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

February 6, 2025 updated by: Glyscend, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]
Time Frame: Over the 14-day treatment period
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Glucose
Time Frame: Day 1, Day 7, and Day 14
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
Time Frame: Day 1, Day 7, and Day 14
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
Time Frame: Day 1, Day 7, and Day 14
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
Time Frame: Day 1, Day 7, and Day 14
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glyscend, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mark Fineman, PhD, Glyscend, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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