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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

March 15, 2011
September 24, 2013
September 2012
March 2013   (final data collection date for primary outcome measure)
Glycosylated hemoglobin (HbA1c) [ Time Frame: Change from baseline to day 98 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01316861 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus

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.

Study Design:

  • Multicenter
  • Phase III
  • Randomized
  • Double Blind
  • Prospective and Comparative
  • Experiment duration: 105 days
  • 5 visits
  • Efficacy
  • Adverse event
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: EMS Acarbose
    EMS Acarbose 50 mg 3 times a day
  • Drug: Bayer Acarbose
    Bayer Acarbose 50 mg 3 times a day
  • Experimental: EMS Acarbose
    Intervention: Drug: EMS Acarbose
  • Active Comparator: Bayer Acarbose
    Intervention: Drug: Bayer Acarbose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
May 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01316861
EMSAGL0110
Yes
EMS
EMS
Not Provided
Study Director: Felipe Pinho, MD EMS S/A
EMS
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP