--Sanofi says data strengthen efficacy profile of Lantus in early treatment
--Lantus, however, is tied to more low-blood-sugar episodes than Januvia
--Amylin's Byetta is superior to older diabetes drug in separate study
By Peter Loftus
Sanofi's (SNY) Lantus insulin reduced blood-sugar levels to a greater degree than did Merck & Co.'s (MRK) Januvia in people with Type 2 diabetes in a clinical trial, researchers said Saturday.
A separate study in a similar patient population concluded that Amylin Pharmaceuticals Inc.'s (AMLN) Byetta was superior to an older drug in controlling the disease.
Sanofi said the results from the Lantus study strengthen the efficacy profile of the drug when introduced early in the course of treatment for diabetes.
However, Lantus was associated with higher rates of low blood-sugar episodes and weight gain compared with Januvia. And given that many patients and doctors prefer to delay the start of insulin treatment, the results may not put a huge dent in Januvia's appeal.
Merck spokeswoman Kelly Dougherty said Januvia provides significant reductions in a measure of blood sugar and, when used by itself, generally isn't associated with excessively low blood sugar or weight gain.
Lantus is a long-acting form of artificial insulin--known as insulin glargine--that is injected once a day. It is Sanofi's top-selling product, with EUR3.92 billion in sales for 2011.
Merck's Januvia is a pill orally administered once daily; it is part of a newer class of drugs known as DPP-4 inhibitors. Januvia had 2011 sales of $3.3 billion and has been one of Merck's fastest-growing products.
Type 2 diabetes is the most common form of diabetes, and is a chronic disease involving high blood-sugar levels. Many patients start drug therapy with an older treatment, metformin. If metformin alone eventually fails to control blood sugar adequately, other treatments may be added including Januvia, other oral agents or injectables.
Lantus and other forms of insulin are commonly introduced later in the course of the disease, after other options fail to adequately control blood sugar. But Lantus is also an alternative to Januvia as a second-line therapy after metformin.
A Sanofi-funded clinical trial set out to compare Lantus head-to-head against Januvia in this second-line setting. About 515 patients with Type 2 diabetes were randomly assigned to receive either Lantus or Januvia, in addition to metformin in both groups, for 24 weeks. Researchers tracked the change in a measure of blood sugar known as HbA1c through the end of treatment.
The average reduction in HbA1c for Lantus users was 1.7%, compared with 1.1% in Januvia users, according to results released Saturday at the annual scientific meeting of the American Diabetes Association in Philadelphia. The data were published online simultaneously by the Lancet, a medical journal.
Lantus patients also were more likely to achieve recommended HbA1c levels than were Januvia users, according to researchers.
However, the average rate of episodes of hypoglycemia, or low blood sugar, was higher among Lantus users than Januvia patients. Some 46% of Lantus users had at least one hypoglycemic event, versus 13% of Januvia users. Low blood sugar can cause fainting or seizures.
Lantus also was associated with weight gain, while Januvia was linked to weight loss. The researchers, however, said rates of severe hypoglycemia were low in Lantus users, and weight gain was mild.
An accompanying commentary in the Lancet said longer studies are needed to assess the long-term effects of both Januvia and Lantus when introduced after metformin in the course of treatment. Studies also should track additional measures such as effects on blood pressure and cholesterol levels, the commentary said.
In a separate study released at the ADA meeting and published by the Lancet, Amylin's Byetta reduced the rate of treatment failure compared with an older drug in a clinical trial of people with Type 2 diabetes.
Byetta is a non-insulin, injectable treatment for diabetes, in a class known as GLP-1 receptor agonists. It is also an option to add to metformin after metformin fails to adequately control blood sugar.
In a study funded by Amylin and its one-time partner for Byetta, Eli Lilly & Co. (LLY), some patients were given Byetta twice daily and others were given glimepiride, an older drug, once daily. Both were added to metformin.
Researchers tracked how many patients in each group had deterioration of blood-sugar control to the point they needed an alternative treatment.
Some 41% of Byetta users had treatment failure, versus 54% of glimepiride patients.
Measured another way, some 44% of Byetta patients achieved an HbA1c concentration of less than 7%, versus 31% of the glimepiride users.
Byetta was associated with a decrease in body weight versus glimepiride. The overall rates of serious adverse events were comparable between the drugs; Byetta was associated with higher rates of certain gastrointestinal symptoms.
Christian Weyer, senior vice president of research and development at Amylin, said the results support Byetta as an option for patients whose diabetes isn't controlled by metformin alone.
The study was started when Lilly and Amylin had an alliance to co-develop and co-market Byetta and a newer drug, Bydureon. However, the companies disclosed last year they would terminate the alliance in a transition through the end of 2013.
Write to Peter Loftus at [email protected]