The purpose of this study is to test the efficacy of PAZ320 in diabetic patients.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Department of Internal Medicine, Infectious Diseases and Diabetology Hopital Robert Bisson (Lisieux)
Lisieux, Normandy, France
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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