A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus

A Phase 2, 12-Week, Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate Efficacy and Safety of GX-G6 on Glycaemic Control Versus Placebo and Open-Label Dulaglutide in Patients With Uncontrolled Type 2 Diabetes Mellitus

GX-G6-002 is a Phase 2, 12-week, randomized, parallel group, multi-centre, double blind, placebo-controlled and an open-label active comparator study.

This study aims to establish the dose-response relationship of 4 dose cohorts of GX-G6 compared with double-blind placebo. These treatment cohorts will also be compared with open-label active control.

Inclusion Criteria:

1. Diagnosis of T2DM ≥ 6 months prior to screening
2. HbA1c level of 7-10% (inclusive)

Exclusion Criteria:

1. Have known type 1 diabetes mellitus (T1DM)
2. History of severe hypoglycaemia defined as ≥ 2 episodes of severe hypoglycaemia within 6 months prior to screening
3. Have had ≥ 2 episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
4. Has fasting serum TG ≥ 500 mg/dL or 9 mmol/L at screening.
5. Patients receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months