TPNA - Actos

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actoplus met

ACTOplus met™ (pioglitazone HCl and metformin HCl) was added to Takeda's ACTOS^� (pioglitazone HCl) family of products after the U.S. Food and Drug Administration approved it for the treatment of type 2 diabetes in 2005.

ACTOplus met combines ACTOS and metformin, two widely used diabetes medications, in a single tablet. ACTOS directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces, and metformin acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.

Since most people with type 2 diabetes take multiple therapies to manage their glucose levels, Takeda believes this combination pill will offer an effective, convenient new treatment option for patients.

ACTOplus met is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and metformin or whose diabetes is not adequately controlled with metformin alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control.

ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. ACTOS may be used alone or in combination with metformin, sulfonylureas, or insulin.

A small number of people who have taken metformin, a component of ACTOplus met, have developed a rare, serious condition called lactic acidosis. Lactic acidosis, a buildup of lactic acid in the blood, can be fatal in about half the cases. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met should not be used in people with kidney disease or in people 80 years of age and older whose kidneys do not work properly. ACTOplus met should not be taken by people with metabolic acidosis or with hypersensitivity to pioglitazone, metformin or any other component of ACTOplus met. ACTOplus met should not be taken by people who drink excessive amounts of alcohol. ACTOplus met should be discontinued in patients with severe infection or in patients undergoing x-ray studies using intravenous contrast dye. Individuals should talk to their doctors before discontinuing any medications.

ACTOS and ACTOplus met can cause fluid retention (swelling) that may lead to or worsen heart failure; individuals should talk to their doctors if they have a history of these conditions. Individuals should also talk to their doctor immediately if they experience rapid weight gain, fluid retention, or shortness of breath while taking either drug. ACTOS or ACTOplus met is not recommended for individuals with moderate to severe heart failure. Doctors should perform a blood test to check for liver problems before starting patients on ACTOS or ACTOplus met and periodically thereafter. Individuals with active liver disease should not take ACTOS or ACTOplus met.

Patients who experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin after using ACTOS or ACTOplus met should talk to their doctor immediately. Those of childbearing age, should talk to their doctor before taking ACTOS or ACTOplus met, as it could increase their chance of becoming pregnant.

ACTOS or ACTOplus met should not be used in patients with type 1 diabetes.

For complete prescribing information for ACTOS or ACTOplus met, please visit www.actos.com.

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