- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03962010
A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
May 22, 2019 updated by: Genexine, Inc.
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
78
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yun Jung Choi, Ph.D
- Phone Number: 82 31 628 3210
- Email: yunjung.choi@genexine.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Control
|
EXPERIMENTAL: Dose level 4
|
long acting anti-diabetic drug
|
EXPERIMENTAL: Dose level 1
|
long acting anti-diabetic drug
|
EXPERIMENTAL: Dose level 2
|
long acting anti-diabetic drug
|
EXPERIMENTAL: Dose level 3
|
long acting anti-diabetic drug
|
ACTIVE_COMPARATOR: Dulaglutide
|
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HbA1c
Time Frame: Week 12
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2019
Primary Completion (ANTICIPATED)
June 1, 2022
Study Completion (ANTICIPATED)
July 1, 2022
Study Registration Dates
First Submitted
May 22, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (ACTUAL)
May 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 23, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GX-G6-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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