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Clinical Trial Details

Trial ID: L2223
Source ID: NCT05478525
Associated Drug: Gly-200
Title: A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05478525/results
Conditions: Type 2 Diabetes
Interventions: DRUG: GLY-200|DRUG: GLY-200|DRUG: GLY-200|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: Number of Participants With Adverse Events [Safety and Tolerability of GLY-200], Safety and tolerability will be assessed by incidence of adverse events (AEs). Clinically significant changes from baseline in vital signs, clinical laboratory parameters, and electrocardiograms (ECGs) will be recorded as AEs., Over the 14-day treatment period | Secondary: Change From Baseline in Fasting Glucose, Evaluate change from baseline (Day 1) in fasting glucose as captured via continuous glucose monitoring (CGM) at Week 1 and Week 2, Day 1, Day 7, and Day 14|Change From Baseline in Fasting Plasma Insulin, Evaluate change from baseline in fasting plasma insulin at Day 1, Day 7, and Day 14, Day 1, Day 7, and Day 14|Change From Baseline in 3-hours Postprandial Plasma Glucose Profile, Evaluate change from baseline in Area Under the Curve (AUC) glucose during mixed meal tolerance tests (MMTTs) at Day 1, Day 7, and Day 14. AUC is calculated from -60 to 180 min using the trapezoidal rule., Day 1, Day 7, and Day 14|Change From Baseline in 3-hours Postprandial Plasma Insulin Profile, Evaluate change from baseline in Area Under the Curve (AUC) insulin during mixed meal tolerance tests (MMTTs) at Day 1, Day 7, and Day 14. AUC is calculated from -60 to 180 min using the trapezoidal rule., Day 1, Day 7, and Day 14
Sponsor/Collaborators: Sponsor: Glyscend, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 51
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-03
Completion Date: 2023-03-14
Results First Posted: 2025-02-10
Last Update Posted: 2025-02-10
Locations: ProSciento, Inc., Chula Vista, California, 91911, United States
URL: https://clinicaltrials.gov/show/NCT05478525