This study is a multicenter, randomized, open, parallel-controlled, Phase III clinical study aimed to evaluate the efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes.
1) Voluntary signing of informed consent; 2) Aged 18-75 years (inclusive) at the time of signing the informed consent, male or female; 3) Diagnosed with type 2 diabetes according to the WHO diabetes diagnostic criteria; 4) Laboratory tests at the research center at screening: 7.5%≤HbA1c≤10.5%; 5) Before randomization, study participants received stable doses of metformin (≥1500mg/day or maximum tolerated dose: <1500mg/day, but ≥1000mg/day) for at least 8 weeks (maximum tolerated dose must be supported by previous medical records); 6) Body mass index (BMI) ≥18.5kg/m2 and ≤35.0kg/m2 at screening; 7) Willing and able to undergo treatment and follow-up as required by the protocol.
Type 1 diabetes, special type of diabetes;
Received hypoglycemic drugs other than metformin (including Chinese medicine) within 8 weeks before randomization;
Used non-diabetes treatment drugs that may have a significant impact on glucose metabolism for 1 week or more within 3 months before randomization, such as glucocorticoids (systemic glucocorticoids used for <7 days, excluding inhalation, ocular medication or topical application), sympathetic nerve stimulants (such as isoproterenol, dopamine, atropine, etc.), growth hormone, high-dose salicylates (300 mg/day and above), danazol, octreotide and anabolic androgenic steroids (such as oxymetholone, oxandrolone, etc.);
Has a history of ≥2 episodes of grade 3 hypoglycemia within 1 year before randomization;
Parallel
F027
DrugThe starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
Ozempic®
DrugThe starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
Change in HbA1c from baseline
Change in HbA1c from baseline
Percentage of Participants Who Achieved HbA1c <6.5%
Percentage of participants who achieved HbA1c < 7.0%
Change in Fasting Glucose
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This trial is not recruiting at the moment. You can still explore other options:
