| Trial ID: | L3619 |
| Source ID: | NCT04569214
|
| Associated Drug: |
Paz320
|
| Title: |
The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients
|
| Acronym: |
PAZ320
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type II Diabetes
|
| Interventions: |
DRUG: PAZ320|OTHER: Placebo
|
| Outcome Measures: |
Primary: 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: 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., 2 weeks
|
| Sponsor/Collaborators: |
Sponsor: Boston Therapeutics
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09
|
| Completion Date: |
2013-02
|
| Results First Posted: |
|
| Last Update Posted: |
2020-09-29
|
| Locations: |
Department of Internal Medicine, Infectious Diseases and Diabetology Hopital Robert Bisson (Lisieux), Lisieux, Normandy, 14107, France
|
| URL: |
https://clinicaltrials.gov/show/NCT04569214
|
