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New Studies Demonstrate Long-Term Efficacy of ACTOS®, Stability of TZD Therapy

June 14, 2003
Number one prescribed thiazolidinedione improves glycemic control, insulin sensitivity in type 2 diabetes, and exhibits a favorable effect on lipids

NEW ORLEANS, June 14, 2003 – 10 a.m. CST – New data released today confirm ACTOS® (pioglitazone HCl), used as monotherapy or in combination with metformin, sustains improvements in blood glucose levels and estimates of insulin sensitivity over the long term (52 weeks). Data also showed improvements in triglyceride and HDL-C levels in people with type 2 diabetes.

Results of two studies, GLAC, conducted by Eli Lilly and Company, and QUARTET 410, conducted by Takeda Europe R&D Centre Limited, were presented at the American Diabetes Association’s 63rd Annual Scientific Sessions in New Orleans. These data further support the long-term efficacy of ACTOS, the number one prescribed drug in the thiazolidinedione (TZD) class. TZDs have a unique mechanism of action to reduce insulin resistance.

“When TZDs entered the market, they greatly expanded diabetes treatments, offering a new option for managing type 2 diabetes by increasing the body’s sensitivity to insulin,” said Mehmood Khan, M.D., vice president of medical and scientific affairs for Takeda Pharmaceuticals North America, Inc (TPNA). “We are encouraged by these studies to see that the benefits of ACTOS, improved blood glucose control and favorable impact on triglyceride and HDL-C levels, can be maintained in the long run.”

Study Design & Results: GLAC
The GLAC study was a double-blind, multi-centered trial conducted in the Nordic countries that compared the effects of pioglitazone and glibenclamide, a sulfonylurea prescribed in the U.S. under the name of glyburide. The trial looked at long-term impact of the two treatments on insulin sensitivity, as well as glycemic control and lipid levels, in people with type 2 diabetes who had A1C (a measure of average blood glucose levels over a 90-120 day period) levels of 7.5 – 11 percent. Study participants were randomized to receive titrated doses of either ACTOS or glibenclamide.

The results reinforced the long-term effects of ACTOS on glucose control and insulin sensitivity. Insulin sensitivity in the studies was estimated using the homeostatic model assessment (HOMA) scale. Both ACTOS and glibenclamide had similar effects on lowering A1C levels.

The findings also showed that study participants in the ACTOS group achieved significant improvements in insulin sensitivity, HDL-C (“good”) cholesterol levels and triglyceride levels. Average insulin sensitivity was increased 17 percent from baseline. Results also showed a 0.21 mmol/l (8 mg/dl) increase in HDL-C from baseline, while triglyceride levels decreased by 0.36 mM/L (32.1 mg/dl) from baseline. In the glibenclamide group, however, none of these values reached statistical significance.

Study Design & Results: QUARTET 410
The second trial, conducted in Europe and Australia, was a parallel group, comparative trial that evaluated the long-term effects of ACTOS on glycemic control when combined with metformin. The 52-week study included 630 people with poorly controlled type 2 diabetes, as evidenced by A1C levels of 7.5 – 11.0 percent. Participants were randomized to receive ACTOS or gliclazide (a sulfonylurea used in Europe) with metformin.

Although overall findings did not reveal significant differences between the study groups, ACTOS sustained improvements in glycemic control, as well as insulin sensitivity throughout the 52 weeks of the study, indicating that ACTOS is effective and well tolerated when used in combination therapy, and provides patients with longer-term improvements in blood glucose control. The gliclazide/metformin arm showed signs of treatment deterioration beginning in week 24 of the study.

Furthermore, fasting insulin levels were significantly reduced in the ACTOS/metformin arm (3.5 micro units per ml versus 1.1 micro units per ml), suggesting that the ongoing glycemic control was impacted by reductions in insulin resistance and improved insulin activity.

ACTOS is an oral treatment for type 2 diabetes belonging to the thiazolidinedione class of drugs. It is known as an “insulin sensitizer” because it directly targets insulin resistance, a condition where the body does not produce enough insulin or does not effectively use the insulin it produces. It is taken once daily as an adjunct to diet and exercise, and is approved for use as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.

Additional Information
ACTOS is not for everyone. ACTOS can cause fluid retention or swelling, which may lead to or worsen heart failure, so tell your doctor if you have a history of these conditions. Talk to your doctor immediately if you experience rapid weight gain, swelling, or shortness of breath while taking ACTOS. If you have moderate to severe heart failure, ACTOS is not recommended. Also, your doctor should perform a blood test to check for serious liver problems or active liver disease before you start ACTOS and regularly thereafter. Do not take ACTOS if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, anorexia, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS because it could increase your chance of becoming pregnant.

Some people taking ACTOS may experience cold and flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. Occasionally, blood sugar levels increased during clinical trials. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar.

Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly-owned subsidiary of Takeda Chemical Industries, Ltd. (Osaka, Japan). Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the industry’s leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

Eli Lilly and Company
Eli Lilly and Company, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.

ACTOS is a registered trademark of Takeda Chemical Industries, Ltd. and used under license by Takeda Pharmaceuticals North America, Inc. and Eli Lilly and Company.

Please visit the ACTOS Web site at www.actos.com for complete Prescribing Information. For company information, visit Takeda Pharmaceuticals North America’s Web site at www.tpna.com .


Jocelyn Gerst

Rosy McGillan
Manning Selvage & Lee

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