Type II DiabetesPhase 2PAZ320NCT04569214
The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients
A Phase 2 study testing PAZ320 in people with Type II Diabetes, run by Boston Therapeutics at 1 site in France.
Trial summary
The purpose of this study is to test the efficacy of PAZ320 in diabetic patients. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- PAZ320
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Feb 2013
- Phase
- Phase 2
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type II diabetes since at least one year, not presenting any complications of their disease.
- Patients under treatment with Metformin up to 3g/day, given twice or three times daily. Metformin doses should not exceed 3g/day, and should be well tolerated by the patients, its dose should have been stable for the last 3 months before inclusion in the study. Metformin should be taken in the morning of the visit only after the test meal is taken. The next doses of metformin will be taken with meals after the visit, in the habitual order the patient is used to take. The patients should not stop taking metformin during the study, but continue as usual, except that in the mornings of the visits, as the patients arrive in fasting conditions, metformin should be taken after the test meal. If a concomitant combination with an oral anti diabetic agent is given, because of elevated HbA1c levels, it should be taken together with metformin after the test meal.
- Age - between 35 and 65, male and female.
- Females should not be pregnant or breast feeding, women of child bearing potential should guarantee anti-contraceptive measures.
- BMI (body mass index) - between 25 and 32.
- Patients with glycated hemoglobin (HbA1c) lower than 9%, and higher than 6.5%, HbA1c will be determined in the first visit.
- Patients who are able to collaborate during the entire duration of the study.
Who cannot join
- Patients with other underlying diseases, such as cardiovascular disease, renal disease, peripheral vascular disease or any condition considered to be a complication of diabetes, should be excluded from this study.
- Patients treated with insulin subcutaneous injections or with GLP-1 agonists, or by alpha-glucosidase inhibitors or by glinides should not be included in the study.
- HbA1c higher than 9%, or lower than 6.5%
- Women who are either pregnant or lactating
- Participation in another clinical study in the month preceding recruitment into the study.
- Patients who cannot guarantee compliance.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Internal Medicine, Infectious Diseases and Diabetology Hopital Robert Bisson (Lisieux)
Lisieux, Normandy, 14107
About this study
Official title: A Comparative, Dose-Escalating, Placebo-Controlled Study of the Efficacy and Safety of PAZ320, Ingested Together With a Standard Meal on Post-Prandial Glucose and Insulin Blood Levels in Type II Diabetic Patients Treated With Metformin
The purpose of this study is to test the efficacy of PAZ320 in diabetic patients.
Read the detailed description
The purpose of the present clinical study is to test the efficacy of two doses of PAZ320 in diabetic patients already on treatment with metformin, in order to assess and quantify its effect on postprandial glucose and insulin levels after a standard meal composed of rice, compared to placebo.
- Conditions
- Type II Diabetes
- Being tested
- PAZ320, Placebo
- Keywords
- PAZ320, Type II diabetes, Metformin, Galactomannan
- 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.
PAZ320Drug
Also called Galactomannan
Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320
PlaceboOther
Treatment arm A - 4 tablets of placebo Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets
| Study group | Role | What they receive |
|---|---|---|
| A - Placebo Control | Placebo comparator | 4 tablets of placebo Receives: Other: Placebo |
| B - PAZ320 Low Dose | Experimental | 2 tablets of PAZ320 and 2 tablet of placebo Receives: Drug: PAZ320; Other: Placebo |
| C - PAZ320 High Dose | Experimental | 4 tablet of PAZ320 Receives: Drug: PAZ320 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the PAZ320 effect on postprandial blood glucose levels in type II diabetic patients.
The extent and duration of PAZ320 effect on postprandial blood glucose levels in type II diabetic patients will be assessed under treatment with metformin, over 4 hours after the intake of a standard meal, using an implanted continuous glucose monitoring device.
Measured: 2 weeks
Secondary outcomes (1)
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
The secondary safety endpoint is number subjects with occurrences of following AEs: injury, surgery, accidents, or illnesses, and significant abnormalities in clinical laboratory values, psychological testing, or physical examination findings. In cases of surgical or diagnostic procedures, the condition/illness leading to such a procedure will be considered as the AE rather than the procedure itself.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study startSep 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LOÏK GEFFRAY, MD, Principal investigator, Department Of Internal Medicine, Infectious Diseases And Diabetology Hopital Robert Bisson (Lisieux) Lisieux, Normandy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569214
- Sponsor's protocol ID
- PAZ320-003
- Acronym
- PAZ320
- Status last verified
- Sep 2020
- First submitted
- 13 Nov 2013
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Dose-Escalating, Placebo-Controlled Study of the Efficacy and Safety of PAZ320, Ingested Together With a Standard Meal on Post-Prandial Glucose and Insulin Blood Levels in Type II Diabetic Patients Treated With Metformin
- ClinicalTrials.gov ID
- NCT04569214
- Acronym / sponsor ID
- PAZ320 / PAZ320-003
- Conditions
- Type II Diabetes
- Keywords
- PAZ320, Type II diabetes, Metformin, Galactomannan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012 (actual)
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 29 Sep 2020 (actual)
- 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 test the efficacy of PAZ320 in diabetic patients.
Detailed description
The purpose of the present clinical study is to test the efficacy of two doses of PAZ320 in diabetic patients already on treatment with metformin, in order to assess and quantify its effect on postprandial glucose and insulin levels after a standard meal composed of rice, compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - Placebo Control | Placebo comparator | Other: Placebo4 tablets of placebo |
| B - PAZ320 Low Dose | Experimental | Drug: PAZ320, Other: Placebo2 tablets of PAZ320 and 2 tablet of placebo |
| C - PAZ320 High Dose | Experimental | Drug: PAZ3204 tablet of PAZ320 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with type II diabetes since at least one year, not presenting any complications of their disease.
- Patients under treatment with Metformin up to 3g/day, given twice or three times daily. Metformin doses should not exceed 3g/day, and should be well tolerated by the patients, its dose should have been stable for the last 3 months before inclusion in the study. Metformin should be taken in the morning of the visit only after the test meal is taken. The next doses of metformin will be taken with meals after the visit, in the habitual order the patient is used to take. The patients should not stop taking metformin during the study, but continue as usual, except that in the mornings of the visits, as the patients arrive in fasting conditions, metformin should be taken after the test meal. If a concomitant combination with an oral anti diabetic agent is given, because of elevated HbA1c levels, it should be taken together with metformin after the test meal.
- Age - between 35 and 65, male and female.
- Females should not be pregnant or breast feeding, women of child bearing potential should guarantee anti-contraceptive measures.
- BMI (body mass index) - between 25 and 32.
Key exclusion criteria (6 listed)
- Patients with other underlying diseases, such as cardiovascular disease, renal disease, peripheral vascular disease or any condition considered to be a complication of diabetes, should be excluded from this study.
- Patients treated with insulin subcutaneous injections or with GLP-1 agonists, or by alpha-glucosidase inhibitors or by glinides should not be included in the study.
- HbA1c higher than 9%, or lower than 6.5%
- Women who are either pregnant or lactating
- Participation in another clinical study in the month preceding recruitment into the 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 |
|---|---|---|
| PAZ320Also: GalactomannanTreatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320 | Drug | B - PAZ320 Low Dose, C - PAZ320 High Dose |
| PlaceboTreatment arm A - 4 tablets of placebo Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets | Other | A - Placebo Control, B - PAZ320 Low Dose |
Primary outcome
Assess the PAZ320 effect on postprandial blood glucose levels in type II diabetic patients.
Time frame: 2 weeks
The extent and duration of PAZ320 effect on postprandial blood glucose levels in type II diabetic patients will be assessed under treatment with metformin, over 4 hours after the intake of a standard meal, using an implanted continuous glucose monitoring device.
1 secondary outcome
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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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.
LOÏK GEFFRAY, MD principal investigator
Department Of Internal Medicine, Infectious Diseases And Diabetology Hopital Robert Bisson (Lisieux) Lisieux, Normandy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PAZ320 in people with Type II Diabetes, run by Boston Therapeutics at 1 site in France.
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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Sep 2020. 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 France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Assess the PAZ320 effect on postprandial blood glucose levels in type II diabetic patients. (time frame: 2 weeks). 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 29 Sep 2020.