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

NCT ID: NCT01316861

Last Updated: 2013-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Study Design:

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

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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EMS Acarbose

Group Type EXPERIMENTAL

EMS Acarbose

Intervention Type DRUG

EMS Acarbose 50 mg 3 times a day

Bayer Acarbose

Group Type ACTIVE_COMPARATOR

Bayer Acarbose

Intervention Type DRUG

Bayer Acarbose 50 mg 3 times a day

Interventions

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EMS Acarbose

EMS Acarbose 50 mg 3 times a day

Intervention Type DRUG

Bayer Acarbose

Bayer Acarbose 50 mg 3 times a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Felipe Pinho, MD

Role: STUDY_DIRECTOR

EMS S/A

Locations

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Marcio Antonio Pereira Clinica

São José dos Campos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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EMSAGL0110

Identifier Type: -

Identifier Source: org_study_id