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A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
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
Lead sponsor
Asset
Dulaglutide
Subcutaneous · GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
78
estimated
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 7-10%
Primary endpoint
•HbA1c, change
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (1)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Glycemic / diabetes
1 endpointChange in HbA1c
Time frame:Week 12
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.