DUETACT is a thiazolidinedione and sulfonylurea combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and a sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone.

General

The use of antihyperglycemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia.

Dosage Recommendations

Selecting the starting dose of DUETACT should be based on the patient's current regimen of pioglitazone and/or sulfonylurea. Those patients who may be more sensitive to antihyperglycemic drugs should be monitored carefully during dose adjustment. After initiation of DUETACT, patients should be carefully monitored for adverse events related to fluid retention (see BOXED WARNING and WARNINGS, Pioglitazone hydrochloride). It is recommended that a single dose of DUETACT be administered once daily with the first main meal.

Starting dose for patients currently on glimepiride monotherapy

Based on the usual starting dose of pioglitazone (15 mg or 30 mg daily), DUETACT may be initiated at 30 mg/2 mg or 30 mg/4 mg tablet strengths once daily, and adjusted after assessing adequacy of therapeutic response.

For patients with type 2 diabetes and systolic dysfunction, see DOSAGE AND ADMINISTRATION, Special Patient Populations.

Starting dose for patients currently on pioglitazone monotherapy

Based on the usual starting doses of glimepiride (1 mg or 2 mg once daily), and pioglitazone 15 mg or 30 mg, DUETACT may be initiated at 30 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.

For patients who are not currently on glimepiride and may be more sensitive to hypoglycemia, see DOSAGE AND ADMINISTRATION, Special Patient Populations.

Starting dose for patients switching from combination therapy of pioglitazone plus glimepiride as separate tablets

DUETACT may be initiated with 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 DUETACT.

Starting dose for patients currently on a different sulfonylurea monotherapy or switching from combination therapy of pioglitazone plus a different sulfonylurea (e.g. glyburide, glipizide, chlorpropamide, tolbutamide, acetohexamide)

No exact dosage relationship exists between glimepiride and the other sulfonylurea agents. Therefore, based on the maximum starting dose of 2 mg glimepiride, DUETACT should be limited initially to a starting dose of 30 mg/2 mg once daily, and adjusted after assessing adequacy of therapeutic response.

Any change in diabetic therapy should be undertaken with care and appropriate monitoring as changes in glycemic control can occur. Patients should be observed carefully for hypoglycemia (1-2 weeks) when being transferred to DUETACT, especially from longer half-life sulfonylureas (e.g. chlorpropamide) due to potential overlapping of drug effect.

Sufficient time should be given to assess adequacy of therapeutic response. Ideally, the response to therapy should be evaluated using A1C, which is a better indicator of long-term glycemic control than FPG alone. A1C reflects glycemia over the past two to three months. In clinical use, it is recommended that patients be treated with DUETACT for a period of time adequate to evaluate change in A1C (8-12 weeks) unless glycemic control as measured by FPG deteriorates.

Special Patient Populations

DUETACT is not recommended for use in pregnancy, nursing mothers or for use in pediatric patients.

In elderly, debilitated, or malnourished patients, or in patients with renal or hepatic insufficiency, the initial dosing, dose increments, and maintenance dosage of DUETACT should be conservative to avoid hypoglycemic reactions. These patients should be started at 1 mg of glimepiride prior to prescribing DUETACT. During initiation of DUETACT therapy and any subsequent dose adjustment, patients should be observed carefully for hypoglycemia (see PRECAUTIONS, General: Glimepiride, Hypoglycemia).

Therapy with DUETACT should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT greater than 2.5 times the upper limit of normal) at start of therapy (see PRECAUTIONS, General: Pioglitazone hydrochloride, Hepatic Effects and CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency: Pioglitazone hydrochloride). Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with DUETACT and periodically thereafter (see PRECAUTIONS, General: Pioglitazone hydrochloride, Hepatic Effects and PRECAUTIONS, Laboratory Tests).

The lowest approved dose of DUETACT therapy should be prescribed to patients with type 2 diabetes and systolic dysfunction only after titration from 15 mg to 30 mg of pioglitazone has been safely tolerated. If subsequent dose adjustment is necessary, patients should be carefully monitored for weight gain, edema, or signs and symptoms of CHF exacerbation (see WARNINGS, Pioglitazone hydrochloride, Cardiac Failure and Other Cardiac Effects).

Maximum Recommended Dose

DUETACT tablets are available as a 30 mg pioglitazone plus 2 mg glimepiride or a 30 mg pioglitazone plus 4 mg glimepiride formulation for oral administration. The maximum recommended daily dose for pioglitazone is 45 mg and the maximum recommended daily dose for glimepiride is 8 mg.

DUETACT should therefore not be given more than once daily at any of the tablet strengths.

DUETACT is available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows:

30 mg/2 mg tablet: white to off-white, round, convex, uncoated tablet, debossed with 30/2 on one side and 4833G on the other, available in:

NDC 64764-302-30 Bottles of 30
NDC 64764-302-90 Bottles of 90

30 mg/4 mg tablet: white to off-white, round, convex, uncoated tablet, debossed with 30/4 on one side and 4833G on the other, available in:

NDC 64764-304-30 Bottles of 30
NDC 64764-304-90 Bottles of 90

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. July 2011

Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.