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Phase 3 clinical success of new drugs for diabetes mellitus

Lexicon Pharmaceuticals, a wuxi Apptec partner, reported positive data from its phase 3 inTandem1 study. Previously, the company announced that both doses of sotagliflozin met the primary end point of the inTandem1 study, with data showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes in the context of optimized insulin. This time, important new findings include the benefit of sotagliflozin on body weight in patients with type 1 diabetes and improvements in systolic blood pressure (SBP) in patients with type 1 diabetic hypertension. In addition, Lexicon announced that the study met important secondary end points, including net benefit, push insulin use, fasting plasma glucose, and patient-reported results.
Using Lexicon's unique genetic approach, researchers developed sotagliflozin as the first (first-class) oral dual inhibitor of its kind, targeting sodia-glucose cotransporters type 1 and type 2 (SGLT1 and SGLT2) responsible for glucose regulation. SGLT1 is responsible for glucose absorption from the GI tract, while SGLT2 is responsible for glucose reabsorption from the kidney. In phase 2 studies, sotagliflozin has been shown to effectively improve glycemic control in patients with type 1 diabetes while reducing the need for mealtime insulin.

▲Sotagliflozin inhibits SGLT1 and SGLT2 (image source: Lexicon)
The phase 3 study, called inTandem1, was a double-blind, placebo-controlled, multicenter study in the United States and Canada involving 793 patients who were treated with insulin pumps or multiple daily injections for type 1 diabetes and entered clinical trials with A1C levels between 7.0% and 11.0%. This three-arm study evaluated two doses of sotagliflozin (200mg and 400mg) taken daily before the first meal, as compared with placebo. Before randomization, all patients underwent insulin optimization for six weeks with the aim of improving glycemic control by using insulin alone. After completion of this optimization period, patients maintained optimized insulin and were randomized to one of two doses of sotagliflozin or placebo, and their baseline and optimized A1C values were measured. After a six-week optimization period, the mean baseline A1C level at randomization was 7.6% in all three dose groups. The primary end point was the change from baseline in A1C after 24 weeks of treatment.
▲Lexicon's research product line (photo source: Lexicon official website)
In a key secondary end point, after 24 weeks of treatment, patients receiving sotagliflozin had a baseline mean weight loss of 1.6 kg in the 200mg group and 2.7 kg in the 400mg group, compared with a mean weight gain of 0.8 kg in the placebo group (p
In addition, some subgroups of patients with type 1 diabetes treated with 200mg and 400mg doses of sotagliflozin had systolic blood pressure reductions of 9.9mmHg and 11.0mmHg, respectively, compared with baseline systolic blood pressure of 130 MMHG (symptoms of hypertension) at week 12. In the placebo group, the reduction was 4.4mmHg (200mg dose, p=0.017; 400mg dose, p=0.003).
Notably, the results for each secondary end point were better than placebo, while the results for the 400mg dose were statistically significant for all six secondary end points (as were the results for the first two secondary end points for the 200mg dose).



Mr. Lonnel Coats, President and CEO of Lexicon
"Sotagliflozin's ability to improve A1C and other health measures, such as weight and blood pressure, holds promise for addressing an important need in the field of type 1 diabetes, and additional inTandem1 results announced today highlight the differentiated benefits of sotagliflozin in the treatment of type 1 diabetes." Lonnel Coats, President and Chief Executive Officer of Lexicon, said, "In the coming weeks, we look forward to the results of inTandem3 to see its' net benefit 'primary efficacy end point -- the proportion of patients with A1C measures of less than 7% and no severe hypoglycemia or DKA events. We saw favorable results on the same endpoints for inTandem1 and inTandem2, and remain confident that these data will be replicated in inTandem3. "


Reference Materials:
[1] Lexicon Pharma (LXRX) Reports Additional Positive Data From Pivotal InTandem1 Phase III Study For Sotagliflozin In Patients With Type 1 Diabetes
[2] Official website of Lexicon Pharmaceuticals

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