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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: EMS Acarbose; Drug: Bayer Acarbose

• Registration Number: NCT01316861
• Lead Sponsor: EMS

Brief Summary

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

Study Design:

* Multicenter

* Phase III

* Randomized

* Double Blind

* Prospective and Comparative

* Experiment duration: 105 days

* 5 visits

* Efficacy

* Adverse event

Study Timeline

• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-16
• Study Start: 2012-09
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMS Acarbose	EMS Acarbose	-
Bayer Acarbose	Bayer Acarbose	-

Primary Outcome Measures

Name	Time	Method
Glycosylated hemoglobin (HbA1c)	Change from baseline to day 98

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Marcio Antonio Pereira Clinica; 🇧🇷 Sao Jose Dos Campos, SP, Brazil