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Diabetes Drug LX4211 Achieves Primary Endpoint in Phase II Trial

Need for mealtime insulin reduced

Positive results have been reported from a phase II clinical trial of LX4211 (Lexicon Pharmaceuticals) in patients with type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control.

LX4211 is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2) that is designed to lower blood glucose levels through two insulin-independent mechanisms of action.

In the placebo-controlled, double-blind, 28-day study, LX4211 reduced the total daily mealtime bolus insulin dose by 32% compared with 6% for placebo (P = 0.007) while significantly improving glycemic control, with a mean hemoglobin A1c (HbA1c) reduction of 0.55% in the LX4211-treated group compared with a reduction of 0.06% in the placebo group (P = 0.002). This improvement was accompanied by significant improvement in the time spent in a glucose range of 70 to 180 mg/dL, a significant reduction in the time in the hyperglycemic range, and no increase in hypoglycemia.

Multiple measures indicated that LX4211 treatment resulted in reduced variability in blood glucose levels. Overall, LX4211 was well tolerated with no discontinuations of study medication because of adverse events.

In this phase II study, 33 patients with poorly controlled type 1 diabetes during treatment with either an insulin pump or multiple insulin injection therapy were randomly assigned to receive either a 400-mg dose of LX4211 or placebo orally once per day before breakfast for 4 weeks. Patients adjusted their insulin as needed; recorded their blood sugars; and were evaluated at the end of the study for the amount of insulin used and glycemic control, as measured by HbA1c, continuous glucose monitors, and serum blood glucose measures.

Type 1 diabetes is a serious condition affecting more than one million people in the U.S., both children and adults. It is an autoimmune disease in which a person’s pancreas stops producing insulin. The disease occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas. Insulin is a required treatment, with few additional treatment options.

The effectiveness of insulin is limited by concerns about potentially serious hypoglycemia; therefore, most patients with type 1 diabetes do not achieve their targets for glucose control. In addition, insulin therapy does not necessarily prevent the possibility of serious complications of the disease, which may include kidney failure, blindness, nerve damage, heart attack, and stroke.

As an oral agent, LX4211 is designed to delay the absorption of glucose in the gastrointestinal tract and to enhance glucose excretion in the kidney, thereby allowing glucose control to improve and insulin doses to be reduced.

Source: Lexicon Pharmaceuticals; April 14, 2014.

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