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

Boston Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Type II Diabetes

Treatments: Drug: PAZ320; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04569214

PAZ320-003

Details and patient eligibility

About

The purpose of this study is to test the efficacy of PAZ320 in diabetic patients.

Full 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.

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

A - Placebo Control

Placebo Comparator group

Description:

4 tablets of placebo

Treatment:

Other: Placebo

B - PAZ320 Low Dose

Experimental group

Description:

2 tablets of PAZ320 and 2 tablet of placebo

Treatment:

Other: Placebo

Drug: PAZ320

C - PAZ320 High Dose

Experimental group

Description:

4 tablet of PAZ320

Treatment:

Drug: PAZ320