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

Genexine

Status and phase: Unknown; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Control; Drug: GX-G6

Study type: Interventional

Funder types: Industry

Identifiers

NCT03962010

GX-G6-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 6 patient groups, including a placebo group

Dose level 1

Experimental group

Treatment:

Drug: GX-G6

Dose level 2

Experimental group

Treatment:

Drug: GX-G6

Dose level 3

Experimental group

Treatment:

Drug: GX-G6

Dose level 4

Experimental group

Treatment:

Drug: GX-G6

Placebo

Placebo Comparator group

Treatment:

Drug: Control

Dulaglutide

Active Comparator group

Treatment:

Drug: Control