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

NCT05478525 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-02-10

Study results available
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Summary

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).

Conditions

Interventions

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)

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)

Sponsors & Collaborators

  • Glyscend, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Fineman, PhD · Glyscend, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2023-03-14
Completion
2023-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05478525 on ClinicalTrials.gov