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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GLY-200

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Diabetes Mellitus, Type 2, GLY-200, Glyscend, Inc.

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Patients diagnosed with type 2 diabetes: HbA1c ≥ 6.0 and ≤ 8.5% at screening
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 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

Sites / Locations

ProSciento, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

0.5 g GLY-200

1.0 g GLY-200

2.0 g GLY-200

Placebo for 0.5 g GLY-200 arm

Placebo for 1.0 g GLY-200 arm

Placebo for 2.0 GLY-200 arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in fasting plasma glucose

Change from baseline in fasting plasma insulin

Change from baseline in 3-hours postprandial plasma glucose profile

Change from baseline in 3-hours postprandial plasma insulin profile

Full Information

NCT ID

NCT05478525

First Posted

July 26, 2022

Last Updated

April 6, 2023

Sponsor

Glyscend, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05478525

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

August 3, 2022 (Actual)

Primary Completion Date

March 14, 2023 (Actual)

Study Completion Date

March 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Glyscend, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Type 2 Diabetes, Diabetes Mellitus, Type 2, GLY-200, Glyscend, Inc.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.5 g GLY-200

Arm Type

Experimental

Arm Title

1.0 g GLY-200

Arm Type

Experimental

Arm Title

2.0 g GLY-200

Arm Type

Experimental

Arm Title

Placebo for 0.5 g GLY-200 arm

Arm Type

Placebo Comparator

Arm Title

Placebo for 1.0 g GLY-200 arm

Arm Type

Placebo Comparator

Arm Title

Placebo for 2.0 GLY-200 arm

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

GLY-200

Intervention Description

0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)

Intervention Type

Drug

Intervention Name(s)

GLY-200

Intervention Description

1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12)

Intervention Type

Drug

Intervention Name(s)

GLY-200

Intervention Description

2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1 placebo capsule BID for 14 days (n=4)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 placebo capsules BID for 14 days (n=4)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

4 placebo capsules BID for 14 days (n=4)

Primary Outcome Measure Information:

Title

Number of participants with adverse events [safety and tolerability of GLY-200]

Description

Time Frame

Over the 14-day treatment period

Secondary Outcome Measure Information:

Title

Change from baseline in fasting plasma glucose

Time Frame

Day 1, Day 7, and Day 14

Title

Change from baseline in fasting plasma insulin

Time Frame

Day 1, Day 7, and Day 14

Title

Change from baseline in 3-hours postprandial plasma glucose profile

Time Frame

Day 1, Day 7, and Day 14

Title

Change from baseline in 3-hours postprandial plasma insulin profile

Time Frame

Day 1, Day 7, and Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Patients diagnosed with type 2 diabetes: HbA1c ≥ 6.0 and ≤ 8.5% at screening 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Fineman, PhD

Organizational Affiliation

Glyscend, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

ProSciento, Inc.

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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