The Efficacy and Safety of PAZ320 on PPG and Insulin Bloo... | NCT04569214

NCT04569214

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A - Placebo Control	Placebo Comparator	4 tablets of placebo	Other: Placebo
B - PAZ320 Low Dose	Experimental	2 tablets of PAZ320 and 2 tablet of placebo	Drug: PAZ320 Other: Placebo
C - PAZ320 High Dose	Experimental	4 tablet of PAZ320	Drug: PAZ320

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PAZ320	Drug	Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320	B - PAZ320 Low Dose C - PAZ320 High Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C000598421	PAZ320
C012990	galactomannan