Lilly fortifies its Trulicity case with new Lantus-beating combo data

Eli Lilly & Co. rolled out its weekly GLP-1 drug Trulicity in late 2014, looking to challenge Novo Nordisk’s ($NVO) daily Victoza, which had dominated that market for years.

But Lilly ($LLY) hasn’t been resting on its weekly dosing alone. After all, it’s also up against GlaxoSmithKline’s ($GSK) Tanzeum and AstraZeneca’s ($AZN) Bydureon, both dosed at the same frequency. It’s been racking up new Trulicity data in a variety of patient groups to build a broader case for the med.

Case in point: The AWARD-9 trial presented on Sunday at the American Diabetes Association’s Scientific Sessions. The study tested Trulicity alongside Sanofi’s (4SNY) Lantus (insulin glargine), and the combo beat Lantus alone at every measure.

The new data is important “because it adds to the dataset on Trulicity and how it can be used in a clinical setting,” David Kendall, Lilly’s VP of medical affairs, told FiercePharma at the meeting. “Even patients who’ve progressed to insulin therapy can still benefit” from the drug.

The Trulicity-Lantus pair delivered A1C reductions of 1.44%, compared with 0.67% for Type 2 diabetes patients taking Lantus and a placebo. Plus, more than two-thirds of patients taking both drugs hit their A1C goal of less than 7%, while 35% of patients in the Lantus arm did.

Fasting blood sugar dropped more in the combo arm, and after 28 weeks of treatment, patients taking Trulicity needed fewer units of Lantus to keep their glucose levels in check. Patients in the combo group also dropped weight--1.91 kg was the median measure--while those in the Lantus arm gained 0.5 kg.

On the safety side, hypoglycemia rates were similar. About one-tenth of the Trulicity patients did experience nausea and/or diarrhea, consistent with previous studies of the drug. The 300 patients enrolled the study had been unable to hit their blood sugar targets on Lantus alone beforehand.

Trulicity is part of a growing armamentarium of diabetes drugs at Lilly. It sells a daily DPP-4 med, Tradjenta, and a metformin combo therapy, Jentadueto. The company has the SGLT2 field covered with Jardiance and two combo meds, Synjardy and Glyxambi, developed in partnership with Boehringer Ingelheim. Its insulin range--which includes the staples Humalog and Humulin--recently got a boost from Basaglar, a Lantus biosimilar developed with Boehringer. Basaglar is on sale in Europe but won’t launch in the U.S. till December.

“We’ve now launched therapies across a broad range of therapeutic classes,” Kendall pointed out. “We’re excited to be able to participate across the spectrum of treatments because we see the importance that range is to treating diabetes.”

- see the Lilly release

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