A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
1 other identifier
interventional
78
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Jun 2019
Longer than P75 for phase_2 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMay 23, 2019
May 1, 2019
3 years
May 22, 2019
May 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Week 12
Study Arms (6)
Dose level 1
EXPERIMENTALDose level 2
EXPERIMENTALDose level 3
EXPERIMENTALDose level 4
EXPERIMENTALPlacebo
PLACEBO COMPARATORDulaglutide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of T2DM ≥ 6 months prior to screening
- HbA1c level of 7-10% (inclusive)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genexine, Inc.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2019
First Posted
May 23, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
May 23, 2019
Record last verified: 2019-05