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

September 24, 2013 updated by: EMS

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design:

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

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Jose Dos Campos, SP, Brazil, 12.245-000
        • Marcio Antonio Pereira Clinica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EMS Acarbose
Drug: EMS Acarbose
EMS Acarbose 50 mg 3 times a day
ACTIVE_COMPARATOR: Bayer Acarbose
Drug: Bayer Acarbose
Bayer Acarbose 50 mg 3 times a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in mean Fasting Plasma Glucose (FPG)
Time Frame: Change from baseline to day 14, 28, 42, 70 and 98
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
Day 105

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Investigators

  • Study Director: Felipe Pinho, MD, EMS S/A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (ESTIMATE)

March 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMSAGL0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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