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Not yet recruitingNCT05950516Updated Jul 18, 2023

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

A Phase 3 interventional study of Semaglutide and Semaglutide Pen Injector [Ozempic] in Type 2 Diabetes, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-18.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
478
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 478 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, age ≥ 18 years and ≤75 years old at the time of screening.
  2. Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999)
  3. 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;
  4. 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）;
  5. BMI≥18.5kg/m2 and ≤35 kg/m2
  6. 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) .
  7. At baseline，HbAlc ≥ 7.0% and ≤ 11.0%（cental lab）

Exclusion criteria

Exclusion Criteria:

  1. Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution
  2. 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).
  3. History of chronic or acute pancreatitis
  4. Screening calcitonin value ≥ 50 ng/L (pg/mL)
  5. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
  6. Have a history of major cardiovascular and cerebrovascular diseases within 90 days before screening.
  7. Known proliferative retinopathy or maculopathy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
478 participants (estimated)

Study arms

  • Experimental
    QLG2065

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

    Drug: Semaglutide

  • Active comparator
    Ozempic

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

    Drug: Semaglutide Pen Injector [Ozempic]

Interventions

  • DrugSemaglutide

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

    Also known as: QLG2065

  • DrugSemaglutide Pen Injector [Ozempic]

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

    Also known as: Ozempic Injectable Product

06

What researchers measure

Primary outcomes

  1. Change in HbA1c

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

    Time frame: Week 33

Secondary outcomes

  1. Change in HbA1c

    Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated

    Time frame: Week 21

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

    Percentage of participants who achieved HbA1c \< 7.0%, HbA1c ≤6.5% is presented

    Time frame: Week 21, 33

  3. Change in Fasting Glucose

    Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated

    Time frame: Week 21, 33

  4. Change in Body Weight

    Change from baseline (week 1) to week 21, 33 in body weight was evaluated

    Time frame: Week 21, 33

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

    Percentage of participants losing ≥5% of baseline body weight is presented

    Time frame: Week 21, 33

07

Study locations

1 site
  • Shandong Provincial Hospital
    Jinan, Shandong, China
    • Jiajun Zhao · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05950516
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 18, 2023
Start date
Jul 10, 2023 (estimated)
Primary completion
Nov 24, 2024 (estimated)
Completion
Jan 22, 2025 (estimated)
Last update
Jul 18, 2023

Study contacts

Chuanzheng Han
Contact
chuanzheng2.han@qilu-pharma.com
0531-55821374
Jiajun Zhao
principal investigator · Shandong Provincial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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