NCT04569214

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
6.9 years until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

November 13, 2013

Last Update Submit

September 24, 2020

Conditions

Type II Diabetes

Keywords

PAZ320Type II diabetesMetforminGalactomannan

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

    2 weeks

Study Arms (3)

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: PAZ320Other: Placebo

C - PAZ320 High Dose

EXPERIMENTAL

4 tablet of PAZ320

Drug: PAZ320

Interventions

PAZ320DRUG

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

Also known as: Galactomannan
B - PAZ320 Low DoseC - PAZ320 High Dose
PlaceboOTHER

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

A - Placebo ControlB - PAZ320 Low Dose

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with type II diabetes since at least one year, not presenting any complications of their disease.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lisieux, Normandy, 14107, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PAZ320galactomannan

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • LOÏK GEFFRAY, MD

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2013

First Posted

September 29, 2020

Study Start

September 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

FR(1)