Clinical trial NCT04569214: The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Type II Diabetes
Keywords: PAZ320
Type II diabetes
Metformin
Galactomannan
Lead sponsor: Boston Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assess the PAZ320 effect on postprandial blood glucose levels in type II diabetic patients.
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lisieux
country: France
facility: Department of Internal Medicine, Infectious Diseases and Diabetology Hopital Robert Bisson (Lisieux)
state: Normandy
Study officials:
affiliation: Department Of Internal Medicine, Infectious Diseases And Diabetology Hopital Robert Bisson (Lisieux) Lisieux, Normandy, France
name: LOÏK GEFFRAY, MD
role: PRINCIPAL_INVESTIGATOR
References: