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

EMS

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: EMS Acarbose; Drug: Bayer Acarbose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01316861

EMSAGL0110

Details and patient eligibility

About

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.

Full description

Study Design:

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

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups

EMS Acarbose

Experimental group

Treatment:

Drug: EMS Acarbose

Bayer Acarbose

Active Comparator group

Treatment:

Drug: Bayer Acarbose