HealthyPhase 1NTC00940472NCT01560481
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
A Phase 1 study testing Step A: metformin glycinate 620 mg single dose, Step A: metformin glycinate 1240 mg single dose and Step A: metformin glycinate 2480 mg single dose in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Spain.
Trial summary
Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Step A: metformin glycinate 620 mg single dose, Step A: metformin glycinate 1240 mg single dose and Step A: metformin glycinate 2480 mg single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2011to Mar 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years.
- Weight within normal ranges (Quetelet index between 21 and 26) (weight (kg)/height (m2).
- Adequate physical examination and clinical history
- No organic and psychiatric disorder
- Normal Blood pressure, Pulse Rate, temperature and ECG.
- Lab test within normal values according to reference lab values of Biochemistry lab of Hospital Santa Creu I Sant Pau. It will be allowed changes according to clinical criteria of the clinical staff of ICIM-SANT PAU
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- Females of childbearing potential with adequate contraceptive precautions, other than oral contraceptives and negative urine pregnancy test.
- No participation in any other clinical trial within the previous two months before the initiation of this study.
- No blood donation within the previous four weeks before the initiation of this study.
- Signed informed consent.
Who cannot join
- Drugs or alcohol abuse.
- Consumer of stimulant drinks (> 5 coffees, teas, cola drinks).
- Smokers (> 10 cigars).
- Precedents of drugs allergy or hypersensitivity
- Intake of any other medication within the previous 15 days before this study.
- Positive HIV, HBV or HCV.
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- Chronic disease (cardiovascular, respiratory, endocrine, gastrointestinal, hematologic, neurologic or others).
- Prior surgery within the previous six months before the initiation of this study.
- Pregnant women or breastfeeding or females of childbearing potential with no adequate contraceptive precautions, other than oral contraceptives.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
About this study
Official title: Randomized Clinical Trial to Evaluate Safety, Tolerability and PK-PD Profile of Metformin Glycinate 620 mg,1240 mg, 2480 mg and Metformin Chlorhydrate 1000 mg of One Single Dose, Multiple Dose and After Food Intake.
Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes.
The objective of this study is to evaluate the safety, tolerability and pK profile of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose, in step A. In step A will be included 25 volunteers.
In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be included 24 volunteers.
- Conditions
- Healthy
- Being tested
- Step A: metformin glycinate 620 mg single dose, Step A: metformin glycinate 1240 mg single dose, Step A: metformin glycinate 2480 mg single dose, Step A: metformin hydrochloride 1000 mg single dose, Step A: metformin glycinate 1240 mg,food intake
- Keywords
- metformin glycinate, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step A: metformin glycinate 620 mg single doseDrug
metformin glycinate 620 mg single dose
Step A: metformin glycinate 1240 mg single doseDrug
metformin glycinate 1240 mg single dose
Step A: metformin glycinate 2480 mg single doseDrug
metformin glycinate 2480 mg single dose
Step A: metformin hydrochloride 1000 mg single doseDrug
metformin Chlorhydrate 1000 mg single dose
Step A: metformin glycinate 1240 mg,food intakeDrug
metformin glycinate 1240 mg, intake of food
Step B: metformin glycinate 620 mg BIDDrug
metformin glycinate 620 mg BID, 8 days
Step B: metformin hydrochloride 500 mg BIDDrug
metformin Chlorhydrate 500 mg BID, 8 days
| Study group | Role | What they receive |
|---|---|---|
| Step A: metformin glycinate 620 mg | Experimental | 620mg single dose by mouth Receives: Drug: Step A: metformin glycinate 620 mg single dose |
| Step A: metformin glycinate 1240 mg | Experimental | 1240mg single dose by mouth Receives: Drug: Step A: metformin glycinate 1240 mg single dose |
| Step A: metformin glycinate 2480 mg | Experimental | 2480mg single dose by mouth Receives: Drug: Step A: metformin glycinate 2480 mg single dose |
| Step A: metformin hydrochloride 1000 mg | Active comparator | 1000mg single dose by mouth Receives: Drug: Step A: metformin hydrochloride 1000 mg single dose |
| Step A: metformin glycinate 1240 mg, food intake | Experimental | 1240mg single dose by mouth after food intake Receives: Drug: Step A: metformin glycinate 1240 mg,food intake |
| Step B: metformin glycinate 620 mg BID | Experimental | 620mg BID for 8 days Receives: Drug: Step B: metformin glycinate 620 mg BID |
| Step B: metformin hydrochloride 500 mg BID | Active comparator | 500mg tablets BID for 8 days Receives: Drug: Step B: metformin hydrochloride 500 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step A: Number of Adverse Events of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose
Tolerability:
- adverse events,
- systolic and diastolic blood pressure, pulse rate and temperature
- pulse rate and ECG alterations
- alterations in haematology, plasma chemistry, and urine analyses
Measured: 35 days
Step B: Number of Adverse Events of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days
Tolerability:
- adverse events,
- systolic and diastolic blood pressure, pulse rate and temperature
- pulse rate and ECG alterations
- alterations in haematology, plasma chemistry, and urine analyses
Measured: 25 days
Secondary outcomes (12)
Step A: Bioavailability (AUC) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD.
Measured: 36 hours
Step A: Linear and dose-proportional (AUC) pharmacokinetic of 620 mg, 1240 mg and 2480 strengths of metformin glycinate
Measured: 36 hours
Step A: Bioavailability (AUC) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast
Measured: 36 hours
Step A: Pharmacokinetic profile (AUC) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD.
Measured: 36 hours
Step B: Bioavailability (AUC) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days.
Measured: 8 days
Step B: Pharmacokinetic profile (AUC) of metformin glycinate 620mg BID after administration of multiple doses during 8 days
Measured: 8 days
Step A: Bioavailability (Cmax) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD.
Measured: 36 hours
Step A: Linear and dose-proportional pharmacokinetic (Cmax) of 620 mg, 1240 mg and 2480 strengths of metformin glycinate
Measured: 36 hours
Step A: Bioavailability (Cmax) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast
Measured: 36 hours
Step A: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD.
Measured: 36 hours
Step B: Bioavailability (Cmax) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days.
Measured: 8 days
Step B: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg BID after administration of multiple doses during 8 days
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2013
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosa M Antonijoan, MD, Study chair, Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560481
- Sponsor's protocol ID
- NTC00940472
- Acronym
- NTC00940472
- Status last verified
- Jan 2018
- First submitted
- 9 Feb 2012
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
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
- Randomized Clinical Trial to Evaluate Safety, Tolerability and PK-PD Profile of Metformin Glycinate 620 mg,1240 mg, 2480 mg and Metformin Chlorhydrate 1000 mg of One Single Dose, Multiple Dose and After Food Intake.
- ClinicalTrials.gov ID
- NCT01560481
- Acronym / sponsor ID
- NTC00940472 / NTC00940472
- Conditions
- Healthy
- Keywords
- metformin glycinate, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Mar 2012 (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.
Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes.
The objective of this study is to evaluate the safety, tolerability and pK profile of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose, in step A. In step A will be included 25 volunteers.
In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be included 24 volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Step A: metformin glycinate 620 mg | Experimental | Drug: Step A: metformin glycinate 620 mg single dose620mg single dose by mouth |
| Step A: metformin glycinate 1240 mg | Experimental | Drug: Step A: metformin glycinate 1240 mg single dose1240mg single dose by mouth |
| Step A: metformin glycinate 2480 mg | Experimental | Drug: Step A: metformin glycinate 2480 mg single dose2480mg single dose by mouth |
| Step A: metformin hydrochloride 1000 mg | Active comparator | Drug: Step A: metformin hydrochloride 1000 mg single dose1000mg single dose by mouth |
| Step A: metformin glycinate 1240 mg, food intake | Experimental | Drug: Step A: metformin glycinate 1240 mg,food intake1240mg single dose by mouth after food intake |
| Step B: metformin glycinate 620 mg BID | Experimental | Drug: Step B: metformin glycinate 620 mg BID620mg BID for 8 days |
| Step B: metformin hydrochloride 500 mg BID | Active comparator | Drug: Step B: metformin hydrochloride 500 mg BID500mg tablets BID for 8 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age between 18 and 45 years.
- Weight within normal ranges (Quetelet index between 21 and 26) (weight (kg)/height (m2).
- Adequate physical examination and clinical history
- No organic and psychiatric disorder
- Normal Blood pressure, Pulse Rate, temperature and ECG.
Key exclusion criteria (9 listed)
- Drugs or alcohol abuse.
- Consumer of stimulant drinks (> 5 coffees, teas, cola drinks).
- Smokers (> 10 cigars).
- Precedents of drugs allergy or hypersensitivity
- Intake of any other medication within the previous 15 days before this study.
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 |
|---|---|---|
| Step A: metformin glycinate 620 mg single dosemetformin glycinate 620 mg single dose | Drug | Step A: metformin glycinate 620 mg |
| Step A: metformin glycinate 1240 mg single dosemetformin glycinate 1240 mg single dose | Drug | Step A: metformin glycinate 1240 mg |
| Step A: metformin glycinate 2480 mg single dosemetformin glycinate 2480 mg single dose | Drug | Step A: metformin glycinate 2480 mg |
| Step A: metformin hydrochloride 1000 mg single dosemetformin Chlorhydrate 1000 mg single dose | Drug | Step A: metformin hydrochloride 1000 mg |
| Step A: metformin glycinate 1240 mg,food intakemetformin glycinate 1240 mg, intake of food | Drug | Step A: metformin glycinate 1240 mg, food intake |
| Step B: metformin glycinate 620 mg BIDmetformin glycinate 620 mg BID, 8 days | Drug | Step B: metformin glycinate 620 mg BID |
| Step B: metformin hydrochloride 500 mg BIDmetformin Chlorhydrate 500 mg BID, 8 days | Drug | Step B: metformin hydrochloride 500 mg BID |
Primary outcome
Step A: Number of Adverse Events of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose
Time frame: 35 days
Tolerability: * adverse events, * systolic and diastolic blood pressure, pulse rate and temperature * pulse rate and ECG alterations * alterations in haematology, plasma chemistry, and urine analyses
Step B: Number of Adverse Events of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days
Time frame: 25 days
Tolerability: * adverse events, * systolic and diastolic blood pressure, pulse rate and temperature * pulse rate and ECG alterations * alterations in haematology, plasma chemistry, and urine analyses
12 secondary outcomes
Step A: Bioavailability (AUC) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD.
Time frame: 36 hours
Step A: Linear and dose-proportional (AUC) pharmacokinetic of 620 mg, 1240 mg and 2480 strengths of metformin glycinate
Time frame: 36 hours
Step A: Bioavailability (AUC) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast
Time frame: 36 hours
Step A: Pharmacokinetic profile (AUC) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD.
Time frame: 36 hours
Step B: Bioavailability (AUC) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days.
Time frame: 8 days
Step B: Pharmacokinetic profile (AUC) of metformin glycinate 620mg BID after administration of multiple doses during 8 days
Time frame: 8 days
Step A: Bioavailability (Cmax) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD.
Time frame: 36 hours
Step A: Linear and dose-proportional pharmacokinetic (Cmax) of 620 mg, 1240 mg and 2480 strengths of metformin glycinate
Time frame: 36 hours
Step A: Bioavailability (Cmax) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast
Time frame: 36 hours
Step A: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD.
Time frame: 36 hours
Step B: Bioavailability (Cmax) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days.
Time frame: 8 days
Step B: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg BID after administration of multiple doses during 8 days
Time frame: 8 days
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.
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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.
Rosa M Antonijoan, MD study chair
Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau
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 Step A: metformin glycinate 620 mg single dose, Step A: metformin glycinate 1240 mg single dose and Step A: metformin glycinate 2480 mg single dose in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Spain.
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 10 inclusion and 9 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 Spain. 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?
Step A: Number of Adverse Events of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose (time frame: 35 days). The study lists 2 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 30 Jan 2018.