Investigational 2.0 mg Dose of Ozempic® (Semaglutide) Demonstrates Superior Glycemic Control and Weight Loss Compared to 1.0 mg in Adults with Type 2 Diabetes: Phase 3b SUSTAIN FORTE Trial Results

June 29, 2021 /BioonBIOON/ -- Novo Nordisk at the recently held U.S.Diabetes mellitusAmerican Diabetes Association (ADA) 81st Scientific SessionsMeetingannounced on the antidiabetic drug Ozempic (Chinese brand name: Nuohetai®, generic name: semaglutide, subcutaneous formulation, once weekly) for the treatment of type 2Diabetes mellitus(T2D) Phase 3b SUSTAIN FORTE trial results. The data show that,Compared with the approved 1.0 mg dose of Ozempic, the investigational 2.0 mg dose of Ozempic demonstrated statistically significant and superior efficacy in lowering blood glucose (HbA1c).

Ozempic is a once-weekly glucagon-like peptide-1 (GLP-1) analogue. The drug is a subcutaneous injection formulation, with currently approved doses of 0.5 mg and 1.0 mg, indicated for: (1) as an adjunct to diet and exercise to improve type 2Diabetes mellitusGlycemic control in adult patients; (2) for type 2 diabetes with cardiovascular disease (CVD)DiabetesIn adult patients, to reduce the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke).

Based on the results of the SUSTAIN FORTE trial, in May this year, Novo Nordisk submitted to the U.S.FDAA label expansion application was resubmitted to introduce a new 2.0 mg dose under the existing marketing authorization for Ozempic.

SUSTAIN FORTE Trial Results

SUSTAIN FORTE is a 40-week, phase 3b efficacy and safety trial that enrolled 961 adult patients with type 2 diabetes requiring intensified therapy (additional glycemic control). The trial evaluated once-weekly subcutaneous semaglutide 2.0 mg versus semaglutide 1.0 mg as an add-on to metformin and/or sulfonylureas. The primary endpoint was the reduction in HbA1c levels at week 40. The data analysis presented at the meeting employed a statistical methodology based on the "trial product" estimand, which reflects the treatment effect under the assumption that all patients adhered to the study medication and did not initiate other antidiabetic therapies.

The results showed that the trial met its primary endpoint.: After 40 weeks of treatment, the 2.0 mg dose group demonstrated a statistically significantly greater reduction in HbA1c levels compared to the 1.0 mg dose group (HbA1c reduction from baseline: 2.2% vs. 1.9%).. In addition,The 2.0 mg dose group also demonstrated superiority in weight loss (6.9 kg vs. 6.0 kg).。Further post-hoc analysis of baseline BMI subgroups showed that, compared with the 1.0 mg dose, the 2.0 mg dose resulted in a greater reduction in body weight.In the primary analysis, the incidence of adverse events (AEs) was similar for both doses across all baseline HbA1c and BMI subgroups. The most common adverse events were gastrointestinal events (nausea, diarrhea, and vomiting), consistent with the adverse event profile of the GLP-1 receptor agonist class.

Martin Lange, Executive Vice President at Novo Nordisk, stated: “Ozempic has helped millions of patients with type 2 diabetes worldwide lower their blood glucose levels, reduce the risk of major adverse cardiovascular events in patients with cardiovascular disease, and help some patients reduce body weight. For nearly a century, our mission has been to drive transformation and innovation in diabetes care to improve the lives of people with diabetes. The data presented at this meeting indicate that with a higher 2.0 mg dose of semaglutide, we can help more patients with type 2 diabetes who have not achieved glycemic control to lower their HbA1c.”

Semaglutide is a human glucagon-like peptide-1 (GLP-1) analog that stimulates insulin secretion and suppresses glucagon secretion in a glucose concentration-dependent manner. It significantly improves glycemic control in patients with type 2 diabetes mellitus while carrying a low risk of hypoglycemia. Additionally, semaglutide can also induce, by reducing appetite and decreasing food intake,Weight LossIn addition, semaglutide can also significantly reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes.

In China, Ozempic® (1.0 mg, 0.5 mg) was approved in April 2021 for the treatment of patients with type 2 diabetes (T2D) to improve glycemic control.Ozempic® is a novel long-acting glucagon-like peptide-1 (GLP-1) analogue with a half-life of up to 7 days, suitable for once-weekly administration and characterized by stable plasma drug concentrations. Combining high potency, long duration of action, and multi-faceted benefits, Ozempic® will not only effectively help patients achieve and maintain stable glycemic targets, but also provide long-term protection through comprehensive cardiovascular and metabolic benefits. It significantly improves medication adherence, enhances patients' quality of life, and empowers them to return to a balanced, carefree lifestyle.

In China, the number of patients with diabetes exceeds 129.8 million, of whom only 15.8% achieve glycemic control targets. Diabetes predisposes individuals to macrovascular and microvascular complications, as well as other adverse outcomes, severely impairing patients' quality of life and increasing their disease burden. Cardiovascular disease is the leading cause of mortality in patients with type 2 diabetes. In China, one in every three patients with diabetes has cardiovascular disease. Suboptimal glycemic control and inadequate management of cardiometabolic risk factors, such as blood pressure, blood lipids, and body weight, are the primary drivers of the high complication rates among diabetic patients in China. Therefore, diabetes management should focus on comprehensive patient benefits, balancing glycemic control with cardiovascular outcomes, and implementing integrated management of multiple risk factors.

As a blockbuster once-weekly GLP-1 product, Nuohetai® extends its half-life to 7 days through breakthrough technology, enabling once-weekly dosing. It delivers potent glycemic control, precise target attainment, and comprehensive cardiovascular and metabolic benefits, providing a more effective, convenient, and safe treatment option for patients with type 2 diabetes in China. The approval of Nuohetai® will further drive the transformation of diabetes treatment practices and therapeutic paradigms in China, facilitate comprehensive disease management, improve long-term clinical outcomes, and help patients return to a life at ease. (Bioon.com)

Original Source:Investigational 2.0 mg dose of Ozempic® (semaglutide) demonstrates superior reductions in blood sugar vs Ozempic® 1.0 mg in adults with type 2 diabetes in a phase 3 trial