Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGGX-G6
long acting anti-diabetic drug
DRUGControl
Control
Sponsors
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | Week 12 |
Contacts
Primary ContactYun Jung Choi, Ph.D
Outcome results
None listed