ADA2018: Novo Nordisk announces the latest research progress in 4 diabetes drugs

2023-11-18 21:08:34

June 25, 2018 Source: Sina Pharmaceutical

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The 7818 American Diabetes Association Scientific Conference (ADA2018) was held in Orlando, USA on June 22-26. This is the world's largest and most important diabetes conference with the theme "Diabetes Breakthrough Happen Here." At the conference, diabetes giant Novo Nordisk announced the latest research progress on multiple hypoglycemic agents.

1 , PIONEER 1 study: oral dosage form semaglutide (somaglutide) treatment of type 2 diabetes significantly improved glycemic control

The study was conducted in a 26-week, randomized, double-blind, placebo-controlled, 4-arm, parallel group study in adults with type 2 diabetes. The efficacy and safety of oral semaglutide versus placebo was compared at three dose levels. . Patients were randomized to semaglutide (3, 7, 14 mg) or placebo in a 1:1:1:1 ratio. The primary endpoint was the relative baseline change in glycated hemoglobin (HbA1c) at week 26, and the secondary endpoint HbA1c < 7% compliance and body weight change.

Two methods were used to assess the treatment: the main analysis used the intention-to-treat principle, and the secondary analysis used the on-treatment principle. The data showed that using the principle of intention to treat, the study reached the primary endpoint: three doses of semaglutide significantly reduced HbA1c (p < 0.001) compared with placebo. Specific data: HbA1c decreased by 0.8%, 1.3%, and 1.5%, respectively, in the 3, 7, and 14 mg dose groups, and decreased by 0.1% in the placebo group. The HbA1c <7% compliance rate was 59%, 72%, and 80% in the three dose-treated groups and 34% in the placebo group.

Using the principle of treatment, the 14 mg dose of semaglutide significantly reduced body weight compared with placebo (p < 0.001), but the 3 mg and 7 mg doses of semaglutide did not reach statistically significant differences in body weight loss. Specific data: The body weight of the three dose-treated groups decreased by 1.7, 2.5, and 4.1 kg, respectively, and the placebo group decreased by 1.5 kg. The proportion of patients with a weight loss of â‰¥ 5% was 21%, 29%, and 44% in the three dose-treated groups, and 16% in the placebo group.

In terms of safety, the most common adverse events (>5%) were mild or moderate nausea, with a 5-16% incidence in the semaglutide-treated group and a decrease over time, compared with 6% in the placebo group. Overall, the incidence of adverse events was 58%, 53%, and 57% in the three doses of the semaglutide treatment group and 56% in the placebo group. The rate of treatment interruption due to adverse events was 2%-7%, compared with 2% in the placebo group.

2, SUSTAIN 7 Study: post-analysis Ozempic (Suoma Lu peptide) weight loss effect than Lilly Trulicity (degrees liraglutide)

The study was conducted in adult patients with type 2 diabetes. The post-exploratory analysis used a baseline body mass index (BMI) to assess the secondary endpoint of weight change.

The data showed that subcutaneous injections of 0.5 mg and 1.0 mg doses of Ozempic (semaglutide, weekly) were given once a week in subcutaneous injections of 0.75 mg and 1.5 mg doses of Trulicity (dulaglutide, dulaglutide, developed by Eli Lilly). In the treatment group, the weight of the treatment group was significantly reduced. Regardless of the baseline BMI, the maximum decrease occurred in patients with a BMI >25 kg/m2.

The specific data is: across all BMI subgroups (<25, 25-<30, 30-<35, >35kg/m2), the Ozempic 0.5mg dose group has a weight loss range of 3.6-5.5kg, and the Tulipin 0.75mg dose group is 0.9-3.4kg, Ozempic 1.0mg dose group weight loss range of 5.2-7.6kg, Trulicity 1.5mg dose group of 2.0-3.8kg. Patients with a baseline BMI â‰¥ 25 kg/m2 achieved a greater weight loss after Ozempic treatment compared with patients with a baseline BMI <25 kg/m2. In addition, across all BMI subgroups, the Ozempic treatment group had a higher proportion of patients with weight loss >5% and >10% compared to Trulicity.

In terms of safety, fewer gastrointestinal adverse events were reported in patients treated with 0.75 mg dose of Trulicity across all BMI subgroups. The two most common adverse events of Ozempic are gastrointestinal adverse events.

3 , CONFIRM study: real-world evidence shows that Tresiba's hypoglycemic effect is significantly better than Toujeo (glargine U300 ) and less hypoglycemic events

The study is a large-scale, real-world evidence (RWE) study comparing the efficacy of Tresiba (Delta insulin) relative to Toujeo (Galcerol, U300, Sanofi). This retrospective, non-invasive, comparative study included more than 4,000 adult patients with type 2 diabetes who started basal insulin for the first time. Data showed that after 6 months of treatment, the Trespa treatment group had HbA1c compared with the Toujeo treatment group. Significantly reduced (-1.5% vs -1.2%, p=0.029).

In the secondary endpoint, the incidence of hypoglycemia was 30% lower in the Tresiba treatment group than in the Toujeo treatment group (p=0.045). In another secondary endpoint discontinuation rate, patients treated with Tresiba were more likely to remain treated, while the Toujeo treatment group had a 37% higher rate of discontinuation after 2 years of treatment (p < 0.001).

4 , DUAL IX study: as an oral hypoglycemic agent add-on therapy, Xultophy blood glucose lowering effect is significantly better than the time (U100 )

The study was a 26-week, randomized, open-label, multicenter, phase IIIb study of blood glucose levels in patients receiving sodium-glucose co-transporter-2 inhibitor (SGLT-2i) (with or without other oral hypoglycemic agents). In the poorly controlled adult patients with type 2 diabetes, the efficacy and safety of Xultophy (Degutin/Lilaglutide Injection) as an add-on therapy relative to the time of arrival (Lantus, insulin glargine, U100) was evaluated.

The data showed that Xultophy provided significantly better blood glucose reduction (1.94% vs 1.68%, p<0.0001) compared to time. Other secondary endpoints from the study included changes in body weight, symptomatic hypoglycemia with severe or glycemic confirmation, and a daily insulin dose of 26 weeks. The data showed that the average body weight of the Xultophy treatment group remained unchanged, and the weight of the treatment group increased by 2 kg; the incidence of hypoglycemia in the Xultophy treatment group was 58% lower than that of the treatment group (0.37 event/patient year vs 0.90 event/patient year, p= 0.0035). In terms of mean daily total insulin dose, the Xultophy treatment group was significantly lower than the treatment group (36 units/day vs 54 units/day, p<0.0001). In terms of safety, adverse events were similar in the 2 treatment groups, and the most common adverse events (>5%) in the Xultophy treatment group included virological upper respiratory tract infections, headache, back pain, elevated lipase, and nausea. (Sina Pharmaceutical Compilation/newborn)

Article reference source: Novo Nordisk official website

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