Boehringer Ingelheim Corp. and Eli Lilly and Co. said the diabetes drug Jardiance failed to improve the exercise performance of patients with heart failure compared to placebo in two late-stage studies.
The companies were evaluating Jardiance, or empagliflozin, in adult patients with heart failure during phase 3 trials called Emperial-Reduced and Emperial-Preserved. The Reduced trial featured patients with reduced ejection fraction, or reduced blood flow from the heart during the heartbeat, while Preserved patients did not have this condition. The trials included patients with and without diabetes.
Participants received a 10-milligram daily dose of Jardiance for 12 weeks in both trials but did not achieve any significant change from baseline scores on a six-minute walk test, the primary goal of the studies.
The six-minute walk test evaluates a person's ability to exercise by measuring the distance a person can walk in the given time, the companies noted in a Dec. 13 release.
Jardiance is already approved for patients with type 2 diabetes as a once-daily tablet for lowering blood sugar. The drug is also indicated to reduce the risk of cardiovascular death in type 2 diabetes patients with known heart disease.
The U.S. Food and Drug Administration accepted a new drug application in June for a diabetes combination therapy that includes Jardiance, Lilly and Boehringer Ingelheim's Tradjenta, or linagliptin, and metformin, sold by Bristol-Myers Squibb Co. as Glucophage.
Boehringer Ingelheim and Lilly are also seeking the FDA's approval for a lower 2.5-milligram dose of Jardiance as an add on therapy to insulin in patients with type 1 diabetes. The Endocrinologic and Metabolic Drugs Advisory Committee, a panel of outside advisers to the FDA, voted 14 to 2 against approval of the medicine in November, saying the drug's benefits do not outweigh risks.
The companies said full results from the ongoing Emperial trials will be shared in 2020.