drugset / Trial / NCT02477865
Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 Patients
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a phase III, multicenter, randomized, double-blind, placebo-controlled study planning to include approximately 387 T2DM patients who have received at least 8 weeks of treatment with diet control and exercise; have not received any glucose-lowering agents within the 8 weeks prior to screening; and have inadequately controlled blood glucose.The subjects would receive PEX168 or placebo monotherapy for 52weeks in total.
Timeline
- Start
- 2014-03-23
- Primary completion
- 2016-05-15
- Completion
- 2017-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEGLOXENATIDE | Peptide | 100 ug | Subcutaneous |
| Subject | PEGLOXENATIDE | Peptide | 200 ug | Subcutaneous |