The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients (PAZ320)

September 24, 2020 updated by: Boston Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandy
      • Lisieux, Normandy, France, 14107
        • Department of Internal Medicine, Infectious Diseases and Diabetology Hopital Robert Bisson (Lisieux)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients diagnosed with type II diabetes since at least one year, not presenting any complications of their disease.
  2. 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.
  3. Age - between 35 and 65, male and female.
  4. Females should not be pregnant or breast feeding, women of child bearing potential should guarantee anti-contraceptive measures.
  5. BMI (body mass index) - between 25 and 32.
  6. Patients with glycated hemoglobin (HbA1c) lower than 9%, and higher than 6.5%, HbA1c will be determined in the first visit.
  7. Patients who are able to collaborate during the entire duration of the study.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. HbA1c higher than 9%, or lower than 6.5%
  4. Women who are either pregnant or lactating
  5. Participation in another clinical study in the month preceding recruitment into the study.
  6. Patients who cannot guarantee compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: A - Placebo Control
4 tablets of placebo
Other: Placebo
Treatment arm A - 4 tablets of placebo Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets
Experimental: B - PAZ320 Low Dose
2 tablets of PAZ320 and 2 tablet of placebo
Other: Placebo
Treatment arm A - 4 tablets of placebo Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets
Drug: PAZ320
Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320
Other Names:
  • Galactomannan
Experimental: C - PAZ320 High Dose
4 tablet of PAZ320
Drug: PAZ320
Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320
Other Names:
  • Galactomannan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: LOÏK GEFFRAY, MD, Department Of Internal Medicine, Infectious Diseases And Diabetology Hopital Robert Bisson (Lisieux) Lisieux, Normandy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAZ320-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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