US-based pharmaceutical company Elcelyx Therapeutics has completed enrolment in its Phase llb clinical trial to evaluate metformin delayed release (DR) in patients with type 2 diabetes.
Metformin DR is a new product, which is designed to target metformin delivery to the lower small intestine, where it is minimally absorbed yet elicits its full glucose lowering effect.
The product has previously been studied in nine clinical trials, including an earlier Phase ll trial where various doses of metformin DR were compared with placebo or metformin extended release (XR) in patients with type 2 diabetes.
The primary endpoint of the multicentre, randomised, Phase llb dose-ranging study is change in HbA1c from baseline at 16 weeks compared with placebo.
The trial enrolled 571 subjects to evaluate the glycemic effects of several doses including 600mg, 900mg, 1200mg and 1500mg once daily of metformin DR, in comparison to placebo.
It also includes a single-blind comparator arm of subjects receiving 2000mg of metformin immediate release (IR) per day, given as equally divided doses of 1000mg of metformin IR twice daily.
Apart from measuring HbA1c for more than 16 weeks, the trial will also assess safety and tolerability of metformin DR.
Results of the trial are expected in the fourth quarter of this year.
The trial results will serve to further document metformin's gut mediated site of action and verify doses to be studied in Phase lll trial in patients with advanced renal disease.
Elcelyx noted that even though metformin is the preferred agent to treat type 2 diabetes, patients often discontinue it due to renal impairment and gastrointestinal intolerance.
Physicians also face various challenges with metformin use in patients with renal disease, including the need to monitor renal function status to ensure proper use.
Elcelyx Therapeutics president and CEO Dr Alain Baron said: "We are eager to confirm and extend our previous findings that metformin DR can achieve significant glucose control, while minimising systemic exposure at metformin doses that would be subtherapeutic or suboptimal using current formulations.
"This would support late-stage trials of metformin DR in patients with type two diabetes and advanced renal disease, an under-served population that is either contraindicated from using currently available metformin or can only take a suboptimal dose due to the risk of life-threatening, metformin-associated lactic acidosis.
"We believe metformin DR can fulfil a valuable therapeutic role and allow continued use of metformin as first-line and foundational therapy in patients with type two diabetes along the continuum of renal impairment."