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

Last updated: July 11, 2023
Sponsor: Qilu Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Treatment

Semaglutide

Semaglutide Pen Injector [Ozempic]

Clinical Study ID

NCT05950516
QLG2065-301
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

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 onlymetformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day), or receivecombination metformin (dose ≥ 750 mg/day) and another OAD (alpha-glucosidaseinhibitors, sulfonylureas, glinides, SGLT-2i or thiazolidinedione), stable treatmentis defined as unchanged medication and daily doses;
  4. At the time of screening, for those who have previously been treated with metforminalone, HbA1c ≥ 7.0% and ≤ 11.0%(local lab); for those who have previously usedmetformin in combination with another OAD treatment, HbA1c ≥ 7.0% and ≤10.0%(locallab);
  5. BMI≥18.5kg/m2 and ≤35 kg/m2
  6. Subjects voluntarily participate in this research, can communicate well withresearchers, are willing to maintain the same diet and exercise habits throughout thestudy, and sign an informed consent form (ICF) .
  7. At baseline,HbAlc ≥ 7.0% and ≤ 11.0%(cental lab)

Exclusion

Exclusion Criteria:

  1. Known or suspected hypersensitivity to any GLP-1RA or related products, or allergicconstitution
  2. Treatment with GLP-1RA, DPP-4 inhibitor, or insulin in a period of 60 days beforescreening. 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 endocrineneoplasia syndrome type 2 (MEN 2)
  6. Have a history of major cardiovascular and cerebrovascular diseases within 90 daysbefore screening.
  7. Known proliferative retinopathy or maculopathy

Study Design

Total Participants: 478
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
July 10, 2023
Estimated Completion Date:
January 22, 2025

Connect with a study center

  • Shandong Provincial Hospital

    Jinan, Shandong
    China

    Site Not Available

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