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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05478525
• Other study ID #: GLY-200-02
• Status: Completed
• Phase: Phase 2
• Start date: August 3, 2022
• Est. completion date: March 14, 2023

Study information

• Verified date: January 2024
• Source: Glyscend, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• GLY-200
0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)
• GLY-200
1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12)
• GLY-200
2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)
• Placebo
1 placebo capsule BID for 14 days (n=4)
• Placebo
2 placebo capsules BID for 14 days (n=4)
• Placebo
4 placebo capsules BID for 14 days (n=4)

Locations

Country	Name	City	State
United States	ProSciento, Inc.	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Glyscend, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 plasma glucose		Day 1, Day 7, and Day 14
Secondary	Change from baseline in fasting plasma insulin		Day 1, Day 7, and Day 14
Secondary	Change from baseline in 3-hours postprandial plasma glucose profile		Day 1, Day 7, and Day 14
Secondary	Change from baseline in 3-hours postprandial plasma insulin profile		Day 1, Day 7, and Day 14