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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
EMS Acarbose
Bayer Acarbose
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Marcio Antonio Pereira Clinica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EMS Acarbose

Bayer Acarbose

Arm Description

Outcomes

Primary Outcome Measures

Glycosylated hemoglobin (HbA1c)

Secondary Outcome Measures

Decrease in mean Fasting Plasma Glucose (FPG)
Safety will be evaluated by the Adverse events occurence
Adverse events will be collected and followed in order to evaluate safety and tolerability

Full Information

First Posted
March 15, 2011
Last Updated
September 24, 2013
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT01316861
Brief Title
Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
Official Title
A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMS Acarbose
Arm Type
Experimental
Arm Title
Bayer Acarbose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
EMS Acarbose
Intervention Description
EMS Acarbose 50 mg 3 times a day
Intervention Type
Drug
Intervention Name(s)
Bayer Acarbose
Intervention Description
Bayer Acarbose 50 mg 3 times a day
Primary Outcome Measure Information:
Title
Glycosylated hemoglobin (HbA1c)
Time Frame
Change from baseline to day 98
Secondary Outcome Measure Information:
Title
Decrease in mean Fasting Plasma Glucose (FPG)
Time Frame
Change from baseline to day 14, 28, 42, 70 and 98
Title
Safety will be evaluated by the Adverse events occurence
Description
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame
Day 105

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Pinho, MD
Organizational Affiliation
EMS S/A
Official's Role
Study Director
Facility Information:
Facility Name
Marcio Antonio Pereira Clinica
City
Sao Jose Dos Campos
State/Province
SP
ZIP/Postal Code
12.245-000
Country
Brazil

12. IPD Sharing Statement

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

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