Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial.

Background: SAR341402 insulin aspart (SAR-Asp) is a rapid-acting insulin analog developed as an interchangeable biosimilar to the marketed insulin aspart reference product (NovoLog; NN-Asp). GEMELLI X was a randomized controlled trial to assess outcomes with a biosimilar in line with the US Food and Drug Administration requirements for designation as an interchangeable biosimilar. This report assessed whether multiple switches between SAR-Asp and NN-Asp lead to equivalent safety and efficacy compared with continuous use of NN-Asp in adults with type 1 diabetes (T1D) treated with multiple daily injections, using once-daily insulin glargine U100 (Lantus) as the basal insulin.

Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial.

Aim: To assess whether multiple switches between SAR341402 biosimilar insulin aspart (SAR-Asp) and the insulin aspart reference product (NovoLog; NN-Asp) leads to equivalent pharmacokinetic (PK) exposure compared with continuous use of NN-Asp in adults with type 1 diabetes (T1D).

Materials And Methods: This multicentre, open-label, phase 3 study randomized (1:1) 210 subjects with T1D treated with once-daily insulin glargine U100 as basal insulin to four 4-week periods of alternating multiple daily injections of SAR-Asp and NN-Asp (NN-Asp for the first 4 weeks, SAR-Asp in the last 4 weeks; switching group) versus 16 weeks of continuous NN-Asp (non-switching group). At week 16, a single dose (0.

Hyperphosphatemia in multiple myeloma due to a phosphate-binding immunoglobulin.

Hyperphosphatemia (HP) is usually seen in patients with hypoparathyroidism, renal failure, and tumor lysis. The authors described a patient with HP due to a phosphate-binding immunoglobulin (Ig). An 86-year-old woman had serum phosphate levels as high as 4.

Assessment of the predictive value of X-ray pelvimetry and biparietal diameter in cephalopelvic disproportion.

The value of X-ray pelvimetry and ultrasonic measurement of the biparietal diameter for trial of labor prognosis was assessed in 172 healthy primiparas with suspected cephalopelvic disproportion. A decision diagram which is able to correctly predict 50% of the cesarean sections without increasing the number of unnecessary cesarean sections is proposed. In addition, the study confirms the superfluity of X-ray pelvimetry in cases of high station of the fetal head at the end of pregnancy.

[Peridural analgesia during labor: comparative study of a fentanyl-marcaine combination and marcaine alone].

A randomised trial was carried out to evaluate the use of a mixture of fentanyl with marcaine in epidural analgesia. Two series of 30 patients each were studied: in the first only marcaine was given for the epidural and in the second marcaine and fentanyl mixed. Stronger and longer analgesia was obtained in the series where fentanyl was added showing that local anaesthetics can be potentiated by opiates.