NCT03962010UnknownPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Genexine, Inc.
- Enrollment
- 78
- Primary Endpoint
- Change in HbA1c
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dose level 1
Experimental
Intervention: GX-G6 (Drug)
Dose level 2
Experimental
Intervention: GX-G6 (Drug)
Dose level 3
Experimental
Intervention: GX-G6 (Drug)
Dose level 4
Experimental
Intervention: GX-G6 (Drug)
Placebo
Placebo Comparator
Intervention: Control (Drug)
Dulaglutide
Active Comparator
Intervention: Control (Drug)
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: Week 12
Secondary Outcomes
No secondary outcomes reported
Investigators
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