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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316861
• Other study ID #: EMSAGL0110
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2011
• Last updated: September 24, 2013
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Study Design:

• Multicenter

• Phase III

• Randomized

• Double Blind

• Prospective and Comparative

• Experiment duration: 105 days

• 5 visits

• Efficacy

• Adverse event

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• EMS Acarbose
EMS Acarbose 50 mg 3 times a day
• Bayer Acarbose
Bayer Acarbose 50 mg 3 times a day

Locations

Country	Name	City	State
Brazil	Marcio Antonio Pereira Clinica	Sao Jose Dos Campos	SP

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin (HbA1c)		Change from baseline to day 98	No
Secondary	Decrease in mean Fasting Plasma Glucose (FPG)		Change from baseline to day 14, 28, 42, 70 and 98	No
Secondary	Safety will be evaluated by the Adverse events occurence	Adverse events will be collected and followed in order to evaluate safety and tolerability	Day 105	Yes