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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