New data being presented at the 40th Annual Meeting of the European Association for the Study of Diabetes (EASD) show that the combination of AVANDIA (rosiglitazone maleate) and metformin enabled over 60 percent of patients to achieve the glucose target of ≤ 7 percent HbA1c and nearly 40 percent of patients to reach the more stringent goal of ≤ 6.5 percent HbA1c.* In addition, the results of this six-month, real-life study involving 11,014 patients demonstrate that AVANDIA and metformin in combination reduced patients' blood pressure.1

"These new data are exciting as they demonstrate that by using the combination of AVANDIA plus metformin physicians in daily practice can now effectively control their type 2 diabetes patients' blood sugar levels to international treatment goals," said lead investigator, Dr Christoph Rosak from the Department of Metabolic Disease, Krankenhaus Sachsenhausen, Frankfurt, Germany. “Controlling glucose levels to targets of less than 6.5 to 7 percent HbA1c has previously been challenging, particularly as conventional monotherapy fails to control blood glucose over the long-term. Our new data also show that in the population studied AVANDIA plus metformin had the extra benefit of lowering patients’ blood pressure."

Currently, only about 30 percent of people with type 2 diabetes have glucose levels below recommended targets of 6.5 to 7 percent HbA1c.2 In uncontrolled patients, chronic levels of high blood sugar can cause tissue and organ damage and can lead to serious complications such as cardiovascular disease, amputation and blindness.3 As type 2 diabetes is a progressive disease, the longer patients remain uncontrolled, the more extensive the damage and the harder it is to get the disease under control. Effective treatment of hypertension is also critically important in the management of patients with type 2 diabetes to reduce the risk of the devastating complications of the disease.4,5

AVANDIA helps to control blood sugar because it directly targets insulin resistance, an underlying cause of type 2 diabetes.6 Research has demonstrated that insulin resistance is also an independent risk factor for cardiovascular disease7 and that AVANDIA may have a positive effect on certain cardiovascular risk markers associated with type 2 diabetes such as blood pressure8 and HDL cholesterol.9 When combined with metformin, which works primarily by reducing the amount of sugar produced by the liver,10 these two drugs with complementary modes of action can help patients achieve enhanced glucose control, which in turn may slow disease progression and reduce the risk of long-term complications.11 The combination of AVANDIA plus metformin has also been shown to have a low risk of hypoglycaemia (low blood sugar), a side effect commonly associated with other conventional therapies.12

The new study presented at EASD was a pooled analysis of two large observational studies of reallife daily practice in Germany. A total of 11,014 patients received AVANDIA and metformin combination therapy for six months and achieved:1

-- an improvement in the percentage of patients reaching HbA1c levels of ≤ 7 from 13.5% at baseline to 63.7% at 6 months

-- an improvement in the percentage of patients reaching HbA1c levels of ≤ 6.5 from 5.3% at baseline to 38.8% at 6 months

-- a significant reduction of 1.3 percent in median HbA1c levels from baseline (p<0.0001) and a decrease in fasting blood glucose by 2.6 mmol/L (47 mg/dL) (p<0.0001)

-- a decrease in mean blood pressure levels from 144/85 mmHg at baseline to 137/82 mmHg (p<0.0001).

In addition, few adverse events (1.3 percent of patients) and few serious adverse events (0.4 percent

of patients) were reported. Some of the most common adverse events were oedema (0.19%), liver toxicity (0.06%) and congestive heart failure (0.04%). There was a very low incidence of hypoglycaemia in this study (0.02%).

About AVANDIA

AVANDIA is indicated in the European Union for use as monotherapy for patients who cannot take metformin (contraindication or intolerance), and in combination with metformin particularly in overweight patients, with insufficient glycaemic control despite maximal tolerated dose of metformin.

AVANDIA is also indicated for use in combination with a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea who cannot take metformin (contraindication or intolerance).

In contrast to patients taking AVANDIA as monotherapy, patients taking AVANDIA with sulphonylureas may be at increased risk for low blood sugar.

Some people may experience anaemia or weight gain with AVANDIA. AVANDIA may cause fluid retention or swelling which could lead to or worsen heart failure, so patients who experience this should tell their doctor. If patients experience an unusually rapid increase in weight, swelling or shortness of breath while taking AVANDIA, it's advised that they talk to their doctor immediately. AVANDIA is not for everyone. In Europe, AVANDIA may not be used for women who are nursing and/or pregnant or for patients with heart failure or active liver disease (identified by blood tests conducted before and during therapy).

Premenopausal, non-ovulating women are at increased risk of pregnancy following possible resumption of ovulation when taking AVANDIA and should consult their physician.

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