Not for US Media ORLANDO, Florida, June 26, 2010 - Results from a 24-week Phase 3 clinical study demonstrated that the addition of the investigational drug dapagliflozin achieved reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c), in inadequately controlled type 2 diabetes patients who were treated with insulin (with or without oral anti-diabetes medications (OADs)), compared to placebo plus insulin (with or without OADs). The study also demonstrated that dapagliflozin achieved reductions in the secondary endpoints that evaluated the change in total body weight from baseline, change from baseline in mean daily insulin dose, and change from baseline in fasting plasma glucose (FPG). Generally, adverse events, serious adverse events and study discontinuations were similar across all treatment groups. Signs, symptoms and other reports suggestive of urinary tract and genital infections were more frequently noted in the dapagliflozin treatment arms compared to placebo and rarely led to discontinuation. Results from the 24-week study were presented at the 70th American Diabetes Association (ADA) Annual Scientific Sessions.
Not for US Media ORLANDO, Florida, June 26, 2010 - Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results from a 52-week Phase 3b study in adults with type 2 diabetes who had inadequate glycemic control on metformin therapy plus diet and exercise. This study found that the addition of ONGLYZA(TM) (saxagliptin) 5 mg to existing metformin therapy achieved the primary objective of demonstrating non-inferiority compared to the addition of titrated glipizide (sulfonylurea) to existing metformin therapy in reducing glycosylated hemoglobin levels (HbA1c). Glipizide 5 mg was titrated as required to 20 mg (mean dose 14.7 mg). The final dose in two-thirds of glipizide-treated patients was 15 mg or greater, requiring two or more dosage titrations. Additionally, the study found that treatment with ONGLYZA 5 mg plus metformin resulted in a statistically significant lower proportion of subjects reporting hypoglycemic events and statistically significant weight loss compared to titrated glipizide plus metformin. ONGLYZA 5 mg plus metformin also resulted in a significantly smaller rise per week in HbA1c from week 24 to week 52 compared to titrated glipizide plus metformin. Overall adverse events excluding hypoglycemia were reported at a similar rate between the two treatment groups. Results were presented at the 70th American Diabetes Association (ADA) Annual Scientific Sessions.
Not for US Media ORLANDO, Florida, June 26, 2010 - Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement [as measured by glycosylated hemoglobin level (HbA1c)] in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone. The study results also demonstrated that a higher number of patients were able to achieve the American Diabetes Association recommended HbA1c target of less than 7% with ONGLYZA and metformin as initial combination therapy, compared to monotherapy of either treatment at week 76. The initial combination of ONGLYZA and metformin, with or without pioglitazone rescue therapy, had similar adverse event (AE) rates compared to treatment with investigational saxagliptin or metformin alone. Results were presented at the 70th American Diabetes Association (ADA) Annual Scientific Sessions.
MUNICH, June 26, 2010 - Results from the ADVANCE study presented in a late breaking clinical trial session at the ERA-EDTA 2010 Congress provide new insights into the management of secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients. ADVANCE (A randomiseD VAscular calcificatioN study to evaluate the effects of CinacalcEt) is a randomised, controlled open label study to evaluate the effects of treatment with Mimpara(R) (cinacalcet) plus low-dose vitamin D, compared to flexible doses of vitamin D alone, on the progression of vascular and valvular calcification in dialysis patients with SHPT. A trend was observed towards slower progression of vascular calcification at all sites evaluated among patients randomised to the cinacalcet arm, though the primary endpoint did not reach statistical significance.
25 June 2010: The Danish software company Vopium has expanded its group of owners to include the international telecommunications investor Raghuvinder Kataria. The 16.5 million dollar investment secures Vopium’s international expansion.
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