Oral sumatripide phase 3 clinical arrival to the primary endpoint

Oral sumatripide phase 3 clinical arrival to the primary endpoint

February 23, 2018 Source: WuXi PharmaTech

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Novo Nordisk today announced the first top-line results of the Phase 3a clinical trial PIONEER 1 in the treatment of adult patients with type 2 diabetes using oral semaglutide. The 26-week global trial examined the efficacy and safety of oral somaglutide in 703 patients with type 2 diabetes.

Type 2 diabetes has more than 200 million patients worldwide. Its pathogenesis is mainly related to unhealthy lifestyles, including obesity, lack of exercise, high-fat and high-sugar diets. Insulin resistance occurs in patients with type 2 diabetes. Therefore, for patients, the simple use of insulin does not work well, and other hypoglycemic drugs are needed to control blood sugar. Glucagon-like peptide-1 (GLP-1) is a hormone secreted by small intestinal cells that promotes insulin secretion and inhibits glucagon secretion after eating to accelerate glucose metabolism while delaying gastric emptying and inhibiting appetite.

Somatoglutide is an analog of natural human glucagon-like peptide-1 (GLP-1) that stimulates insulin production in a glucose-dependent manner, inhibits glucagon secretion, reduces appetite and food intake. Involvement.

â–²The injection version of this new diabetes drug was approved last year (Source: Labiotech.eu)

PIONEER 1 is a 26-week, randomized, double-blind, placebo-controlled, four-group, parallel, multicenter, multinational clinical trial comparing placebo in patients with type 2 diabetes who receive only diet and exercise therapy. The efficacy and safety of oral sumarum peptide once daily at three dose levels was compared. 703 PIONEER 1 patients were randomized to 1:1:1:1 daily, taking oral 3, 7, or 14 mg of sumaglutide or placebo. The primary endpoint was the change in long-term glycemic HbA1c from baseline at week 26. The PIONEER 1 study used two significantly different methods to evaluate the efficacy of oral somaglutide. First, the primary statistical principle. According to the latest regulatory requirements, the efficacy of oral somaglutide was evaluated without regard to treatment adherence and rescue medication. The second is the principle of secondary statistics, which assumes that all patients are compliant with treatment and that rescue medications are not administered to assess the efficacy of oral somaglutide.

Based on the primary statistical principles, the trial reached the primary endpoint of the study. All three doses of oral somaglutide significantly reduced HbA1c compared to placebo. In addition, 14 mg of somaduride significantly reduced body weight compared with placebo. While weight loss was observed in the 7 mg and 3 mg doses, it did not reach statistical significance. According to the secondary statistical principle, patients treated with oral 3, 7, and 14 mg of somaduride decreased 0.8%, 1.3%, and 1.5%, respectively, from the 8.0% baseline of HbA1c, while the placebo group only decreased by 0.1%. 59%, 72%, and 80% of patients taking oral 3, 7, or 14 mg of somatoglutide reached the US Diabetes Association (ADA) HbA1c treatment target of less than 7.0%, compared with 34 patients receiving placebo. %achieve. In addition, patients taking oral 3, 7, and 14 mg of somatoglutide reduced their body mass index (BMI) by an average of 8 kg and a body mass index (BMI) of 31.8 kg per square meter, respectively, by 1.7 kg, 2.5 kg, and 4.1 kg. The patient's weight was reduced by 1.5 kg. Oral somaglutide is safe and well tolerated in this trial.

“The results of the PIONEER 1 trial have been very encouraging, confirming the unprecedented oral efficacy of somaglutide reported in the Phase 2 Diabetes Phase 2 clinical trial,” said Dr. Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer of Novo Nordisk: “We look forward to providing data on the remaining nine PIONEER trials this year and expect to submit regulatory reports in 2019.”

We look forward to hearing more about the positive clinical results of this phase of this new drug this year, and hope that this new drug will better bring recovery to patients with type 2 diabetes.

Reference materials:

[1] Novo Nordisk's Positive Phase III Data for Oral Diabetic Drug Heats Up the Competition

[2] Novo Nordisk successfully completes the first phase 3a trial, PIONEER 1, with oral semaglutide

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