Study ResultsAt the end of 24 weeks, patients treated with dapagliflozin 10 mg added to metformin plus sulfonylurea demonstrated significantly greater improvements in glycemic control compared to those who received placebo, with a mean change from baseline in HbA1c of -0.86% (95% Confidence Interval [CI]: -1.00, -0.72) in the dapagliflozin group versus -0.17% (95% CI: -0.31, -0.02) in the placebo group (p-value < 0.0001). Additional results of the key secondary endpoints included the following:
- More patients treated with dapagliflozin (31.8%) achieved an HbA1c < 7.0% compared to patients who received placebo (11.1%) at week 24 (p-value < 0.0001).
- At week 24, patients treated with dapagliflozin showed significant improvements in adjusted mean FPG (-34.23 mg/dL; 95% CI: -40.98, -27.48) compared to patients who received placebo (-0.78 mg/dL; 95% CI: -7.56, 6.01; p-value < 0.0001).
- Patients treated with dapagliflozin experienced significant reductions in mean body weight (-2.65 kg; 95% CI: -3.16, -2.14) at week 24 compared to patients who received placebo (-0.58 kg; 95% CI: -1.09, -0.07; p-value < 0.0001).
- At week eight, patients treated with dapagliflozin had significant reductions in mean SBP (-4.04 mmHg) compared to patients who received placebo (-0.27 mmHg; p-value = 0.025).
Study DesignThis 24-week Phase III, randomized, double-blind, placebo-controlled study with an ongoing 28-week extension is designed to evaluate the efficacy and safety of dapagliflozin in patients with type 2 diabetes with inadequate glycemic control on combination therapy with metformin plus sulfonylurea. The primary endpoint is mean change in HbA1c from baseline to week 24. Secondary endpoints include mean change from baseline to week 24 in FPG and total body weight, proportion of patients achieving HbA1c levels of < 7.0% at week 24 and change in SBP from baseline to week 8. The study includes 216 adult patients with type 2 diabetes (aged ≥ 18 years) with inadequate glycemic control (HbA1c ≥ 7.0% and ≤ 10.5%) receiving metformin (≥ 1500 mg QD) and a maximum tolerated dose of sulfonylurea (at least half the maximum label dose for ≥ 8 weeks). Patients were randomized to receive dapagliflozin 10 mg (n = 108) or placebo (n = 108) for 24 weeks. About SGLT2 Inhibition The kidney plays an important role in maintaining normal glucose balance by filtering and reabsorbing glucose from circulation. SGLT2, a sodium-glucose cotransporter found predominantly in the kidney, is responsible for the majority of glucose reabsorption. In patients with type 2 diabetes, the capacity of the kidney to reabsorb glucose is increased by approximately 20%, further exacerbating the hyperglycemia associated with the disease. Selective inhibition of SGLT2 reduces the reabsorption of excess glucose and enables its removal via the urine. About Diabetes In 2012, diabetes was estimated to affect more than 370 million people worldwide. The prevalence of diabetes is projected to reach more than 550 million by 2030. Type 2 diabetes accounts for approximately 90% to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease characterized by insulin resistance and dysfunction of beta cells in the pancreas, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to further progression of the disease. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.
About the AstraZeneca/Bristol-Myers Squibb Diabetes AllianceDedicated to addressing the global burden of diabetes by advancing individualized patient care, AstraZeneca and Bristol-Myers Squibb are working in collaboration to research, develop and commercialize a versatile portfolio of innovative treatment options for diabetes and related metabolic disorders that aim to provide treatment effects beyond glucose control. Find out more about the Alliance and our commitment to meeting the needs of health care professionals and people with diabetes at www.astrazeneca.com or www.bms.com. About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews. AstraZeneca Cautionary Statement Regarding Forward-Looking Statement In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: This press release contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group. 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Nothing in this press release should be construed as a profit forecast. Bristol-Myers Squibb Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2012, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. 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