In order to begin phase III trials, a sponsor needed to complete the phase II study of its intramuscular injection therapy for patients who had diabetic foot ulcers with and without peripheral arterial disease. The plan was to randomize 133 dosed patients over an enrollment period of 26 months.
A leading company in diabetes began phase III studies with the goal of expanding its portfolio with a next-generation basal insulin analog.
This was a critical phase III trial designed to be the most important study in this sponsor’s upcoming FDA submission for an innovative new Type 2 diabetes treatment.
This sponsor was in a crucial race in the diabetes space as it began phase III clinical trials for a new class of drug for type 2 diabetes.
They were also rolling into a crowded field of companies developing competitive compounds. The competition was stiff, but the race was worth winning. If their drug was approved, it could capture a major share of a market that was projected to nearly double to $50 billion by 2022.
The sponsor began a fierce race in the diabetes space with its phase III clinical trials for a new class of drug for type 2 diabetes. The competition was stiff, but the race was worth winning. If approved, sales were projected to hit $1.5 billion by 2018 in a market for type 2 diabetes drugs that will nearly double to $50 billion by 2022.
This seven-year outcomes study is critical to the success of a compound that is expected to build on the sponsor’s leadership position in diabetes care. Because of the study’s importance, as well as the costs associated with this multiyear program, keeping enrollment and study timelines on track was of paramount importance to the sponsor.
Acurian has the most experience in the industry.
We’ve worked in successful trials ranging from diabetic nephropathy to diabetic neuropathy, with diabetics taking specific medications, to diabetics who must have had a CV event.
Acurian has recruited and enrolled thousands of patients for more than 60 pharmaceutical and biotech companies representing over 4,500 research sites.