ADA2018: Johnson & Johnson, Eli Lilly, and Merck announce the latest developments in diabetes drugs

ADA2018: Johnson & Johnson, Eli Lilly, and Merck announce the latest developments in diabetes drugs

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, the largest and most important diabetes conference in the world. At this meeting, Johnson & Johnson, Eli Lilly and Merck East announced the latest progress of their diabetes drugs.

1 , Johnson & Johnson

(1 ) Real-world data: Invokana has a greater weight loss and better treatment compliance than GLP-1 receptor agonists

At the meeting, Johnson & Johnson released new data on two real-world studies comparing oral Invokana and injectable GLP-1 receptor agonist (GLP-1) for type 2 diabetes. The first study (abstract number: 1287-P) evaluated patients with type 2 diabetes who initiated Invokana treatment or a GLP-1 treatment based on medical request data from the HealthCore Comprehensive Research Database. Patient data were collected every 3 months. From 12 months before starting treatment to 12 months after treatment. The data showed that Invokana achieved A1C-level glycemic control similar to GLP-1 and showed better results at multiple endpoints, including: (1) 10% improvement in treatment adherence (defined as 12-month treatment period) The proportion of patients taking more than 80% of the drug days, 47.5% vs 37.5%); (2) 22% reduction in treatment interruption (49.5% vs 57.4%, p<0.001) or initiation of insulin therapy (4.1% vs 7.8%, p=0.001) (3) The cost of treatment was reduced by 31% (Invokana was reduced by $1,421 compared to GLP-1 therapy).

The second study (abstract number: 1291-P) was based on a health record from the US Optum database, which showed that Invokana treatment achieved greater and longer-lasting weight loss compared to GLP-1. Specific data were: Invokana treatment significantly decreased after 6 months (104.4 kg vs 108.4 kg, p<0.05) and 9 months (101.1 kg vs 110.2 kg, p<0.05). In addition, the duration of clinically significant weight loss in Invokana treatment was significantly prolonged (133 days vs 103 days, p=0.01).

(2 ) Real-world data: oral Invokana (cagliflozin ) has no increased risk of amputation of lower limbs (BKLE ) compared to other hypoglycemic agents

The data comes from the OBSERVE-4D study, which is the largest and most comprehensive real-world study evaluating a wide range of hypoglycemic agents, covering more than 700,000 patients with type 2 diabetes in the United States, and evaluating BKLE amputation and heart failure hospitalization (HHF). )risk. The data showed that Invokana did not increase the BKLE cut-off risk compared to SGLT-2 inhibitor (SGLT-2i) or non-SGLT-2 inhibitor hypoglycemic agents. The specific data are: (1) Invokana vs all non-SGLT-2i: HR (95% CI) = 0.75 (0.40-1.41), p = 0.30; (2) Invokana vs other SGLT-2i: HR (95% CI) = 1.14 (0.67-1.93), p=0.53; (3) Other SGLT-2i vs all non-SGLT-2i: HR (95% CI) = 0.84 (0.27-2.55), p=0.68. In the subgroup of patients with cardiovascular disease, the amputation rate was consistent: (1) Invokana vs all non-SGLT-2i: HR (95% CI) = 0.72 (0.34-1.51), p = 0.29; (2) Invokana vs other SGLT-2i: HR (95% CI) = 1.08 (0.63-1.82), p = 0.85.

In addition, HFF risk showed positive results: (1) Invokana had a 61% reduction in HHF risk compared to non-SGLT-2i: HR=0.39 (95% CI: 0.26-0.60, p=0.01); (2) Invokana and other SGLT -2i is similar to HHF risk: HR (CI) = 0.90: 0.71-1.13, p = 0.28.

2 , Lilly

(1 ) Phase II clinical trial: Two doses of Trulicity have a strong hypoglycemic effect in treating type 2 diabetes compared with placebo

The study was a double-blind, randomized, parallel-group, placebo-controlled, 18-week, phase II study conducted in adult patients with type 2 diabetes who were or did not receive metformin. Two experimental doses of Urbanic (4.5 mg were evaluated). And 3.0 mg) is superior to the approved dose (1.5 mg) and placebo in reducing A1C.

The data showed that after 18 weeks of treatment, the two experimental doses (4.5 mg and 3.0 mg) of the treatment group showed superiority in reducing A1C while significantly reducing body weight. The specific data were 4.5mg, 3.0mg, 1.5mg, and placebo treatment group A1C decreased by 1.50%, 1.47%, 1.24%, 0.42%, and body weight decreased by 4.4kg, 4.2kg, 2.9kg, 1.6kg, respectively. .

In terms of safety, the most common side effects are gastrointestinal-related and consistent with GLP-RA drugs, including: nausea (30.3%, 21.4%, 22.2% in the 4.5 mg, 3.0 mg, 1.5 mg treatment groups, respectively) and vomiting ( The 4.5 mg, 3.0 mg, and 1.5 mg treatment groups were 13.2%, 10.1%, and 10.1%, respectively. There were no serious hypoglycemic events in each treatment group.

(2 ) Milestone study: Jardiance significantly reduces the risk of kidney disease progression in patients with type 2 diabetes with cardiovascular disease

The results came from two analyses of the milestone study EMPA-REG OUTCOME (NCT01131676). The study was a long-term, multicenter, randomized, double-blind, placebo-controlled study enrolling more than 7,000 patients with type 2 diabetes with cardiovascular disease in 42 countries. The efficacy of Jardiance (10 mg or 25 mg) added to standard care versus placebo plus standard care was assessed. Standard care includes hypoglycemic agents and cardiovascular drugs. The primary endpoint was cardiovascular death, non-fatal heart attack, or non-fatal stroke time. Kidney prognosis is part of an exploratory analysis.

In the first analysis, Jardiance reduced the risk of CV death or heart failure hospitalization in adults with type 2 diabetes with cardiovascular disease, regardless of the cardiovascular risk of the patient at the initiation of the study. The second analysis showed that Jardiance consistently reduced new or worsened kidney disease compared with placebo, regardless of patient blood pressure control, LDL cholesterol levels, or A1C levels.

3 , Merck

(1 ) CompoSIT-I study: Januvia (sitagliptin , sitagliptin) exhibits sustained hypoglycemic efficacy in patients with type 2 diabetes who initiate insulin therapy

The study was a randomized, controlled, double-blind study of metformin and Januvia combination therapy for type 2 diabetes with poorly controlled blood glucose levels and soon to initiate insulin therapy. Data show that stopping Januvia treatment with insulin therapy In contrast, the initiation of insulin therapy while continuing Januvia treatment resulted in a greater reduction in blood glucose levels (1.88% vs 1.42%, difference between groups -0.46%, p<0.001), and a higher proportion of patients achieved A1C <7.0 % of treatment goals (54% vs 35%, 18.8% difference between groups, p<0.001), while no risk of hypoglycemia increased (1.55 events/patient year vs 2.12 events/patient year, p=0.039), daily insulin dose more Low (53.2 units vs 61.3 units, p=0.016).

(2) CompoSIT-R Study: Januvia hypoglycemic effective than Farxiga (dapagliflozin)

The study was a randomized, double-blind, positive drug-controlled study in patients with type 2 diabetes who had mild renal impairment who were taking metformin (with or without sulfonylureas) but had poor glycemic control. The efficacy and safety of Januvia and Farxiga (dapagliflozin, dagliflozin, developed by AstraZeneca) as an add-on therapy were evaluated.

The data showed that Januvia showed non-inferiority and superiority in reducing A1C compared with Farxiga at week 24 (-0.51% vs -0.36%, difference between groups -0.15%, p=0.006), A1C The proportion of patients with <7% compliance was higher (43% vs 27%, 16% difference between groups). (Sina Pharmaceutical Compilation/newborn)

Article reference source: official website of each company

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