Completed Studies

Completed Studies

Metformin DR was designed to minimize systemic exposure while targeting the lower bowel to stimulate L cells, which in turn produce glucoregulatory hormones such as GLP‑1. Clinical studies using Metformin DR have demonstrated the following:

Metformin DR provided approximately 50% of the systemic exposure compared to equivalent doses of Metformin IR or XR (LCRM103)

Metformin DR 1000 mg stimulated production of GLP‑1 and PYY to the same extent as Metformin IR 2000 mg (LCPOC10)

The effect on fasting and postprandial plasma glucose of Metformin DR 1000 mg was equivalent to that with Metformin IR 2000 mg (LCPOC10)

Once‑daily dosing in the morning with Metformin DR provided the same glucose lowering effect as twice‑daily dosing, with equal or lower systemic exposure (LCRM104)

Three to four months of dosing with Metformin DR resulted in clinically relevant glucose-lowering efficacy compared with currently available metformin formulations but with significantly lower systemic exposure (LCRM105 and LCRM112)

Metformin DR 1000 mg resulted in substantially lower systemic exposure compared to Metformin XR 1000 mg in patients with moderate or severe renal impairment (LCRM101)

Pharmacokinetic modeling showed that Metformin DR exposure in moderate and severe renal impairment is not higher than that with currently available metformin in normal renal function or mild renal impairment, i.e., as currently labeled