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Completed

NCT Number: NCT05478525

A Study Evaluating 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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ProSciento, Inc.

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLY-200

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Glyscend, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2022
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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