Actualizado 08/09/2008 16:41
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Saxagliptin Improved Key Measures of Glucose Control When Added to a Sulphonylurea or Thiazolidinedione in People With I

The primary endpoint of the study was the change from baseline to week 24 in A1C. The secondary endpoints of the study included changes from baseline to week 24 in FPG, PPG response, as indicated by PPG area under the curve (AUC) from 0 - 180 minutes during an oral glucose tolerance test (OGTT), and the proportion of individuals achieving the American Diabetes Association recommended A1C target of less than 7 percent.

After 24 weeks, individuals in the saxagliptin + TZD treatment arms demonstrated an adjusted mean change in A1C from baseline of -0.7 percent for saxagliptin 2.5 mg + TZD and -0.9 percent for saxagliptin 5 mg + TZD, compared with -0.3 percent for placebo + TZD (p-value less than or equal to 0.0007 for both treatment arms). A greater percentage of individuals treated with saxagliptin + TZD achieved an A1C of less than 7 percent at week 24: 42.2 percent for saxagliptin 2.5 mg + TZD and 41.8 percent for saxagliptin 5 mg + TZD, compared with 25.6 percent for placebo + TZD (p-value less than or equal to 0.0013 for both treatment arms).

Individuals treated with saxagliptin + TZD demonstrated an adjusted mean change from baseline in FPG: -14.3 mg/dL for saxagliptin 2.5 mg + TZD and -17.3 mg/dL for saxagliptin 5 mg + TZD, compared with -2.8 mg/dL for placebo + TZD (p-value less than or equal to 0.0053 for both treatment arms). Both saxagliptin + TZD treatment arms also demonstrated adjusted mean decreases from baseline in PPG, compared with placebo + TZD (p-value less than 0.0001 for both treatment arms).

One confirmed case of hypoglycemia (symptoms of hypoglycemia with a fingerstick glucose less than or equal to 50 mg/dL) was reported in the saxagliptin 2.5 mg + TZD treatment arm. There were no cases of confirmed hypoglycemia in the saxagliptin 5 mg + TZD or placebo + TZD treatment arms. Reported hypoglycemic events were: 4.1 percent for the saxagliptin 2.5 mg + TZD, 2.7 percent for saxagliptin 5 mg + TZD, and 3.8 percent for placebo + TZD.

Over 24 weeks, the incidence of adverse events was: 62.1 percent for saxagliptin 2.5 mg + TZD, 74.2 percent for saxagliptin 5 mg + TZD and 66.8 percent for placebo + TZD. The percentages of the most commonly reported (greater than or equal to 5 percent) adverse events from the saxagliptin 2.5 mg + TZD, saxagliptin 5 mg + TZD and placebo + TZD treatment arms, respectively, were: upper respiratory tract infection (7.7, 9.1, 7.1); urinary tract infection (3.6, 6.5, 6.5); nasopharyngitis (3.1, 4.8, 6.0); arthralgia or joint pain (5.6, 2.7, 2.7); headache (4.6, 5.4, 3.8); dizziness (2.6, 3.2, 5.4); peripheral oedema (3.1, 8.1, 4.3); and hypertension (5.6, 4.3, 4.9).

About saxagliptin

Saxagliptin is an investigational DPP-4 inhibitor, under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. Saxagliptin is being studied in clinical trials as a once-daily therapy to determine its efficacy and safety profile. Saxagliptin was specifically designed to be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual routes of clearance.

Saxagliptin Phase III data have previously been presented as a monotherapy and in combination with metformin, the most commonly prescribed oral anti-diabetic medication. Further Phase III data on saxagliptin as initial combination therapy with metformin will be disclosed this week. The overall clinical development programme included more than 5,000 individuals, more than 4,000 of whom were given saxagliptin.

About DPP-4 inhibitors

DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels (glucose) by increasing the body's use of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver's production of glucose.

About type 2 diabetes

Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role.(1)a Diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage.(2a)

There are two primary underlying causes associated with type 2 diabetes: the body does not produce enough insulin (insulin deficiency), or the cells ignore the insulin (insulin resistance).(2b) Symptoms of type 2 diabetes develop gradually, and their onset is not as sudden as in type 1 diabetes. Symptoms may include fatigue, frequent urination, increased thirst and hunger, weight loss, blurred vision, and slow healing of wounds or sores. Some people, however, have no symptoms.(3b)

Type 2 diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity and certain ethnicities.(3c) People with type 2 diabetes often are characterized with: insulin resistance, abdominal obesity, a sedentary lifestyle, having low HDL-C ("good") cholesterol levels and high triglyceride levels and hypertension.(3)

Type 2 diabetes accounts for approximately 90 to 95 percent of all diabetes.(3d) This equates to roughly 221 million people with type 2 diabetes globally,(4),(3d) and 21.2 million people in the United States alone.(2a),(3d)

The American Diabetes Association recommends a hemoglobin A1C measurement of less than 7 percent(5) for most people with type 2 diabetes. The International Diabetes Federation recommends an A1C of less than or equal to 6.5 percent(6) for most people with type 2 diabetes. Hemoglobin A1C is a measurement of a person's average blood glucose level during a two-to-three month period and is considered an important marker of long-term glucose control.(7) Other important markers for type 2 diabetes include fasting plasma glucose, a measure of a person's blood glucose after at least 8 hours of fasting and postprandial glucose, a measure of a person's blood glucose after a meal.

Bristol-Myers Squibb and AstraZeneca collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialise two investigational drugs for type 2 diabetes - saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

Bristol-Myers Squibb forward-looking statement

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