Clinical trial NCT05478525: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Diabetes Mellitus, Type 2
GLY-200
Glyscend, Inc.
Lead sponsor: Glyscend, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]
timeFrame: Over the 14-day treatment period
Secondary outcomes:
measure: Change From Baseline in Fasting Glucose
timeFrame: Day 1, Day 7, and Day 14
measure: Change From Baseline in Fasting Plasma Insulin
timeFrame: Day 1, Day 7, and Day 14
measure: Change From Baseline in 3-hours Postprandial Plasma Glucose Profile
timeFrame: Day 1, Day 7, and Day 14
measure: Change From Baseline in 3-hours Postprandial Plasma Insulin Profile
timeFrame: Day 1, Day 7, and Day 14
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento, Inc.
state: California
Study officials:
affiliation: Glyscend, Inc.
name: Mark Fineman, PhD
role: STUDY_CHAIR
References: