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

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genexine, Inc.
• Treatments: Dulaglutide

Criteria

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