At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GLY-200 and Placebo for Type 2 Diabetes. Completed, enrolled 51 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)
1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12)
2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)
1 placebo capsule BID for 14 days (n=4)
2 placebo capsules BID for 14 days (n=4)
4 placebo capsules BID for 14 days (n=4)