Type 2 Diabetes MellitusPhase 3NCT01316861
Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing EMS Acarbose and Bayer Acarbose in people with Type 2 Diabetes Mellitus, run by EMS at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- EMS Acarbose and Bayer Acarbose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Marcio Antonio Pereira Clinica
São José dos Campos, São Paulo, 12.245-000
About this study
Official title: 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.
Read the detailed description
Study Design:
- Multicenter
- Phase III
- Randomized
- Double Blind
- Prospective and Comparative
- Experiment duration: 105 days
- 5 visits
- Efficacy
- Adverse event
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- EMS Acarbose, Bayer Acarbose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMS AcarboseDrug
EMS Acarbose 50 mg 3 times a day
Bayer AcarboseDrug
Bayer Acarbose 50 mg 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| EMS Acarbose | Experimental | Not described Receives: Drug: EMS Acarbose |
| Bayer Acarbose | Active comparator | Not described Receives: Drug: Bayer Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin (HbA1c)
Measured: Change from baseline to day 98
Secondary outcomes (2)
Decrease in mean Fasting Plasma Glucose (FPG)
Measured: Change from baseline to day 14, 28, 42, 70 and 98
Safety will be evaluated by the Adverse events occurence
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felipe Pinho, MD, Study director, EMS S/A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316861
- Sponsor's protocol ID
- EMSAGL0110
- Status last verified
- Sep 2013
- First submitted
- 15 Mar 2011
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01316861
- Acronym / sponsor ID
- EMSAGL0110
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
- Multicenter
- Phase III
- Randomized
- Double Blind
- Prospective and Comparative
- Experiment duration: 105 days
- 5 visits
- Efficacy
- Adverse event
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMS Acarbose | Experimental | Drug: EMS Acarbose |
| Bayer Acarbose | Active comparator | Drug: Bayer Acarbose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMS AcarboseEMS Acarbose 50 mg 3 times a day | Drug | EMS Acarbose |
| Bayer AcarboseBayer Acarbose 50 mg 3 times a day | Drug | Bayer Acarbose |
Primary outcome
Glycosylated hemoglobin (HbA1c)
Time frame: Change from baseline to day 98
2 secondary outcomes
Decrease in mean Fasting Plasma Glucose (FPG)
Time frame: Change from baseline to day 14, 28, 42, 70 and 98
Safety will be evaluated by the Adverse events occurence
Time frame: Day 105
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Pinho, MD study director
EMS S/A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EMS Acarbose and Bayer Acarbose in people with Type 2 Diabetes Mellitus, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (HbA1c) (time frame: Change from baseline to day 98). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2013.