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FDA approves new combination product for Type 2 diabetes. On July 28, the FDA approved pioglitazone HCl (Actos) plus glimepiride 30-mg/2-mg and 30-mg/4-mg tablets (Duetact, both made by Takeda Pharmaceuticals North America, Inc) for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already receiving a combination of the 2 components or whose diabetes is not adequately controlled with a sulfonylurea alone.
The 2 active ingredients have complementary modes of action — pioglitazone directly targets insulin resistance while glimepiride acts primarily to increase the amount of insulin produced by the pancreas. According to a company news release, the "duet act" product is expected to be available later this year.
The combination tablets should be administered no more than once daily at either of the tablet strengths to avoid exceeding maximum dosages for pioglitazone (45 mg/day) and glimepiride (8 mg/day).
Starting doses should be chosen based on the patient’s current regimen of pioglitazone and/or a sulfonylurea; those currently receiving pioglitazone monotherapy should receive an initial dose of 30 mg/2 mg, which can be adjusted after assessing therapeutic response. Patients transitioning from glimepiride monotherapy to combination therapy may be initiated at either the 30-mg/2-mg or 30-mg/4-mg strength.
The FDA notes that because no exact dosage relationship exists between glimepiride and other sulfonylurea agents, patients currently receiving a different sulfonylurea alone or in combination with pioglitazone should be limited to a starting dose of 30 mg/2 mg of pioglitazone plus glimepiride.
As with other thiazolidinediones, pioglitazone is associated with a risk for fluid retention that may exacerbate or lead to heart failure. Patients receiving pioglitazone should be observed for signs and symptoms of heart failure, and therapy should be discontinued if any deterioration in cardiac status occurs. Combination therapy with pioglitazone is not recommended for patients with moderate to severe heart failure.
Because of the potential risk for pioglitazone-induced hepatotoxicity, serum alanine aminotransferase (ALT) levels should be evaluated prior to initiation of therapy and periodically thereafter at appropriate intervals. Liver function tests should also be obtained for patients with symptoms suggestive of hepatic dysfunction (eg, nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine). Patients with ALT levels at 1 to 3 times the upper limit of normal should be evaluated more frequently pending a return to normal or pretreatment values. Therapy should be discontinued if ALT levels exceed 3 times the upper limit of normal or if the patient has jaundice.
The FDA notes that use of thiazolidinediones, such as pioglitazone, can cause ovulation in some premenopausal anovulatory women, thereby increasing their risk for pregnancy. Adequate contraception is therefore recommended for women of childbearing age receiving pioglitazone/glimepiride combination therapy.
FDA Report Aug, 2006
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