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

Phase 2

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
2.0 g GLY-200	GLY-200	2.0 g GLY-200 (4 x 0.5 g capsule) twice a day (BID)
Placebo for 1.0 g GLY-200 arm	Placebo	2 placebo capsules twice a day (BID)
Placebo for 2.0 GLY-200 arm	Placebo	4 placebo capsules twice a day (BID)
0.5 g GLY-200	GLY-200	0.5 g GLY-200 (1 x 0.5 g capsule) twice a day (BID)
Placebo for 0.5 g GLY-200 arm	Placebo	1 placebo capsule twice a day (BID)
1.0 g GLY-200	GLY-200	1.0 g GLY-200 (2 x 0.5 g capsule) twice a day (BID)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]	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 Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Glucose	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
Change From Baseline in 3-hours Postprandial Plasma Insulin Profile	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.
Change From Baseline in Fasting Plasma Insulin	Day 1, Day 7, and Day 14	Evaluate change from baseline in fasting plasma insulin at Day 1, Day 7, and Day 14
Change From Baseline in 3-hours Postprandial Plasma Glucose Profile	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.