Table 1.
Basic information and clinical characteristics of clinical trials of glimepiride.
| Identifier | Year | Phase | Subject information | Primary outcome | Status | Intervention | Conclusion |
|---|---|---|---|---|---|---|---|
| NCT01132703 | 2010 | I | 34 health human volunteers | Adverse events. Hypoglycemia and EKG changes |
Completed | RP-1127 Placebo |
Two patients had persistent hypoglycemia. No serious adverse events. |
|
NCT01268683 GAMES Pilot |
2012 | II | 10 participants, clinical diagnosis of anterior circulation of ischemic stroke, baseline MRI DWI volume of 82–210 cm3, 18–70 years of age, and the start of drug infusion ≤ 10 h from symptom onset. | Rate of recruitment. Safety and tolerability. Pharmacokinetics/Pharmacodynamics. Clinical and MRI outcome data |
Completed | RP-1127 | Reduce the cerebral edema, the drug is well-tolerated, without safety risks and severe hypoglycemia side effects. |
|
NCT01794182 GAMES-RP |
2015 (Estimated) | 83 patients, clinical diagnosis of acute severe anterior circulation ischemic stroke, baseline DWI lesion volume of 82–300 cm3, age 18–80 years, and time of symptom onset to start of drug infusion of ≤ 10 h. |
The proportion of patients with a mRS at day 90 ≤4 without decompressive craniectomy. Safety of the drug | uncompleted. end early for financial reasons | RP-1127 Placebo |
Reduce cerebral edema, midline shift and plasma MMP-9 concentration, does not significantly reduce mortality | |
| NCT02864953 | 2021 (Estimated) | III | Estimated 680 participants. Patients with large (MRI-DWI 80–300 cm3) acute MCA ischemic stroke or large hemispheric infarction with NIHSS ≥10, study treatment infusion within 10 h after time of symptom onset. Participants receive thrombectomy, which must be based on post-thrombectomy MRI-DWI |
The proportion of participants with improvement in functional outcome at day 90 assessed via the mRS | Recruiting | BIIB093 Placebo |
No conclusion |
RP-1127, glyburide for injection; MRI, magnetic resonance imaging; DWI, diffusion-weighted imaging; BIIB093, intravenous glyburide; NIHSS, National Institutes of Health stroke scale; MCA, middle cerebral artery; MMP-9, matrix metallopeptidase 9; mRS, modified Rankin Scale; EKG, electrocardiogram; IV, Intravenous injection; rtPA, recombinant-tissue plasminogen activator; GAMES Pilot, Glyburide Advantage in Malignant Edema and Stroke-Pilot; GAMES-RP, Glyburide Advantage in Malignant Edema and Stroke—Remedy Pharmaceuticals.