HealthyPhase 1NCT00960882
Gastric Tolerability and Pharmacokinetics of DMMET-01
A Phase 1 study testing DMMET-01 in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial summary
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DMMET-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2007to Apr 2008
- Phase
- Phase 1
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)
Who cannot join
- Familiar or personal history of diabetes
- History of drug or alcohol abuse within the 2 years prior to the study
- A smoking habit greater tha 10 cigarettes per day
- Intercurrent disease
- Intercurrent treatment with any drug
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Pharmacology and toxicology department, UANL
Monterrey, Nuevo León, 64460
About this study
Official title: Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.
- Conditions
- Healthy
- Being tested
- DMMET-01
- Keywords
- Pharmacokinetics, Diabetes, gastric tolerability
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMMET-01Drug
1050.6 mg daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| DMMET-01 | Experimental | Not described Receives: Drug: DMMET-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DMMET-01 Plasmatic concentration
Measured: 48 hrs (7.5; 15; 30; 45; 60; 75; 90; 120; 150; 180; 205; 240; 360; 480; 600; 720; 1440 and 2880 min)
Secondary outcomes (3)
Lanza score
Measured: 30 days (0 and 30)
plasmatic glucose
Measured: 24 hours (6,12,18 and 24)
glycated hemoglobin
Measured: 24 hours (0 and 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJun 2007
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar Torres, PhD, Principal investigator, UANL, Pharmacology and toxicology departmentJorge A Gonzalez, Master, Study director, Laboratorios Silanes S.A. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960882
- Sponsor's protocol ID
- DMMET 1011/07
- Status last verified
- Jan 2018
- First submitted
- 14 Aug 2009
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00960882
- Acronym / sponsor ID
- DMMET 1011/07
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Diabetes, gastric tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Aug 2009 (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 determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMMET-01 | Experimental | Drug: DMMET-01 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)
Key exclusion criteria (5 listed)
- Familiar or personal history of diabetes
- History of drug or alcohol abuse within the 2 years prior to the study
- A smoking habit greater tha 10 cigarettes per day
- Intercurrent disease
- Intercurrent treatment with any drug
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 |
|---|---|---|
| DMMET-011050.6 mg daily for 30 days | Drug | DMMET-01 |
Primary outcome
DMMET-01 Plasmatic concentration
Time frame: 48 hrs (7.5; 15; 30; 45; 60; 75; 90; 120; 150; 180; 205; 240; 360; 480; 600; 720; 1440 and 2880 min)
3 secondary outcomes
Lanza score
Time frame: 30 days (0 and 30)
plasmatic glucose
Time frame: 24 hours (6,12,18 and 24)
glycated hemoglobin
Time frame: 24 hours (0 and 24)
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 30 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Oscar Torres, PhD principal investigator
UANL, Pharmacology and toxicology department
Jorge A Gonzalez, Master 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 1 study testing DMMET-01 in people with Healthy, 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 1 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 30 Jan 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
DMMET-01 Plasmatic concentration (time frame: 48 hrs (7.5; 15; 30; 45; 60; 75; 90; 120; 150; 180; 205; 240; 360; 480; 600; 720; 1440 and 2880 min)). 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 30 Jan 2018.