A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus
NCT ID: NCT06256549
Last Updated: 2024-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
272 participants
INTERVENTIONAL
2023-08-09
2024-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GZR18
GZR18 injection s.c.
GZR18
Titrated to low dose or middle or high dose
Semaglutide
Semaglutide injection s.c.
Semaglutide
Titrated to 1.0 mg once a week
Interventions
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GZR18
Titrated to low dose or middle or high dose
Semaglutide
Titrated to 1.0 mg once a week
Eligibility Criteria
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Inclusion Criteria
(2) According to the diagnostic and classification criteria of diabetes issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria of WHO in 2011, type 2 diabetes was diagnosed for more than 3 months.
(3) Lifestyle intervention and / or unregulated use of antidiabetic drugs within 3 months before screening, or stable use of less than 3 oral hypoglycemic drugs within 3 months before screening.
(4) HbA1c (HbA1c) ≥ 7.0% and ≤ 11% during screening.
(5) Body mass index (BMI) ≥ 18.5 kg/m2.
(6) There is no birth plan within 6 months from the signing of informed consent to the last administration, and those who voluntarily take effective contraceptive measures and have no sperm donation plan. Fertile women are not breastfeeding, and the screening and baseline pregnancy tests must be negative.
(7) Patients fully understand the purpose, nature, methods and possible adverse reactions of the trial, can communicate well with researchers, and can understand and comply with the requirements of this study. During the study, they can maintain a stable diet and exercise lifestyle, and voluntarily sign an informed consent form to enter this study.
Exclusion Criteria
(2) Those who participated in clinical trials of other drugs or devices within 3 months before were screened and given treatment.
(3) Surgery that can lead to weight instability was performed within 2 months before screening, or non-diabetic drugs that affect weight are currently being used or are in the weight loss program and are not in the maintenance stage.
(4) History of alcohol or drug abuse, or positive results of pre-random drug abuse screening (urine screening).
(5) Continuous use of insulin for more than 14 days in one year before screening (the time for gestational diabetes to receive insulin treatment is not within this limit); GLP-1RA drugs were used in the first 6 months; dipeptidyl peptidase-4 (DPP-4) inhibitors were used in the first month.
(6) Growth hormone and other drug treatments determined by researchers to affect insulin levels were performed within 3 months before screening.
(7) Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmotic nonketotic diabetic coma within 6 months before screening.
18 Years
75 Years
ALL
No
Sponsors
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Gan and Lee Pharmaceuticals, USA
INDUSTRY
Responsible Party
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Principal Investigators
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Liyuan Zhao, Ph.D
Role: STUDY_DIRECTOR
Gan & Lee Pharmaceuticals.
Locations
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Gan & Lee Pharmaceuticals Co., Ltd
Beijing, , China
Countries
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Other Identifiers
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GL-GLP-CH2004
Identifier Type: -
Identifier Source: org_study_id
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