drugset / Trial / NCT02477969
Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study that will enroll approximately 564 T2DM patients who before screening have inadequately controlled blood glucose (7.0%≤HbA1c≤10.5% at randomization)despite at least 8 weeks of metformin monotherapy at stable doses(≥1500 mg/day).
Timeline
- Start
- 2014-02-27
- Primary completion
- 2016-06-22
- Completion
- 2017-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEGLOXENATIDE | Peptide | 100 ug | Subcutaneous |
| Subject | PEGLOXENATIDE | Peptide | 200 ug | Subcutaneous |
| Background | Metformin | Small molecule | 0.5 mg | Oral |