FDA OKs New Diabetes Drug Combo

Aug. 16, 2006 -- People who take two common  diabetes drugs will soon have a simpler treatment option.

The new drug, Duetact, will combine two existing drugs -- pioglitazone (sold as Actos) and glimepiride (sold as Amaryl) - into a once-daily pill.

The FDA yesterday announced its July 28 approval of the new drug, which is pronounced "Duet Act."

Duetact's maker, Takeda Pharmaceuticals North America, plans to make the drug available by prescription later this year, according to a Takeda news release. Takeda also makes Actos.

Duetact is to be taken once daily by mouth with the first main meal of the day.

It will come in three different strengths, each with different proportions of pioglitazone and glimepiride.

Those two drugs both lower blood sugar, but each has different active ingredients and works differently.

Pioglitazone targets insulin resistance, in which the body doesn't respond properly to insulin, a hormone that controls blood sugar. The other drug -- glimepiride -- boosts insulin production by the pancreas.

Side Effects

Possible health risks for Duetact include low blood sugar (hypoglycemia), swelling (edema), weight gain, liver problems, heart failure, and increased chance of death from heart or blood vessel problems when used as a substitute for diet modification or diet modification plus insulin.

Duetact's common side effects include cold-like symptoms, headache, weight gain, leg or foot swelling, urinary tract infection, diarrhea, nausea, arm or leg pain, and lower blood sugar.

Duetact isn't recommended for people with diabetic ketoacidosis (a life-threatening diabetes complication), or for people with moderate to severe heart failure or liver problems.

Doctors should test for liver problems before patients start taking Duetact and while they are using the drug.

Duetact also isn't recommended for pregnant women, nursing mothers, or children. Women who may become pregnant should talk to their doctors before taking the medication. Duetact may make becoming pregnant more likely, the drug's label states.

Patients taking Duetact still need a healthy diet and lifestyle.

"It is important to eat the right foods, lose weight if needed, and exercise regularly in order to manage your type 2 diabetes," says Duetact's label.

"Diet, weight loss, and exercise are the main treatment[s] for type 2 diabetes and they also help your antidiabetic medicines work better for you," the label notes.