NCT01316861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 25, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

March 15, 2011

Last Update Submit

September 24, 2013

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Glycosylated hemoglobin (HbA1c)

    Change from baseline to day 98

Secondary Outcomes (2)

  • Decrease in mean Fasting Plasma Glucose (FPG)

    Change from baseline to day 14, 28, 42, 70 and 98

  • Safety will be evaluated by the Adverse events occurence

    Day 105

Study Arms (2)

EMS Acarbose

EXPERIMENTAL
Drug: EMS Acarbose

Bayer Acarbose

ACTIVE COMPARATOR
Drug: Bayer Acarbose

Interventions

EMS AcarboseDRUG

EMS Acarbose 50 mg 3 times a day

EMS Acarbose
Bayer AcarboseDRUG

Bayer Acarbose 50 mg 3 times a day

Bayer Acarbose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcio Antonio Pereira Clinica

São José dos Campos, São Paulo, 12.245-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Felipe Pinho, MD

    EMS S/A

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 16, 2011

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

September 25, 2013

Record last verified: 2013-09

Locations

BR(1)