Efficacy and Safety of Voglibose Compared With Acarbose in Participants With Type 2 Diabetes

Inclusion Criteria

• Has a historical diagnosis of type 2 diabetes mellitus (T2DM) for at least 6 months prior to the screening visit (V1).
• Is male or female and aged from 18 to 75 years, inclusively.
• Has a body mass index (BMI) between 20 and 45 kg/m^2, inclusively.
• Is experiencing inadequate glycemic control with a glycosylated hemoglobin (HbA1c) concentration between 7.0% and 10.0%, inclusively.
• Has been treated with Metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to Screening, unless there is documentation that the participant's current dose is his or her maximum tolerated dose (MTD) and MTD is ≤1000 mg/day.
• Keeps constant body weight with fluctuation range no more than 10% over for at least 3 months before screening.
• Hemoglobin levels of the participant are ≥12 g/dL (≥120 g/L) in male and≥ 10 g/dL (≥100 g/L) in female at screening visit.
• Male serum creatinine 60 ml/min/1.73m^2 based on calculation using the Modification of Diet in Renal Disease (MDRD) approximation at Screening.
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria

• Type 1 diabetes mellitus.
• Has received insulin, voglibose, acarbose or other oral hypoglycemic drugs (except Metformin) for accumulative total of more than 7 days within the latest 3 months prior to Visit 1.
• Has a history of cardiovascular disease: acute myocardial infarction, class III or IV heart failure, or cerebrovascular accident (stroke) within the latest 3 months prior to Visit 1.
• The participant's liver function is damaged and has a significant clinical sign or symptom of hepatopathy, acute or chronic hepatitis, or the value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 3 times more than the upper limit of normal level at Visit 1.
• Has an active proliferative retinopathy or macular degeneration that need to have an urgent treatment in the opinion of investigators.
• Has a frequent attack of hypoglycemia or loses consciousness due to hypoglycemia in the opinion of investigators.
• Has one or more times ketoacidosis or hyperosmotic status/coma.
• Is receiving long-term (>14days) systemic glucocorticoid treatment (except the medicine: local, intraocular, inhalation or via the nose) or has received such treatment for 4 weeks at Visit 1.
• Has a hematopathy (e.g. hemolytic anemia, drepanocytosis) that may interfere with the HbA1c test.
• Has other liabilities (e.g. drug abuse, alcoholism or mental disorder) that may hinder the participant to follow and complete the study.
• Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
• Is unsuitable for this study in the opinion of investigators.
• Has a disease need to use other taboo or caution drugs that is not listed in this study.
• If female, is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study.