drugset / Trial / NCT03060980
Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
RandomizedParallel-groupOpen-labelTreatment
Summary
A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
Timeline
- Start
- 2017-03-03
- Primary completion
- 2018-01-26
- Completion
- 2018-01-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |
| Subject | Exenatide | Peptide | 20 ug | — |
| Subject | Exenatide | Peptide | 60 ug | — |
| Subject | Glimepiride | Small molecule | 1 mg | Oral |
| Subject | Glimepiride | Small molecule | 6 mg | Oral |