Duetact

Pioglitazone and glimepiride tablets
TAKEDA
Thiazolidinedione/sulfonylurea combination tablets approved for the management of type 2 diabetes

The combination of pioglitazone and glimepiride was approved on July 28, 2006, as an adjunct to diet and exercise as a once-daily combination therapy to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and a sulfonylurea or whose diabetes is not adequately controlled with a sulfonylurea alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control.

Efficacy. Although no clinical efficacy studies have been conducted with the pioglitazone/glimepiride combination, the efficacy and safety of the separate components have been previously established. Specifically, the coadministration of pioglitazone and a sulfonylurea, including glimepiride, has been evaluated for safety and efficacy in 2 clinical studies. These studies established the added benefit derived by adding pioglitazone to the therapeutic regimen of patients who have inadequate glycemic control on sulfonylurea therapy alone. In the first study, the addition of pioglitazone 15 mg or 30 mg once daily to treatment with a sulfonylurea after 16 weeks significantly reduced mean hemoglobin A_1c (HbA_1c) by 0.88% and 1.28% and the mean fasting plasma glucose (FPG) by 39.4 mg/dL and 57.9 mg/dL, respectively, from that observed with sulfonylurea treatment alone. In the second study, the addition of pioglitazone 30 mg or 45 mg once daily to treatment with a sulfonylurea significantly reduced mean HbA_1c from baseline at 24 weeks by 1.55% and 1.67% and the mean FPG by 51.5 mg/dL and 56.1 mg/dL, respectively, from that observed with sulfonylurea treatment alone. The bioequivalence of the pioglitazone/glimepiride combination tablet with coadministered pioglitazone and glimepiride tablets was demonstrated at the 30-mg/2-mg and 30-mg/4-mg dosage strengths.

Dosing. The starting dose of the pioglitazone/glimepiride combination tablet should be based on the patient's current regimen of pioglitazone and/or sulfonylurea. Patients who may be more sensitive to antihyperglycemic drugs should be monitored carefully during dose adjustment. For patients currently on glimepiride monotherapy, the pioglitazone/glimepiride combination may be initiated at either the 30-mg/2-mg or 30-mg/4-mg tablet strengths, administered once daily, and adjusted after assessing adequacy of therapeutic response. For patients currently on pioglitazone monotherapy, the pioglitazone/glimepiride combination may be initiated at the 30-mg/2-mg tablet strength, administered once daily, and adjusted after assessing adequacy of therapeutic response. Patients switching from combination therapy of pioglitazone plus glimepiride as separated tablets may be started on either the 30-mg/2-mg or 30-mg/4-mg tablet strengths, based on the dose of pioglitazone and glimepiride already being taken. Patients who are not controlled with 15 mg of pioglitazone in combination with glimepiride should be carefully monitored when switched to the pioglitazone/glimepiride combination tablet.