Diabetes (Pediatric)

August 21, 2017

Lexicon Pharmaceuticals released results of a phase III study of sotagliflozin for type 1 diabetes. The study, known as inTandem2, was a double-blind, placebo-controlled, multicenter study of 782 patients in Europe and Israel with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured. The mean baseline A1C levels after the six-week optimization period were 7.79%, 7.74% and 7.71% for patients randomized to the placebo, 200mg and 400mg arms, respectively. The primary endpoint of the study was a change in A1C from baseline after a 24-week period of treatment. The trial had a double-blind long-term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 258 patients in the placebo arm, 261 patients in the 200mg dose arm and 263 patients in the 400mg dose arm. The overall mean placebo-adjusted A1C reduction at week 24 was 0.37% in the 200mg dose arm (p<0.001) and 0.35% in the 400mg dose arm (p<0.001). The A1C benefit achieved with sotagliflozin was sustained with statistically-significant results over the full 52-week duration of the study for both the 200mg and 400mg doses. Sotagliflozin was generally well-tolerated during the study. Across all three dose arms (placebo, 200mg, 400mg), over the full 52 weeks of treatment, the incidences of AEs were 61.2%, 68.2% and 68.8%, respectively; the incidences of SAEs were 6.6%, 10.0% and 8.0%, respectively; and discontinuations due to AEs were 3.5%, 3.8% and 6.8%, respectively. There were two deaths in the study in the placebo arm and no deaths in either sotagliflozin arm.

April 18, 2016

Novo Nordisk reported results of a phase IIIa trial of Saxenda for obesity and pre-diabetes. SCALE was a randomized, double-blind, placebo-controlled, multinational trial in adults without diabetes who have obesity, and adults without diabetes who are overweight with weight-related comorbidities. At week 160, individuals treated (n=2,254 adults) with Saxenda had lost more weight (6.1%) than those treated with placebo (1.9%) (estimated treatment difference [ETD] -4.3% [95% CI, -4.9; -3.7], P<0.0001). In addition, treatment with Saxenda achieved results beyond weight loss, including improvements in some cardiometabolic risk factors such as blood pressure and cholesterol. At week 160, participants randomized to treatment with Saxenda experienced a greater reduction in systolic blood pressure compared with placebo (ETD -2.8 mmHg [-3.8; -1.8], P<0.0001). Those treated with Saxenda also experienced greater improvements in triglycerides (ETD -6% [-9; -3], P=0.0003) and total cholesterol levels (ETD -2% [-3; 0], P=0.03) compared with placebo. Additionally, people treated with Saxenda showed a greater reduction in mean waist circumference (ETD -3.5 cm/-1.4 in [-4.2 cm/-1.7 in; -2.8 cm/-1.1 in]).