Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes

Launched by HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe a new drug called semaglutide is compared to an existing medication called Ozempic® for people with type 2 diabetes who are also taking metformin. The study will last about 44 weeks and involves participants receiving weekly injections of either semaglutide or Ozempic® for 32 weeks, plus a follow-up period of 4 weeks after the treatment ends. The goal is to determine which medication better helps control blood sugar levels in patients who haven't been able to manage their diabetes well with metformin alone.

To join the study, participants need to be between 18 and 75 years old, have a diagnosis of type 2 diabetes, and be taking a stable dose of metformin for at least 6 weeks. They should also have specific blood sugar levels and a healthy weight. Certain health conditions, like other types of diabetes or a history of severe pancreatitis, will prevent someone from participating. Overall, this trial offers an opportunity for eligible individuals to explore new treatment options while contributing to diabetes research.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, age 18-75 years (both inclusive) at the time of signing informed consent
• • 2. Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 6 weeks prior to screening with metformin ≥ 1500 mg (or maximum tolerated dose ≥ 1000 mg)
• • 3. HbA1c 7.5 - 11.0 % (both inclusive) (screening)
• • 4. HbA1c 7.0 - 10.5 % (both inclusive) (randomisation)
• • 5. BMI 18.5-35 kg/m2 (both inclusive)
• Exclusion Criteria:
• • 1. Other types of diabetes besides Type 2 diabetes
• • 2. A history of acute diabetes complications within 6 months before screening
• • 3. A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis
• • 4. Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
• • 5. Acute coronary or cerebrovascular event within 3 months before screening or randomisation
• • 6. Heart failure, New York Heart Association (NYHA) class IV
• • 7. Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 6 weeks before screening. An exception is short-term treatment (≤7 days in total) with insulin in connection with inter-current illness
• • 8. Fasting Plasma Glucose (FPG) ≥ 13.9mmol/L
• • 9. Screening calcitonin value ≥ 35 ng/L (pg/mL)
• • 10. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2
• • 11. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol