Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus

A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus

The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2 Diabetic Patients Using Two Different Formulations of Acarbose 50mg.

Study Design:

• Multicenter
• Phase III
• Randomized
• Double Blind
• Prospective and Comparative
• Experiment duration: 105 days
• 5 visits
• Efficacy
• Adverse event

Inclusion Criteria:

• Patients must be able to understand the study procedures agree to participate and give written consent.
• Diagnosed with type 2 diabetes mellitus (t2dm)b
• Female patients of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) which agree to use a medically accepted contraceptive regimen for the duration of the study.

Exclusion Criteria:

• Pregnancy or risk of pregnancy.
• Lactation
• Any pathology or past medical condition that can interfere with this protocol
• Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
• Known hypersensitivity / intolerance to acarbose or any of its excipients