New data showed type 2 diabetes patients experienced greater blood sugar reductions

October 15, 2009

DEERFIELD, Ill., October 14, 2009 - A study, published online in the journal Current Medical Research and Opinion, showed that a greater percentage of patients with type 2 diabetes treated with the fixed-dose combination ACTOplus met® (pioglitazone HCl and metformin HCl) as initial therapy reached the study goal of hemoglobin A1c (HbA1c) of ≤7 percent compared to either component alone. Safety and tolerability of ACTOplus met therapy were evaluated by rate of drug discontinuation and treatment-emergent adverse events.

"Diabetes is a progressive and chronic condition, which requires continued monitoring by a patient and physician. In addition to diet and exercise, patients often need to take multiple medications to help them manage their glucose control," said Robert Spanheimer, M.D., vice president of medical and scientific affairs, Takeda Pharmaceuticals North America, Inc. "We are pleased to see that this study was successful in meeting its intended endpoints. A greater number of patients reached the blood sugar target of less than 7 percent, as recommended by the American Diabetes Association, using combination therapy as initial treatment compared with either single treatment alone."

Upon completion of the study, all treatment groups achieved statistically significant HbA1c reductions (p<0.001) from a baseline HbA1c of 8.7, and the greatest decrease was observed in patients treated with ACTOplus met (15 mg/850 mg twice daily) (-1.83 percent versus 0.99 percent and 0.96 percent with ACTOS® (pioglitazone HCl) (15 mg twice daily) or metformin (850 mg twice daily), respectively). The endpoint responder rates were higher in the ACTOplus met group, with 64 percent of patients reaching HbA1c goal of ≤7 percent compared to ACTOS (46 percent) or metformin (39 percent) alone.

The overall treatment-emergent adverse events were 50.7 percent for the ACTOplus met group; 52.1 percent for the ACTOS group; and 53.1 percent for the metformin group. These adverse events led to discontinuation from the study in 5.5 percent, 7.9 percent, and 7.2 percent of patients respectively. Adverse events that occurred more frequently in the ACTOplus met group with an incidence of >3 percent included: headache at 5.5 percent, pharyngitis and nasopharyngitis each at 4 percent, and dizziness and insomnia each at 3 percent. The hypoglycemic event rates were 1.0 percent for the ACTOplus met group; 0.5 percent for the ACTOS group; and 1.4 percent for the metformin group. There was change in weight from baseline in all groups: 0.69kg in the ACTOplus met group, 1.64kg in the ACTOS group, and -1.28kg in the metformin group. The secondary endpoints of the study included change from baseline in fasting plasma glucose (FPG), fasting insulin and homeostatic model assessment-insulin resistance (HOMA-IR), a method used to measure insulin resistance. The study showed significantly greater FPG lowering in the ACTOplus met group (p<0.01) compared with ACTOS monotherapy or metformin monotherapy; and statistically significant reductions in insulin resistance were observed following treatment with ACTOplus met compared to metformin.

Study Design This study was a 24-week, multicenter, randomized, double-blind, parallel-group study comparing ACTOplus met (N=201; 15 mg/850 mg twice daily) versus ACTOS (N=190; 15 mg twice daily) and metformin alone (N=209; 850 mg twice daily), in the initial treatment of patients with type 2 diabetes. Patients at least 18 years of age with type 2 diabetes were eligible for the study if they had a baseline HbA1c ≥7.5 percent but ≤10.0 percent, and had not received treatment with antidiabetic medication in the 12 weeks prior to Screening other than short-term use of ≤15 days. The primary endpoints of the study were to compare the change from baseline in HbA1c for ACTOplus met therapy with ACTOS monotherapy and metformin monotherapy. The secondary endpoints were change from baseline in fasting insulin, FPG and HOMA, and the safety and tolerability between ACTOplus met and the individual components.

Indications and Usage ACTOplus met is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOplus met is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis. ACTOplus met has not been studied in children and is not recommended for children under the age of 18.

Important Safety Information ACTOplus met is not for everyone. Certain patients with heart failure should not start taking ACTOplus met. ACTOplus met can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, unusual tiredness, or slow heartbeat.

Metformin, one of the medicines in ACTOplus met, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. 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 or older whose kidneys do not work properly.

ACTOplus met should not be taken by people with metabolic acidosis or with hypersensitivity to ACTOS, metformin, or any other component of ACTOplus met. ACTOplus met should not be taken by people who drink excessive amounts of alcohol. Patients should talk to their doctor if they are going to have an X-ray procedure using injectable dye.

Patients should not take ACTOplus met if they have active liver disease. A doctor should perform a blood test to check for liver problems before patients start ACTOplus met and periodically thereafter. Patients should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If a patient is of childbearing age, they should talk to their doctor before taking ACTOplus met, as it could increase their chance of becoming pregnant. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

Patients with diabetes should have regular eye exams. If they experience vision problems, consult a doctor immediately. Some patients have experienced visual changes while taking ACTOplus met. Some people, particularly women, are at higher risk of having bone fractures while taking pioglitazone. Other side effects may include cold-like symptoms, diarrhea, nausea, headache, urinary tract infection, sinus infection, dizziness, swelling in the lower limbs, anemia, and weight gain.

For Complete Prescribing Information and boxed warnings, please visit www.tpna.com.

About ACTOS® (pioglitazone HCl) ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis. ACTOS has not been studied in children and is not recommended for children under the age of 18. ACTOS may be taken alone or with a sulfonylurea, metformin, or insulin.

Important Safety Information ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure.

Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness.

ACTOS should not be taken if patients have active liver disease. A doctor should perform a blood test to check for liver problems before treatment with ACTOS is started and periodically thereafter. Patients should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.

If a patient is of childbearing age, they should talk to their doctor before taking ACTOS, as it could increase their chance of becoming pregnant. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain. ACTOS may cause low blood sugar when taken in combination with insulin or sulfonylureas. Lightheadedness, shakiness, dizziness, or hunger, may mean that a patient's blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them.

Patients with diabetes should have regular eye exams. If a patient experiences vision problems, they should consult their doctor immediately. Some patients have experienced visual changes while taking ACTOS. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. Other side effects may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.
-end-
Please visit the Takeda Pharmaceuticals North America, Inc. Web site at www.tpna.com for Complete Prescribing Information, including warning about heart failure and Medication Guide.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com.

Takeda Pharmaceuticals North America

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