Back to resultsA Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GX-G6
Control
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of T2DM ≥ 6 months prior to screening
- HbA1c level of 7-10% (inclusive)
Exclusion Criteria:
- Have known type 1 diabetes mellitus (T1DM)
- History of severe hypoglycaemia defined as ≥ 2 episodes of severe hypoglycaemia within 6 months prior to screening
- Have had ≥ 2 episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
- Has fasting serum TG ≥ 500 mg/dL or 9 mmol/L at screening.
- Patients receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
Dose level 1
Dose level 2
Dose level 3
Dose level 4
Placebo
Dulaglutide
Arm Description
Outcomes
Primary Outcome Measures
Change in HbA1c
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03962010
Brief Title
A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose level 1
Arm Type
Experimental
Arm Title
Dose level 2
Arm Type
Experimental
Arm Title
Dose level 3
Arm Type
Experimental
Arm Title
Dose level 4
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Dulaglutide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
GX-G6
Intervention Description
long acting anti-diabetic drug
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Control
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of T2DM ≥ 6 months prior to screening
HbA1c level of 7-10% (inclusive)
Exclusion Criteria:
Have known type 1 diabetes mellitus (T1DM)
History of severe hypoglycaemia defined as ≥ 2 episodes of severe hypoglycaemia within 6 months prior to screening
Have had ≥ 2 episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
Has fasting serum TG ≥ 500 mg/dL or 9 mmol/L at screening.
Patients receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Jung Choi, Ph.D
Phone
82 31 628 3210
Email
yunjung.choi@genexine.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
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