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NCT03962010 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03962010
Other study ID # GX-G6-002
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2019
Est. completion date July 1, 2022

Study information
Verified date May 2019
Source Genexine, Inc.
Contact Yun Jung Choi, Ph.D
Phone 82 31 628 3210
Email yunjung.choi@genexine.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 78
Est. completion date July 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GX-G6
long acting anti-diabetic drug
• Control
Control

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genexine, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c Week 12
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