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出境医 / 临床实验 / A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus

A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Week 12 ]

Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yun Jung Choi, Ph.D 82 31 628 3210 yunjung.choi@genexine.com

Sponsors and Collaborators
Genexine, Inc.
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date May 23, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Change in HbA1c [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: GX-G6
    long acting anti-diabetic drug
  • Drug: Control
    Control
Study Arms  ICMJE
  • Experimental: Dose level 1
    Intervention: Drug: GX-G6
  • Experimental: Dose level 2
    Intervention: Drug: GX-G6
  • Experimental: Dose level 3
    Intervention: Drug: GX-G6
  • Experimental: Dose level 4
    Intervention: Drug: GX-G6
  • Placebo Comparator: Placebo
    Intervention: Drug: Control
  • Active Comparator: Dulaglutide
    Intervention: Drug: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yun Jung Choi, Ph.D 82 31 628 3210 yunjung.choi@genexine.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962010
Other Study ID Numbers  ICMJE GX-G6-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Genexine, Inc.
Study Sponsor  ICMJE Genexine, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Genexine, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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