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Dapagliflozin Treatment in Patients With Inadequately Controlled Type 2 Diabetes Despite the Use of Insulin FREE

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The full report is titled “Long-Term Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Receiving High Doses of Insulin. A Randomized Trial.” It is in the 20 March 2012 issue of Annals of Internal Medicine (volume 156, pages 405-415). The authors are J.P.H. Wilding, V. Woo, N.G. Soler, A. Pahor, J. Sugg, K. Rohwedder, and S. Parikh, for the Dapagliflozin 006 Study Group.

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Ann Intern Med. 2012;156(6):I-44. doi:10.7326/0003-4819-156-6-201203200-00001
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What is the problem and what is known about it so far?

Type 2 diabetes causes an inability to properly control sugar levels in the body. Many patients with type 2 diabetes require treatment with insulin to control blood sugar levels. However, some patients continue to have poorly controlled blood sugar levels even with substantial doses of insulin. Although increasing the insulin dose may be adequate to control levels in some patients, it may be inadequate in others, resulting in potentially dangerous episodes of low blood sugar or weight gain. Failure to adequately control blood sugar level increases the health risks of diabetes.

Dapagliflozin is a drug taken by mouth that blocks the ability of the kidneys to hold on to sugar. Thus, sugar is lost in the urine. In studies of patients with type 2 diabetes who did not need insulin, dapagliflozin treatment improved control of blood sugar levels.

Why did the researchers do this particular study?

To see whether dapagliflozin can improve blood sugar levels in patients with type 2 diabetes whose levels remain poorly controlled despite high doses of insulin.

Who was studied?

808 patients with type 2 diabetes with inadequately controlled blood sugar despite already receiving insulin with or without pills by mouth.

How was the study done?

Patients were given dapagliflozin or placebo pills and continued their insulin and other medications. The researchers recorded how well the patients' blood sugar was controlled as well as whether changes in insulin dose were needed during the 24-week study and during an additional 24 weeks of observation. They also recorded whether patients gained or lost weight or had episodes of low blood sugar or other bad side effects.

What did the researchers find?

After 24 weeks, the patients who received dapagliflozin had better control of blood sugar and had lost more weight than patients who received placebo. The patients who received dapagliflozin were also receiving lower doses of insulin at the end of the trial than those who had received placebo. However, more episodes of low blood sugar occurred in patients receiving dapagliflozin than those receiving placebo. In addition, dapagliflozin causes sugar to accumulate in the urine, which raised concern that it might increase genital infections. An increase in genital infections was reported in the patients who received dapagliflozin, although these infections responded to antibiotic treatment.

What were the limitations of the study?

Because the researchers wanted to be sure that any improvements were due to dapagliflozin and not increased insulin therapy, the patients did not alter their insulin treatments as would be normally recommended to reach target blood sugar levels.

What are the implications of the study?

Dapagliflozin may be helpful for some patients with type 2 diabetes whose blood sugar remains hard to control despite insulin therapy. The long-term safety of dapagliflozin has not yet been fully established, and clinical safety studies are ongoing.





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