Efficacy and Safety of Oral Acarbose Treatment in Patient... | NCT01316861

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

NCT01316861

Sponsor

EMS

Status

Completed

Last Update Posted

Sep 25, 2013Estimated

Enrollment

79Actual

Phase

Phase 3

Conditions

Type 2 Diabetes Mellitus

Interventions

EMS Acarbose
Bayer Acarbose

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Mar 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Mar 15, 2011

First Submission Date that Met QC Criteria

Mar 15, 2011

First Posted Date

Mar 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2013

Last Update Posted Date

Sep 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EMS Acarbose	Experimental		Drug: EMS Acarbose
Bayer Acarbose	Active Comparator		Drug: Bayer Acarbose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMS Acarbose	Drug	EMS Acarbose 50 mg 3 times a day	EMS Acarbose
Bayer Acarbose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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	Adverse events will be collected and followed in order to evaluate safety and tolerability

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felipe Pinho, MD	EMS S/A	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marcio Antonio Pereira Clinica		São José dos Campos	São Paulo	12.245-000	Brazil

Type	Date	Date Unknown
Release	Feb 23, 2021
Reset	Mar 12, 2021
Release	Mar 30, 2021
Reset	Apr 23, 2021
Release	Jul 25, 2022
Reset	Jul 26, 2022

Submission Tracking

Estimated Results First Submitted Date

Feb 23, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 23, 2021			Mar 12, 2021
Mar 30, 2021

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided