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

Phase 2

Withdrawn

• Conditions: Type II Diabetes
• Interventions: Other: Placebo; Drug: PAZ320

• Registration Number: NCT04569214
• Lead Sponsor: Boston Therapeutics

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.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-11-13
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A - Placebo Control	Placebo	4 tablets of placebo
B - PAZ320 Low Dose	PAZ320	2 tablets of PAZ320 and 2 tablet of placebo
B - PAZ320 Low Dose	Placebo	2 tablets of PAZ320 and 2 tablet of placebo
C - PAZ320 High Dose	PAZ320	4 tablet of PAZ320

Primary Outcome Measures

Name	Time	Method
Assess the PAZ320 effect on postprandial blood glucose levels in type II diabetic patients.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	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.

Trial Locations

Locations (1)

Department of Internal Medicine, Infectious Diseases and Diabetology Hopital Robert Bisson (Lisieux); 🇫🇷 Lisieux, Normandy, France