Novo Nordisk released the main results of the sustain Forte trial, a 40 week phase 3B clinical trial conducted in 961 patients with type 2 diabetes who needed intensive treatment.
- Novo Nordisk released the main results of the sustain Forte trial, a 40 week phase 3B clinical trial conducted in 961 patients with type 2 diabetes who needed intensive treatment.
- When analyzed using treatment policy estimates (i.e., treatment outcomes, whether adherence to treatment or initiation of other type 2 diabetes treatment), HbA1c decreased by 2.1% in the 2.0 mg somaluptide group, compared with 1.9% in the 1.0 mg group.
- It is reported that the sustain trial is a continuous clinical development plan for weekly subcutaneous injection of somaluptide injection.
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The aim of this study was to analyze the efficacy and safety of weekly 2.0 mg and 1.0 mg semaglutide as adjuvant therapy for metformin and / or sulfonylureas.
The results showed that 2.0 mg somaluptide significantly reduced glycosylated hemoglobin (HbA1c) at week 40, compared with 1.0 mg once a week treatment, reaching the primary endpoint of the trial.
In assessing the expected outcome of treatment (all persisted and no other type 2 diabetes treatment was initiated), HbA1c was reduced by 2.2% in patients treated with 2.0 mg of somaluptide compared with a 1.9% decrease of 1.9% in patients receiving 1.0 mg of somaluptide, from a higher HbA1c average baseline of 8.9%.
The American Diabetes Association (ADA) set the goal of HbA1c control below 7.0%. 68% of patients in the 2.0 mg somaluptide group and 58% in the 1.0 mg group achieved this goal.
In addition, from the baseline mean body weight of 99.3 kg, patients receiving 2.0 mg of somaluptide lost 6.9 kg, compared with 6.0 kg in the 1.0 mg group, which was also statistically significant.
When analyzed using treatment policy estimates (i.e., treatment outcomes, whether adherence to treatment or initiation of other type 2 diabetes treatment), HbA1c decreased by 2.1% in the 2.0 mg somaluptide group, compared with 1.9% in the 1.0 mg group.
The 2.0 mg group lost 6.4 kg of body weight, compared with 5.6 kg of 1.0 mg group, but there was no significant statistical significance.
At the same time, the experimental data showed that the two doses of somaluptide were safe and well tolerated.
The most common adverse reactions were gastrointestinal diseases, most of which were mild to moderate, and gradually decreased over time, consistent with GLP-1 receptor agonists.
Compared with the 1.0mg dose, the gastrointestinal adverse reactions of 2.0mg somaluptide were similar, and the nausea rates of the two doses were about 15%. The rate of treatment interruption due to adverse events was similar between the two doses, less than 5%.
It is reported that the sustain trial is a continuous clinical development plan for weekly subcutaneous injection of somaluptide injection.
It contains 11 phase-3 global clinical trials, including trials for cardiovascular outcomes, involving more than 11000 adults with type 2 diabetes.
Somaluptide 1.0 mg injection (trade name ozempic) was approved for the treatment of type 2 diabetes in the United States in 2017, and its oral preparation (trade name rybelsus) was approved in 2019, becoming the first glucagon like peptide (GLP-1) receptor protein therapy approved in the United States without injection.
Reference source: once weekly semaglutide 2.0 mg demonstrates superior reduction in HbA1c vs once weekly semaglutide 1.0 mg in people with type 2 diabetes in the sustain Forte trial
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