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
Eligibility Criteria
Inclusion
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 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;
- 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);
- BMI≥18.5kg/m2 and ≤35 kg/m2
- 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) .
- At baseline,HbAlc ≥ 7.0% and ≤ 11.0%(cental lab)
Exclusion
Exclusion Criteria:
- Known or suspected hypersensitivity to any GLP-1RA or related products, or allergicconstitution
- 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).
- 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 endocrineneoplasia syndrome type 2 (MEN 2)
- Have a history of major cardiovascular and cerebrovascular diseases within 90 daysbefore screening.
- 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
ChinaSite Not Available
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