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

NCT ID: NCT04569214

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-02-28

Brief Summary

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.

Conditions

Type II Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A - Placebo Control

4 tablets of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Treatment arm A - 4 tablets of placebo Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets

B - PAZ320 Low Dose

2 tablets of PAZ320 and 2 tablet of placebo

Group Type: EXPERIMENTAL

PAZ320

Intervention Type: DRUG

Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320

Placebo

Intervention Type: OTHER

Treatment arm A - 4 tablets of placebo Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets

C - PAZ320 High Dose

4 tablet of PAZ320

Group Type: EXPERIMENTAL

PAZ320

Intervention Type: DRUG

Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320

Interventions

PAZ320

Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320

Intervention Type: DRUG

Placebo

Treatment arm A - 4 tablets of placebo Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets

Intervention Type: OTHER

Other Intervention Names

Galactomannan

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LOÏK GEFFRAY, MD

Role: PRINCIPAL_INVESTIGATOR

Department Of Internal Medicine, Infectious Diseases And Diabetology Hopital Robert Bisson (Lisieux) Lisieux, Normandy, France

Locations

Department of Internal Medicine, Infectious Diseases and Diabetology Hopital Robert Bisson (Lisieux)

Lisieux, Normandy, France

Countries

France

Other Identifiers

PAZ320-003

Identifier Type: -

Identifier Source: org_study_id