Competition between two diabetes treatments -- Novo Nordisk’s Tresiba and Sanofi’s Toujeo -- has been heating up with the two firms putting out findings from their trials titled “CONFIRM” and “BRIGHT,” respectively.
|Competition between Novo Nordisk’s Tresiba and Sanofi’s Toujeo heats up in the domestic market with a Korean expert noting Tresiba will maintain its market lead.|
As a result, Tresiba is likely to continue its reign as the market leader for the time being, a Korean expert said.
Novo Nordisk’s Tresiba (insulin degludec) is a once-daily, ultralong-acting basal insulin analog injection to treat people with type 1 or type 2 diabetes approved in March 2014. A 3 mL injection costs 16,876 won ($15).
Sanofi’s Toujeo (insulin glargine) is once-daily, long-acting insulin used to control blood sugar in type 2 diabetes. The therapy, approved in August 2015, is a three-fold concentrated formulation of Lantus (insulin glargine) and boasts a longer half-life. A 1.5 mL of the therapy costs 19,285 won.
According to U-BIST data, Tresiba ranked first in annual outpatient prescriptions last year, selling 12.37 billion won ($11.57 million). Toujeo sold 12.32 billion won. In the first quarter of this year, Novo’s Tresiba sold 3.87 billion won, more than 3.57 billion won sales of Toujeo.
Tresiba’s sales growth was faster than that of Toujeo. Tresiba’s outpatient prescriptions jumped 73 percent from 7.14 billion won in 2016 to 12.37 billion won in 2017. During the same period, Tuojeo’s prescriptions went up 46 percent from 8.45 billion won to 12.32 billion won.
Novo Nordisk publishes real-world CONFIRM study results
At the Scientific Sessions of the American Diabetes Association (ADA), Novo Nordisk presented findings from the CONFIRM trial on 4,056 patients.
The primary endpoint for the CONFIRM trial was a change in blood sugar control (A1C) during six months. Secondary endpoint included the rate of hypoglycemia, the proportion of patients with at least one hypoglycemia episode and the rate of treatment discontinuation.
Results showed Tresiba significantly lowered A1C and rates of hypoglycemia in patients versus Toujeo (-1.5% vs. -1.2%). For its secondary endpoint, the rate of hypoglycemic episodes in the Tresiba group fell by 30 percent compared to Toujeo.
People treated with Tresiba were also more likely to stay on their treatment. Those treated with Sanofi’s Toujeo had a 37 percent higher rate of discontinuing treatment after two years, the study found.
However, CONFIRM contained limitations of real-world evidence that includes underreporting of hypoglycemia, a short follow-up period of three to six months, and limited insight into evidence of prescribed basal insulin and not actual use.
Sanofi presents results from randomized BRIGHT control trial
Sanofi’s BRIGHT trial - also presented at the ADA - was a randomized controlled trial (RCT) that studied 929 adults with type 2 diabetes for more than 24 weeks in a controlled environment.
In the BRIGHT study, Toujeo showed non-inferiority to Novo Nordisk’s Tresiba and met the primary endpoint by demonstrating a reduction in blood sugar (HbA1c) levels.
The rate of “significant” hypoglycemia events (≤54 mg/dL) also dropped 43 percent during the first 12 weeks of the study - called the titration period where patients and physicians work to determine the appropriate insulin dose. That of “mild” hypoglycemia events (≤70 mg/dL) fell 23 percent.
During the second 12 “maintenance” weeks of the study (week 13-24), the two treatments showed similar incidences and rates of hypoglycemic events. The incidence of low blood sugar between the two therapies during the day was also comparable throughout the study (66.5% and 69%).
Tresiba one of most ‘popular basal insulins’ in Korean diabetes market
Korean experts now weigh in on the clinical findings and how it will impact the Korean diabetes market.
Professor Yoon Kun-ho from Seoul St. Mary’s Hospital Department of Endocrinology and Metabolism told Korea Biomedical Review that Sanofi’s RCT could give “Toujeo confidence” to physicians since it proved to lower hypoglycemia rates and showed non-inferiority to Tresiba, which is one of the most popular basal insulins used in practice.
Hypoglycemia is one of the biggest barriers to titrate an appropriate dosage for diabetes patients. Hypoglycemia, more commonly known as low blood sugar, occurs when blood sugar drops to below normal levels resulting in symptoms such as clumsiness, trouble talking, confusion, and loss of consciousness. It may also lead to seizures or death.
“Hypoglycemia is one of the most important barriers to titrate the appropriate dose of insulin for the patients. Also, most of the events of hypoglycemia might happen in the early titration period. If the hypoglycemia had been induced during that time, it might be a big barrier for appropriate titration in the real practice setting,” Yoon said.
Tresiba is one of the most popular basal insulin therapies used in clinical practice. So this study could give confidence about the use of Toujeo for many general physicians, he added.
Professor Chon Suk from Kyung Hee University Hospital Department of Endocrinology and Metabolism told KBR that although Sanofi’s trial proved non-inferiority, Tresiba was launched earlier and differentiated itself from existing insulin therapies that were on the market. The therapy – which holds a higher market share – is likely to continue its reign,
“Both insulin therapies are used much in Korea, but Tresiba came out a bit earlier. It proved to lower hypoglycemia and maintains long-term efficacy compared to other insulins that were on the market, so Tresiba is still being used extensively.”
“Tresiba is being used more now. Toujeo has the same component as Lantus but with three times more insulin and a longer half-life without the peak. So people using Lantus could switch to Toujeo – although people using Tresiba may not switch to Toujeo,” Chon said.
Regarding the trials, Chon pointed out that they differ in design, with each carrying pros and cons, and cannot be compared directly.
“Both the RCT and real-world study carry significance, but RCT trials often carries a higher evidence-level. These types of trials randomly assign similar patients in a similar environment,” Chon said.
However, the CONFIRM trial had more than 4,000 patients, indicating four-times the number of patients in the BRIGHT trial. The study, instead of being randomized, was a retrospective study on the patients who were prescribed Toujeo and Tresiba in a clinical setting, she noted.
“In that regard, the test confirmed the effectiveness of Tresiba,” Chon added.
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