- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01316861
Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
September 24, 2013 updated by: EMS
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
79
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Sao Jose Dos Campos, SP, Brazil, 12.245-000
- Marcio Antonio Pereira Clinica
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: EMS Acarbose
|
EMS Acarbose 50 mg 3 times a day
|
ACTIVE_COMPARATOR: Bayer Acarbose
|
Bayer Acarbose 50 mg 3 times a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycosylated hemoglobin (HbA1c)
Time Frame: Change from baseline to day 98
|
Change from baseline to day 98
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in mean Fasting Plasma Glucose (FPG)
Time Frame: Change from baseline to day 14, 28, 42, 70 and 98
|
Change from baseline to day 14, 28, 42, 70 and 98
|
|
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
|
Day 105
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Felipe Pinho, MD, EMS S/A
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
March 15, 2011
First Submitted That Met QC Criteria
March 15, 2011
First Posted (ESTIMATE)
March 16, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
September 25, 2013
Last Update Submitted That Met QC Criteria
September 24, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMSAGL0110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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