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duetact

Duetact™ (pioglitazone HCl and glimepiride), pronounced “duet act,” is available by prescription across the United States for the treatment of type 2 diabetes. It was approved by the U.S. Food and Drug Administration in July 2006, making it the fourth product approval for Takeda in the 12 months from June 2005 to June 2006.

To offer physicians greater flexibility in treating their patients’ needs, duetact is available in two commonly used dosages of pioglitazone and glimepiride to be taken once daily — 30 mg/2 mg and 30 mg/4 mg.^1,2

Duetact combines ACTOS� (pioglitazone HCl) and glimepiride, two widely used diabetes medications with complementary actions, in a single tablet. ACTOS directly targets insulin resistance,³ a condition where the body does not efficiently use the insulin it produces;⁴ and glimepiride, a sulfonylurea, acts primarily by increasing the amount of insulin produced by the pancreas.^5,6 These medications work in combination to help patients with type 2 diabetes achieve and sustain blood glucose management.⁷

According to the American Diabetes Association, diabetes affects more than 20 million people in the U.S., and type 2 diabetes is the most common form of the disease. Both ACTOS and glimepiride are widely used medications in the treatment of type 2 diabetes, and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as diabetic patients are often prescribed multiple medications to help manage the disease.

Duetact, along with diet and exercise, helps improve blood sugar control in type 2 diabetes. Duetact is a combination of two drugs – pioglitazone hydrochloride and glimepiride.

Duetact may cause low blood sugar. Lightheadedness, dizziness, shakiness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.

Duetact may cause fluid retention or swelling, which could lead to or worsen heart failure, so you should tell your doctor if you have a history of these conditions. If you experience an unusually rapid increase in weight, swelling, or shortness of breath while taking duetact, talk to your doctor immediately. Duetact is not recommended for patients with moderate to severe heart failure.

Duetact is not recommended for patients with liver disease. Blood tests should be used to check for liver problems before starting and while taking duetact. Tell your doctor if you have liver disease, or if you experience unexplained tiredness, loss of appetite, stomach problems, dark urine, or yellowing of skin while taking duetact.

If you are nursing, do not take duetact. If you are pregnant or thinking about becoming pregnant, talk to your doctor before taking duetact. Duetact may increase your risk of becoming pregnant.

Some people in clinical trials experienced upper respiratory infections, weight gain, edema (swelling), hypoglycemia, and headache while taking the combination of drugs in duetact.

Your doctor should check your eyes regularly. Very rarely, some patients have experienced vision changes while taking pioglitazone, a component of duetact.

For Complete Prescribing Information for duetact or ACTOS, visit www.actos.com.

¹ DUETACT Prescribing Information. Last updated July 2006.
² DUETACT Prescribing Information. Last updated July 2006.
³ DUETACT Prescribing Information. Last updated July 2006.
⁴ American Heart Association. Metabolic Syndrome page. Available at: www.americanheart.org/presenter.jhtml?identifier=4756. Last accessed: October 2, 2006.
⁵ DUETACT Prescribing Information. Last updated July 2006.
⁶ DUETACT Prescribing Information. Last updated July 2006.
⁷ DUETACT Prescribing Information. Last updated July 2006.
⁸ American Diabetes Association. All About Diabetes. Available at: www.diabetes.org/about-diabetes.jsp. Last accessed: October 2, 2006.
⁹ American Diabetes Association. All About Diabetes. Available at: www.diabetes.org/about-diabetes.jsp. Last accessed: October 2, 2006.

Clinical trials are research studies conducted on new drugs or treatments in the pharmaceutical industry to test if they are safe and effective for patients. A clinical trial seeks to answer questions and find solutions to provide patients the safest, best treatment for a disease or illness.

Clinical trials depend on people who volunteer to try a new drug or treatment. In some cases, a drug has not yet been approved by the Food and Drug Administration (FDA) to be sold in the United States. Or, the drug has been approved, but it is being tested for a different treatment or additional information.

There are four different "phases" of clinical development:

Phase 1: This type of trial involves a small group of people (20-80), and it is the first time a drug is tested in people. Researchers study whether the drug is safe and identify side effects and safe dosage amounts. This phase usually includes healthy volunteer subjects.
Phase 2: This type of trial involves more people (100-300) than a Phase I trial, and it is typically is the first time the drug is tested in a patient population for which the drug is being developed. The primary purpose for this type of trial is to assess the drug’s effectiveness in the patient population for which it is intended. Researchers continue to study the drug’s safety
Phase 3: During this phase of clinical development, trials usually involve a large group of people (1,000-3,000). Researchers evaluate how the patients are reacting to the drug – evaluating whether the drug is helping treat the patient as it should, monitoring additional side effects, comparing it to commonly used treatments and continuing to study ways for the drug to be used safely
Phase 4: Commonly called post-marketing studies, this type of trial continues to focus on the drug’s safety, effectiveness and the best way the drug should be used.

For more information please view:

Glossary of Clinical Trials
Clinical Trials Frequently Asked Questions