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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: GLY-200
* Drug: GLY-200
* Drug: GLY-200
* Drug: Placebo
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 g GLY-200<br> | Drug: GLY-200<br>* 0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)<br>|
| Experimental: 1.0 g GLY-200<br> | Drug: GLY-200<br>* 1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12)<br>|
| Experimental: 2.0 g GLY-200<br> | Drug: GLY-200<br>* 2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)<br>|
| Placebo Comparator: Placebo for 0.5 g GLY-200 arm<br> | Drug: Placebo<br>* 1 placebo capsule BID for 14 days (n=4)<br>|
| Placebo Comparator: Placebo for 1.0 g GLY-200 arm<br> | Drug: Placebo<br>* 2 placebo capsules BID for 14 days (n=4)<br>|
| Placebo Comparator: Placebo for 2.0 GLY-200 arm<br> | Drug: Placebo<br>* 4 placebo capsules BID for 14 days (n=4)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose |  | Day 1, Day 7, and Day 14 | 
| Change from baseline in fasting plasma insulin |  | Day 1, Day 7, and Day 14 | 
| Change from baseline in 3-hours postprandial plasma glucose profile |  | Day 1, Day 7, and Day 14 | 
| Change from baseline in 3-hours postprandial plasma insulin profile |  | Day 1, Day 7, and Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Diabetes Mellitus, Type 2, GLY-200, Glyscend, Inc.