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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2013

Detailed Description

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

Interventions

  • Drug: EMS Acarbose
    • EMS Acarbose 50 mg 3 times a day
  • Drug: Bayer Acarbose
    • Bayer Acarbose 50 mg 3 times a day

Arms, Groups and Cohorts

  • Experimental: EMS Acarbose
  • Active Comparator: Bayer Acarbose

Clinical Trial Outcome Measures

Primary Measures

  • Glycosylated hemoglobin (HbA1c)
    • Time Frame: Change from baseline to day 98

Secondary Measures

  • Decrease in mean Fasting Plasma Glucose (FPG)
    • Time Frame: Change from baseline to day 14, 28, 42, 70 and 98
  • Safety will be evaluated by the Adverse events occurence
    • Time Frame: Day 105
    • Adverse events will be collected and followed in order to evaluate safety and tolerability

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMS
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Felipe Pinho, MD, Study Director, EMS S/A

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