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| |  Dapagliflozin Beneficial in Type 2 Diabetes Regardless of Disease Stage or Medication Regimen: Presented at IDF By Brian Hoyle MONTREAL -- October 21, 2009 -- Oral administration of the recently developed drug dapagliflozin is beneficial in the treatment of type 2 diabetes, regardless of the stage of disease and background medication, according to a study presented here at the 20th World Diabetes Congress of the International Diabetes Federation (IDF). Of patients with type 2 diabetes, 47% require an oral antidiabetic agent such as dapagliflozin, according to the Third National Health and Nutritional Examination Survey. Dapagliflozin blocks kidney-related reabsorption of glucose by the selective inhibition of sodium-glucose transporter protein 2, enabling excess glucose to be excreted in the urine. A recently published study reported the benefits of dapagliflozin on levels of glycosylated haemoglobin (Hb A1C), fasting plasma glucose, and postprandial plasma glucose in treatment-naïve patients with type 2 diabetes.(1) James List, MD, PhD, Bristol-Myers Squibb, Global Clinical Research Center, Princeton, New Jersey, presented the results, on October 20, of a study undertaken to more conclusively establish the value of the newly developed drug. Three double-blind, placebo-controlled trials were carried out with 1,006 patients with type 2 diabetes who were characterised by inadequate glycaemic control. The patients were at different stages of disease, as reflected by the absence of drug treatment, use of metformin, and use of insulin plus insulin sensitisers. One trial was a 12-week study involving 389 drug-naïve patients (early stage; mean diabetes duration 1.6-2.5 years) who were randomised to receive placebo; dapagliflozin 2.5, 5, 10, 20, or 50 mg; or metformin 750 mg titrated to 1,500 mg. The second trial was a 24-week study in which 546 patients (midstage; duration 5.8-6.4 years) already receiving 1,500 mg metformin were randomised to also receive placebo or dapagliflozin 2.5, 5, or 10 mg. The final trial was a 12-week study in which 71 patients (late stage; duration 11.3-13.8 years) receiving insulin 50 U/day along with insulin sensitiser (metformin and/or thiazolidinediones) were continued on the same dose of insulin and a 50% reduced dose of the sensitiser and randomised to receive placebo or dapagliflozin 10 or 20 mg. Hb A1C, fasting plasma glucose, and body weight were measured for each patient. The change from baseline values of each parameter progressively decreased in a dapagliflozin-concentration-dependent manner in all 3 trials (except for Hb A1C in the drug-naïve trial, where change from baseline for dapagliflozin 20 mg was less than the change produced by 10 and 50 mg), indicating dapagliflozin’s benefit in type 2 diabetes, regardless of disease stage or medication regimen. Participants in the trials experienced similar rates of adverse events and serious adverse events; no deaths occurred. “Adverse events were generally well balanced, with no reports of significant hypoglycaemia,” said Dr. List. Although dapagliflozin did not appear to influence the occurrence of urinary tract infections, genital infections were noted more in women taking the drug. Use of the 10-mg dose appeared to minimise occurrence of infections without compromising the beneficial effects, according to Dr. List. The researchers concluded that dapagliflozin can be beneficial independent of insulin in treating type 2 diabetes in patients with early-stage to midstage disease requiring regular use of metformin and those with late-stage disease requiring insulin-based therapy. AstraZeneca and Bristol-Myers Squibb, who jointly developed dapagliflozin, plan to file for US Food and Drug Administration approval for dapagliflozin as therapy for type 2 diabetes in late 2010/early 2011. Funding for this study was provided by Bristol-Myers Squibb. 1. Wilding JPH et al. Diabetes Care. 2009;32:1656-1662. [Presentation title: Efficacy of Dapagliflozin in Three Populations of Patients on Different Treatment Regimens for Various Stages of T2DM. Abstract D-0765]
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