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The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

Primary Purpose

Type2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rE-4 5 mcg
rE-4 10 mcg
Placebo 5 mcg
Placebo 10 mcg
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes Mellitus focused on measuring rE-4, Exenatide, Metformin, Sulfonylurea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. T2DM
  2. 7.0% ≤ HbA1c ≤ 11.0% at screening
  3. FPG ≤13.8 mmol/L
  4. 19 kg/m2 < BMI <35.0 kg/m2 at screening
  5. All subjects provided written informed consent before participation

Exclusion Criteria:

  1. T1DM
  2. Patients treated previously with Exenatide or GLP-1 similar
  3. At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN
  4. At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L
  5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases
  6. Within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period
  7. History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones)
  8. Patients with severe renal impairment or end-stage renal disease
  9. Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit.
  10. Use of weight loss drugs within 3 months prior to screening visit
  11. Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening.
  12. Severe gastrointestinal disease (e.g., gastroparesis)
  13. Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
  14. Participant who participated in any drug clinical trial within the last 3 months prior to screening visit
  15. History of severe hypersensitivity to rExenatide-4 or any product components

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    rE-4 5 mcg

    rE-4 10 mcg

    Placebo 5 mcg

    Placebo 10 mcg

    Arm Description

    Placebo, then rE-4 5 mcg, then rE-4 5 mcg

    Placebo, then rE-4 5 mcg, then rE-4 10 mcg

    Placebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg

    Placebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg

    Outcomes

    Primary Outcome Measures

    Change in HbA1c from Baseline to Week 30
    Change in HbA1c from Baseline (Day 1) to study termination (Week 30)

    Secondary Outcome Measures

    The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30
    The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by study termination (Week 30)
    Change in body weight from Baseline to each intermediate visit and Week 30
    Change in body weight (kg) from Baseline to each intermediate visit and Week 30
    Change in FPG from Baseline to each intermediate visit and Week 30
    Change in Fasting Plasma Glucose from Baseline to each intermediate visit and Week 30
    Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30
    Change in glucose measurements before and 2h after the start of the morning,midday,and evening meals, and at bedtime from Baseline to Week 16，Week 24 and Week 30

    Full Information

    First Posted
    August 1, 2017
    Last Updated
    August 2, 2017
    Sponsor
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03239119
    Brief Title
    The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
    Official Title
    A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) and Safety of rE-4 in Subjects With Type 2 Diabetes Mellitus Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 30, 2017 (Anticipated)
    Primary Completion Date
    December 30, 2018 (Anticipated)
    Study Completion Date
    January 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.
    Detailed Description
    This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of rE-4 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two rE-4 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin, a sulfonylurea or metformin and a sulfonylurea combination) throughout the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type2 Diabetes Mellitus
    Keywords
    rE-4, Exenatide, Metformin, Sulfonylurea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    456 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rE-4 5 mcg
    Arm Type
    Experimental
    Arm Description
    Placebo, then rE-4 5 mcg, then rE-4 5 mcg
    Arm Title
    rE-4 10 mcg
    Arm Type
    Experimental
    Arm Description
    Placebo, then rE-4 5 mcg, then rE-4 10 mcg
    Arm Title
    Placebo 5 mcg
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg
    Arm Title
    Placebo 10 mcg
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg
    Intervention Type
    Biological
    Intervention Name(s)
    rE-4 5 mcg
    Other Intervention Name(s)
    rExenatide-4
    Intervention Description
    Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 5 mcg for 26 weeks - All are subcutaneously injected twice daily
    Intervention Type
    Biological
    Intervention Name(s)
    rE-4 10 mcg
    Other Intervention Name(s)
    rExenatide-4
    Intervention Description
    Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 10 mcg for 26 weeks - All are subcutaneously injected twice daily
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo 5 mcg
    Intervention Description
    Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 5 mcg for 26 weeks - All are subcutaneously injected twice daily
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo 10 mcg
    Intervention Description
    Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 10 mcg for 26 weeks - All are subcutaneously injected twice daily
    Primary Outcome Measure Information:
    Title
    Change in HbA1c from Baseline to Week 30
    Description
    Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
    Time Frame
    Baseline (Day 1) to Week 30
    Secondary Outcome Measure Information:
    Title
    The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30
    Description
    The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by study termination (Week 30)
    Time Frame
    Baseline (Day 1) and Week 30
    Title
    Change in body weight from Baseline to each intermediate visit and Week 30
    Description
    Change in body weight (kg) from Baseline to each intermediate visit and Week 30
    Time Frame
    Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30
    Title
    Change in FPG from Baseline to each intermediate visit and Week 30
    Description
    Change in Fasting Plasma Glucose from Baseline to each intermediate visit and Week 30
    Time Frame
    Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
    Title
    Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30
    Description
    Change in glucose measurements before and 2h after the start of the morning,midday,and evening meals, and at bedtime from Baseline to Week 16，Week 24 and Week 30
    Time Frame
    Baseline, Week 16，Week 24 and Week 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: T2DM 7.0% ≤ HbA1c ≤ 11.0% at screening FPG ≤13.8 mmol/L 19 kg/m2 < BMI <35.0 kg/m2 at screening All subjects provided written informed consent before participation Exclusion Criteria: T1DM Patients treated previously with Exenatide or GLP-1 similar At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases Within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones) Patients with severe renal impairment or end-stage renal disease Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit. Use of weight loss drugs within 3 months prior to screening visit Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening. Severe gastrointestinal disease (e.g., gastroparesis) Pregnancy or lactation, women of childbearing potential with no effective contraceptive method Participant who participated in any drug clinical trial within the last 3 months prior to screening visit History of severe hypersensitivity to rExenatide-4 or any product components
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    linong Ji, Ph.D
    Phone
    +86-01088325578
    Email
    jiln@bjmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    linong Ji, Ph.D
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

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