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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316861
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : September 25, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: EMS Acarbose Drug: Bayer Acarbose Phase 3

Detailed Description:

Study Design:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Glycosylated hemoglobin (HbA1c) [ Time Frame: Change from baseline to day 98 ]

Secondary Outcome Measures :
  1. Decrease in mean Fasting Plasma Glucose (FPG) [ Time Frame: Change from baseline to day 14, 28, 42, 70 and 98 ]
  2. Safety will be evaluated by the Adverse events occurence [ Time Frame: Day 105 ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01316861

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

Responsible Party: EMS Identifier: NCT01316861     History of Changes
Other Study ID Numbers: EMSAGL0110
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013

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