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.

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:

  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

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
Drug: Control
Control
EXPERIMENTAL: Dose level 4
Drug: GX-G6
long acting anti-diabetic drug
EXPERIMENTAL: Dose level 1
Drug: GX-G6
long acting anti-diabetic drug
EXPERIMENTAL: Dose level 2
Drug: GX-G6
long acting anti-diabetic drug
EXPERIMENTAL: Dose level 3
Drug: GX-G6
long acting anti-diabetic drug
ACTIVE_COMPARATOR: Dulaglutide
Drug: Control
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

Genexine, Inc.

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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