Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes (NCT06339086) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes
478 participantsStarted 2024-04
Plain-language summary
The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment.
Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks.
Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in this study, be able to communicate well with the investigator, understand and voluntarily complete the research process in accordance with this protocol, and sign the Informed Consent Form (ICF).
✓. Male or female, aged ≥18 and ≤75 years old at the time of signing the ICF.
✓. Diagnosis of type 2 diabetes for at least 6 months (WHO, 1999) at screening.
✓. Use a stable dose of metformin for at least 60 days before screening (stable dose of metformin: ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day).
✓. Glycosylated Hemoglobin(HbA1c) \>7.0% and \<11.0% at screening (local lab).
✓. BMI ≥18.5 and ≤35 kg/m2 at screening.
Exclusion criteria
✕. Laboratory tests meeting any of the following criteria at screening:
✕. Calcitonin ≥50ng/L (pg/mL);
✕. Blood amylase ≥3×ULN (upper limit of normal value);