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

NCT05950516 | Unknown Phase 3

• 1 other identifier: QLG2065-301
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

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

  Week 33

Secondary Outcomes (5)

• Change in HbA1c

  Week 21

• Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5%

  Week 21, 33

• Change in Fasting Glucose

  Week 21, 33

• Change in Body Weight

  Week 21, 33

• Percentage of Participants That Achieved Body Weight Loss ≥5%

  Week 21, 33

Study Arms (2)

QLG2065

EXPERIMENTAL

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

Drug: Semaglutide

Ozempic

ACTIVE COMPARATOR

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

Drug: Semaglutide Pen Injector [Ozempic]

Interventions

Semaglutide DRUG

Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks

Also known as: QLG2065

QLG2065

Semaglutide Pen Injector [Ozempic] DRUG

Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks

Also known as: Ozempic Injectable Product

Ozempic

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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）

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jiajun Zhao

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuanzheng Han

CONTACT

0531-55821374; chuanzheng2.han@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 18, 2023
• Study Start: July 10, 2023
• Primary Completion: November 24, 2024
• Study Completion: January 22, 2025
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)