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A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
semaglutide injection
Sponsored by
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

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

Inclusion Criteria: Volunteer to participate in the trial and sign the informed consent form; Diagnosed with type 2 diabetes And Stable daily dose for 4 weeks prior to the day of screening of the metformin formulations (greater than or equal to 1500 mg to less than or equal to 2000 mg or maximum tolerated dose documented greater than or equal to 1000 mg); Male or female, Aged 18-75 years (both inclusive) at the time of signing informed consent; Glycated haemoglobin (HbA1c) of greater than 7.0% to less than or less than or equal to 11.0%. Exclusion Criteria: Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 4 weeks prior to the day of screening. However, short-term insulin treatment for a maximum of 7 days prior to the day of screening is allowed; Systemic corticosteroids (excluding topical and inhaled preparations) within the past 90 days to the day of screening; Known or suspected hypersensitivity to trial product(s) or related products; Have participated in other clinical trials and used investigational drugs within the past 90 days to the day of screening; Heart failure(Subjects presently classified as being in New York Heart Association Class IV); Acute coronary syndrome or cerebrovascular events, including but not limited to acute myocardial infarction, stroke, unstable angina or transient ischaemic attack; Have undergone heart-related surgery; or investigator assessment of severe ECG abnormalities, poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), and other cardiovascular and cerebrovascular disorders that are not suitable within the past 90 days prior to the day of screening; Known to plan to be hospitalized for any surgery at the time of screening; Hyperthyroidism, Cushing's syndrome, Diabetic gastroparesis or other gastrointestinal disorders; Gastrointestinal disorders assessed by investigators as increasing post-medication risk, anorexia, alcohol dependence, drug use, drug dependence, epilepsy, psychiatric illness, need for systemic anti-infective therapy, or other conditions assessed by investigators as affecting endpoint assessment; Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC); History or presence of pancreatitis (acute or chronic); Proliferative diabetic retinopathy. Recurrent severe hypoglycaemia (more than 3 severe hypoglycaemic events) within the past 90 days to the day of screening; Acute metabolic complications within the past 180 days prior to the day of screening; Subjects with calcitonin ≥ 50 ng/L pg/mL) ,AMY ≥3×upper normal limit (UNL), triglyceride ≥5.7 mmol/L( 500 mg/dL) ,eGFR<60 mL/min/1.73 m2,; hemoglobin ≤120 g/L (male) or ≤110 g/L (female), ALT、AST≥ 2.5 ×UNL,TBIL≥2×ULN; History or presence of malignant neoplasms within the last 5 years (except basal or squamous cell skin cancer and carcinoma in situ); The female who is pregnant, breast-feeding or Female/male intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive method; (16))Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Sites / Locations

  • Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

semaglutide injection

ozempic®

Arm Description

Semaglutide 0.25 mg、0.5 mg、1.0mg

Ozempic® 0.25 mg、0.5 mg、1.0mg

Outcomes

Primary Outcome Measures

The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment.

Secondary Outcome Measures

The observed mean change in HbA1c values from baseline after 20 weeks of treatment.
Change From Baseline to Week 20 in Fasting Plasma Glucose (FPG).
Change From Baseline to Week 32 in Fasting Plasma Glucose (FPG).
Change From Baseline to Week 32 in HbA1c < 7.0% of participants.
Change From Baseline to Week 32 in HbA1c≤6.5% of participants.
Change From Baseline to Week 32 in HbA1c < 7.0% of participants with no hypoglycemic events.
Change From Baseline to Week 32 in Body Weight (Kilogram (kg)).
Change From Baseline to Week 32 in Systolic and Diastolic Blood Pressure.
Change From Baseline to Week 32 in Pulse Rate.
Change From Baseline to Week 32 in Fasting Blood Lipids: Total Cholesterol、Low-density Lipoprotein (LDL) Cholesterol、 High-density Lipoprotein (HDL) Cholesterol 、Triglycerides (Ratio to Baseline).

Full Information

First Posted
February 20, 2023
Last Updated
April 13, 2023
Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
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1. Study Identification

Unique Protocol Identification Number
NCT05816057
Brief Title
A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus
Official Title
A Multicenter, Randomized, Open-label, and Parallel Assignment Phase III Study to Compare the Efficacy and Safety of Semaglutide Injection With Ozempic® in Combination With Metformin in the Treatment of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

4. Oversight

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

5. Study Description

Brief Summary
Semaglutide injection is a new drug developed according to Ozempic® biosimilars.This trial is conducted in China. The purpose of this study is to investigate the similarities in the efficacy and safety of semaglutide injection and Ozempic® in the treatment of type 2 diabetes, respectively.
Detailed Description
This study is a multicenter, randomized, open-label, parallel assignment, which plans to enroll 476 patients with type 2 diabetes And Stable daily dose for 4 weeks prior to the day of screening of the metformin formulations (greater than or equal to 1500 mg to less than or equal to 2000 mg or maximum tolerated dose documented greater than or equal to 1000 mg. The study was divided into three phases: screening, baseline and treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
semaglutide injection
Arm Type
Experimental
Arm Description
Semaglutide 0.25 mg、0.5 mg、1.0mg
Arm Title
ozempic®
Arm Type
Active Comparator
Arm Description
Ozempic® 0.25 mg、0.5 mg、1.0mg
Intervention Type
Biological
Intervention Name(s)
semaglutide injection
Intervention Description
The subject will receive either a dose semaglutide once weekly (subcutaneous (s.c.) injection). The initial dose of 0.25 mg is s.c. once weekly, and the dose is increased to 0.5 mg after 4 weeks of administration, and the dose is increased to 1 mg after 4 weeks of 0.5 mg administration, and the dose is continued at a stable dose of 1 mg for 24 weeks.Treatment duration 32 weeks.
Primary Outcome Measure Information:
Title
The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment.
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
The observed mean change in HbA1c values from baseline after 20 weeks of treatment.
Time Frame
20 weeks
Title
Change From Baseline to Week 20 in Fasting Plasma Glucose (FPG).
Time Frame
20 weeks
Title
Change From Baseline to Week 32 in Fasting Plasma Glucose (FPG).
Time Frame
32 weeks
Title
Change From Baseline to Week 32 in HbA1c < 7.0% of participants.
Time Frame
32 weeks
Title
Change From Baseline to Week 32 in HbA1c≤6.5% of participants.
Time Frame
32 weeks
Title
Change From Baseline to Week 32 in HbA1c < 7.0% of participants with no hypoglycemic events.
Time Frame
32 weeks
Title
Change From Baseline to Week 32 in Body Weight (Kilogram (kg)).
Time Frame
32 weeks
Title
Change From Baseline to Week 32 in Systolic and Diastolic Blood Pressure.
Time Frame
32 weeks
Title
Change From Baseline to Week 32 in Pulse Rate.
Time Frame
32 weeks
Title
Change From Baseline to Week 32 in Fasting Blood Lipids: Total Cholesterol、Low-density Lipoprotein (LDL) Cholesterol、 High-density Lipoprotein (HDL) Cholesterol 、Triglycerides (Ratio to Baseline).
Time Frame
32weeks

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: Volunteer to participate in the trial and sign the informed consent form; Diagnosed with type 2 diabetes And Stable daily dose for 4 weeks prior to the day of screening of the metformin formulations (greater than or equal to 1500 mg to less than or equal to 2000 mg or maximum tolerated dose documented greater than or equal to 1000 mg); Male or female, Aged 18-75 years (both inclusive) at the time of signing informed consent; Glycated haemoglobin (HbA1c) of greater than 7.0% to less than or less than or equal to 11.0%. Exclusion Criteria: Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 4 weeks prior to the day of screening. However, short-term insulin treatment for a maximum of 7 days prior to the day of screening is allowed; Systemic corticosteroids (excluding topical and inhaled preparations) within the past 90 days to the day of screening; Known or suspected hypersensitivity to trial product(s) or related products; Have participated in other clinical trials and used investigational drugs within the past 90 days to the day of screening; Heart failure(Subjects presently classified as being in New York Heart Association Class IV); Acute coronary syndrome or cerebrovascular events, including but not limited to acute myocardial infarction, stroke, unstable angina or transient ischaemic attack; Have undergone heart-related surgery; or investigator assessment of severe ECG abnormalities, poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), and other cardiovascular and cerebrovascular disorders that are not suitable within the past 90 days prior to the day of screening; Known to plan to be hospitalized for any surgery at the time of screening; Hyperthyroidism, Cushing's syndrome, Diabetic gastroparesis or other gastrointestinal disorders; Gastrointestinal disorders assessed by investigators as increasing post-medication risk, anorexia, alcohol dependence, drug use, drug dependence, epilepsy, psychiatric illness, need for systemic anti-infective therapy, or other conditions assessed by investigators as affecting endpoint assessment; Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC); History or presence of pancreatitis (acute or chronic); Proliferative diabetic retinopathy. Recurrent severe hypoglycaemia (more than 3 severe hypoglycaemic events) within the past 90 days to the day of screening; Acute metabolic complications within the past 180 days prior to the day of screening; Subjects with calcitonin ≥ 50 ng/L pg/mL) ,AMY ≥3×upper normal limit (UNL), triglyceride ≥5.7 mmol/L( 500 mg/dL) ,eGFR<60 mL/min/1.73 m2,; hemoglobin ≤120 g/L (male) or ≤110 g/L (female), ALT、AST≥ 2.5 ×UNL,TBIL≥2×ULN; History or presence of malignant neoplasms within the last 5 years (except basal or squamous cell skin cancer and carcinoma in situ); The female who is pregnant, breast-feeding or Female/male intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive method; (16))Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaoying Li, M.D.
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus

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