment groups:
- Metformin and Voglibose 0.2 mg
- Metformin and Acarbose 50 mg
All participants will be asked to take their current dose of metformin tablets and either
voglibose or acarbose tablets three times a day throughout the study.
This multi-center trial will be conducted in China. The overall time to participate in this
study is up to 20 weeks and participants will make 8 visits to the clinic.
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