Phase 2
N=51
A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05478525 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Participants With Adverse Events [Safety and Tolerability of GLY-200] — 9; 8; 12; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GLY-200 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Glyscend, Inc.
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events [Safety and Tolerability of GLY-200] |
9; 8; 12; 7 | — |
| SECONDARY Change From Baseline in Fasting Glucose |
-10.04; -5.68; -15.61; 4.86; -22.56; -13.23 | 0.0007 sig |
| SECONDARY Change From Baseline in Fasting Plasma Insulin |
-0.25; -1.17; 2.03; 1.02; -1.16; -0.76 | — |
| SECONDARY Change From Baseline in 3-hours Postprandial Plasma Glucose Profile |
8.48; -9.30; -17.01; 1.86; -79.21; -53.19 | 0.0298 sig |
| SECONDARY Change From Baseline in 3-hours Postprandial Plasma Insulin Profile |
-19.49; -3.15; -44.18; 6.13; -20.75; -20.84 | 0.1992 |
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
Data sourced from ClinicalTrials.gov (NCT05478525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.