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Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Semaglutide
Semaglutide Pen Injector [Ozempic]
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

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

Inclusion Criteria: Male or female, age ≥ 18 years and ≤75 years old at the time of screening. Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999) Within 60 days before screening, subjects received stable treatment with only metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day), or receive combination metformin (dose ≥ 750 mg/day) and another OAD (alpha-glucosidase inhibitors, sulfonylureas, glinides, SGLT-2i or thiazolidinedione), stable treatment is defined as unchanged medication and daily doses; At the time of screening, for those who have previously been treated with metformin alone, HbA1c ≥ 7.0% and ≤ 11.0%(local lab); for those who have previously used metformin in combination with another OAD treatment, HbA1c ≥ 7.0% and ≤10.0%(local lab); BMI≥18.5kg/m2 and ≤35 kg/m2 Subjects voluntarily participate in this research, can communicate well with researchers, are willing to maintain the same diet and exercise habits throughout the study, and sign an informed consent form (ICF) . At baseline,HbAlc ≥ 7.0% and ≤ 11.0%(cental lab) Exclusion Criteria: Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution Treatment with GLP-1RA, DPP-4 inhibitor, or insulin in a period of 60 days before screening. An exception is short-term insulin therapy (≤7 days in total). History of chronic or acute pancreatitis Screening calcitonin value ≥ 50 ng/L (pg/mL) Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) Have a history of major cardiovascular and cerebrovascular diseases within 90 days before screening. Known proliferative retinopathy or maculopathy

Sites / Locations

  • Shandong Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QLG2065

Ozempic

Arm Description

Up to 1.0 mg semaglutide (QLG2065) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).

Up to 1.0 mg semaglutide (Ozempic) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).

Outcomes

Primary Outcome Measures

Change in HbA1c
Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated

Secondary Outcome Measures

Change in HbA1c
Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated
Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5%
Percentage of participants who achieved HbA1c < 7.0%, HbA1c ≤6.5% is presented
Change in Fasting Glucose
Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated
Change in Body Weight
Change from baseline (week 1) to week 21, 33 in body weight was evaluated
Percentage of Participants That Achieved Body Weight Loss ≥5%
Percentage of participants losing ≥5% of baseline body weight is presented

Full Information

First Posted
July 11, 2023
Last Updated
July 11, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05950516
Brief Title
Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes
Official Title
Efficacy and Safety of Semaglutide Injection (QLG2065) vs. Ozempic® as add-on to Metformin in Type 2 Diabetics.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 10, 2023 (Anticipated)
Primary Completion Date
November 24, 2024 (Anticipated)
Study Completion Date
January 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical 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
To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
QLG2065
Arm Type
Experimental
Arm Description
Up to 1.0 mg semaglutide (QLG2065) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).
Arm Title
Ozempic
Arm Type
Active Comparator
Arm Description
Up to 1.0 mg semaglutide (Ozempic) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Other Intervention Name(s)
QLG2065
Intervention Description
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks
Intervention Type
Drug
Intervention Name(s)
Semaglutide Pen Injector [Ozempic]
Other Intervention Name(s)
Ozempic Injectable Product
Intervention Description
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated
Time Frame
Week 33
Secondary Outcome Measure Information:
Title
Change in HbA1c
Description
Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated
Time Frame
Week 21
Title
Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5%
Description
Percentage of participants who achieved HbA1c < 7.0%, HbA1c ≤6.5% is presented
Time Frame
Week 21, 33
Title
Change in Fasting Glucose
Description
Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated
Time Frame
Week 21, 33
Title
Change in Body Weight
Description
Change from baseline (week 1) to week 21, 33 in body weight was evaluated
Time Frame
Week 21, 33
Title
Percentage of Participants That Achieved Body Weight Loss ≥5%
Description
Percentage of participants losing ≥5% of baseline body weight is presented
Time Frame
Week 21, 33

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: Male or female, age ≥ 18 years and ≤75 years old at the time of screening. Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999) Within 60 days before screening, subjects received stable treatment with only metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day), or receive combination metformin (dose ≥ 750 mg/day) and another OAD (alpha-glucosidase inhibitors, sulfonylureas, glinides, SGLT-2i or thiazolidinedione), stable treatment is defined as unchanged medication and daily doses; At the time of screening, for those who have previously been treated with metformin alone, HbA1c ≥ 7.0% and ≤ 11.0%(local lab); for those who have previously used metformin in combination with another OAD treatment, HbA1c ≥ 7.0% and ≤10.0%(local lab); BMI≥18.5kg/m2 and ≤35 kg/m2 Subjects voluntarily participate in this research, can communicate well with researchers, are willing to maintain the same diet and exercise habits throughout the study, and sign an informed consent form (ICF) . At baseline,HbAlc ≥ 7.0% and ≤ 11.0%(cental lab) Exclusion Criteria: Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution Treatment with GLP-1RA, DPP-4 inhibitor, or insulin in a period of 60 days before screening. An exception is short-term insulin therapy (≤7 days in total). History of chronic or acute pancreatitis Screening calcitonin value ≥ 50 ng/L (pg/mL) Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) Have a history of major cardiovascular and cerebrovascular diseases within 90 days before screening. Known proliferative retinopathy or maculopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuanzheng Han
Phone
0531-55821374
Email
chuanzheng2.han@qilu-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiajun Zhao
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiajun Zhao

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes

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