Endothelial DysfunctionPhase 4NCT01429818
Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients
A Phase 4 study testing Glimepiride/metformin and Metformin in people with Endothelial Dysfunction and Diabetes Mellitus, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial summary
The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction, Diabetes Mellitus
- What is being tested?
- Glimepiride/metformin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2007to Jan 2008
- Phase
- Phase 4
- 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
- Both genders
- At least 18 years old
- Type 2 diabetes mellitus diagnosis
- Signed Informed Consent
Who cannot join
- History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases
- Pregnancy or lactation
- History of abuse and/or substance dependence within 6 months preceding the survey.
- History of glimepiride or metformin allergy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México
Mexico City, Mexico City, 04510
About this study
Official title: Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)
The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).
- Conditions
- Endothelial Dysfunction, Diabetes Mellitus
- Being tested
- Glimepiride/metformin, Metformin
- Keywords
- Endothelial dysfunction, Diabetes mellitus, glimepiride, metformin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glimepiride/metforminDrug
Also called GLIMETAL
4/1000 mg tablets once a day foe eight weeks
MetforminDrug
Also called PREDIAL
1000 mg tablets once daily for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Glimepiride/metformin | Experimental | Not described Receives: Drug: Glimepiride/metformin |
| Metformin | Active comparator | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDVI
endothelial-dependent vasodilation index
Measured: 8 weeks
MFR
myocardial flow reserve
Measured: 8 weeks
%ΔMBF
percentage of the change between rest and CPT
Measured: 8 weeks
Secondary outcomes (3)
Fasting glucose
Measured: 8 weeks
Glycated hemoglobin
Measured: 8 weeks
Adverse effects
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge González, MD, Study director, Laboratorios Silanes S.A. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429818
- Sponsor's protocol ID
- PET-GLI01
- Status last verified
- Sep 2011
- First submitted
- 5 Sep 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)
- ClinicalTrials.gov ID
- NCT01429818
- Acronym / sponsor ID
- PET-GLI01
- Conditions
- Endothelial Dysfunction, Diabetes Mellitus
- Keywords
- Endothelial dysfunction, Diabetes mellitus, glimepiride, metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Sep 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 was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glimepiride/metformin | Experimental | Drug: Glimepiride/metformin |
| Metformin | Active comparator | Drug: Metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders
- At least 18 years old
- Type 2 diabetes mellitus diagnosis
- Signed Informed Consent
Key exclusion criteria (4 listed)
- History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases
- Pregnancy or lactation
- History of abuse and/or substance dependence within 6 months preceding the survey.
- History of glimepiride or metformin allergy
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 |
|---|---|---|
| Glimepiride/metforminAlso: GLIMETAL4/1000 mg tablets once a day foe eight weeks | Drug | Glimepiride/metformin |
| MetforminAlso: PREDIAL1000 mg tablets once daily for eight weeks | Drug | Metformin |
Primary outcome
EDVI
Time frame: 8 weeks
endothelial-dependent vasodilation index
MFR
Time frame: 8 weeks
myocardial flow reserve
%ΔMBF
Time frame: 8 weeks
percentage of the change between rest and CPT
3 secondary outcomes
Fasting glucose
Time frame: 8 weeks
Glycated hemoglobin
Time frame: 8 weeks
Adverse effects
Time frame: 8 weeks
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 7 Sep 2011.
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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.
Jorge González, MD study director
Laboratorios Silanes S.A. de C.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glimepiride/metformin and Metformin in people with Endothelial Dysfunction and Diabetes Mellitus, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
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 4 inclusion and 4 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 7 Sep 2011. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
EDVI (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 7 Sep 2011.