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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

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ClinicalTrials.gov Identifier: NCT03962010
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: GX-G6 Drug: Control Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arm Intervention/treatment
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

Experimental: Dose level 4 Drug: GX-G6
long acting anti-diabetic drug

Placebo Comparator: Placebo Drug: Control
Control

Active Comparator: Dulaglutide Drug: Control
Control




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962010


Contacts
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Contact: Yun Jung Choi, Ph.D 82 31 628 3210 yunjung.choi@genexine.com

Sponsors and Collaborators
Genexine, Inc.

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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT03962010     History of Changes
Other Study ID Numbers: GX-G6-002
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs