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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01316861
First received: March 15, 2011
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: EMS Acarbose
Drug: Bayer Acarbose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: Change from baseline to day 98 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in mean Fasting Plasma Glucose (FPG) [ Time Frame: Change from baseline to day 14, 28, 42, 70 and 98 ] [ Designated as safety issue: No ]
  • Safety will be evaluated by the Adverse events occurence [ Time Frame: Day 105 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability


Enrollment: 79
Study Start Date: September 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMS Acarbose Drug: EMS Acarbose
EMS Acarbose 50 mg 3 times a day
Active Comparator: Bayer Acarbose Drug: Bayer Acarbose
Bayer Acarbose 50 mg 3 times a day

Detailed Description:

Study Design:

  • Multicenter
  • Phase III
  • Randomized
  • Double Blind
  • Prospective and Comparative
  • Experiment duration: 105 days
  • 5 visits
  • Efficacy
  • Adverse event
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316861

Locations
Brazil
Marcio Antonio Pereira Clinica
Sao Jose Dos Campos, SP, Brazil, 12.245-000
Sponsors and Collaborators
EMS
Investigators
Study Director: Felipe Pinho, MD EMS S/A
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01316861     History of Changes
Other Study ID Numbers: EMSAGL0110
Study First Received: March 15, 2011
Last Updated: September 24, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Acarbose
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014