A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients

This study is a Phase 2, randomized, double-blind, placebo-controlled, single-center study in adult patients with type 2 diabetes. It will evaluate the safety and tolerability of oral GLY-200. Subjects will participate in a ≤ 18-day screening period followed by a metformin washout period of approximately 14 days, and an inpatient period of 16 days. Approximately 48 subjects will be randomized to 1 of 3 active treatment groups or 1 of 3 placebo groups. Dosing will occur for 14 days. A follow-up clinic visit will occur on Day 21 [End of Study (EOS)] or Early Termination (ET).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: GLY-200; Drug: GLY-200; Drug: GLY-200; Drug: Placebo; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • ProSciento, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Patients diagnosed with type 2 diabetes: hemoglobin A1c (HbA1c)) ≥ 6.0 and ≤ 8.5% at screening
• Body mass index (BMI) ≥ 18 and ≤ 40 at screening

Key Exclusion Criteria:

• Treated with any prescription medication for the treatment of type 2 diabetes or weight loss other than metformin in the last 3 months prior to screening
• Use of any drug treatment that affects gastric pH
• Use of any drug treatment that affects gastrointestinal motility
• Fasting blood glucose > 190 mg/dL
• Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract or active disease within 12 months prior to screening
• History of any previous abdominal or intestinal surgery including endoscopic, open or laparoscopic thoracic or abdominal surgery, surgical resection of the stomach, small or large intestine
• Clinically significant medical condition as judged by the Investigator that could potentially affect study participation and/or personal well-being

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.5 g GLY-200; 0.5 g GLY-200 (1 x 0.5 g capsule) twice a day (BID)	Drug: GLY-200; 0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12); Drug: GLY-200; 1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12); Drug: GLY-200; 2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)
Experimental: 1.0 g GLY-200; 1.0 g GLY-200 (2 x 0.5 g capsule) twice a day (BID)	Drug: GLY-200; 0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12); Drug: GLY-200; 1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12); Drug: GLY-200; 2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)
Experimental: 2.0 g GLY-200; 2.0 g GLY-200 (4 x 0.5 g capsule) twice a day (BID)	Drug: GLY-200; 0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12); Drug: GLY-200; 1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12); Drug: GLY-200; 2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)
Placebo Comparator: Placebo for 0.5 g GLY-200 arm; 1 placebo capsule twice a day (BID)	Drug: Placebo; 1 placebo capsule BID for 14 days (n=4); Drug: Placebo; 2 placebo capsules BID for 14 days (n=4); Drug: Placebo; 4 placebo capsules BID for 14 days (n=4)
Placebo Comparator: Placebo for 1.0 g GLY-200 arm; 2 placebo capsules twice a day (BID)	Drug: Placebo; 1 placebo capsule BID for 14 days (n=4); Drug: Placebo; 2 placebo capsules BID for 14 days (n=4); Drug: Placebo; 4 placebo capsules BID for 14 days (n=4)
Placebo Comparator: Placebo for 2.0 GLY-200 arm; 4 placebo capsules twice a day (BID)	Drug: Placebo; 1 placebo capsule BID for 14 days (n=4); Drug: Placebo; 2 placebo capsules BID for 14 days (n=4); Drug: Placebo; 4 placebo capsules BID for 14 days (n=4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Glyscend, Inc.
• Investigators: Study Chair: Mark Fineman, PhD, Glyscend, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Diabetes Mellitus, Type 2; GLY-200; Glyscend, Inc.
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GLY-200-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No