P. Arias

Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial

BACKGROUND Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve glycaemia in patients with type 2 diabetes by enhancing urinary glucose excretion. We compared the efficacy and safety of canagliflozin, an SGLT2 inhibitor, with glimepiride in patients with type 2 diabetes inadequately controlled with metformin. METHODS We undertook this 52 week, randomised, double-blind, active-controlled, phase 3 non-inferiority trial at 157 centres in 19 countries between Aug 28, 2009, and Dec 21, 2011. Patients aged 18-80 years with type 2 diabetes and glycated haemoglobin A1c (HbA1c) of 7·0-9·5% on stable metformin were randomly assigned (1:1:1) by computer-generated random sequence via an interactive voice or web response system to receive canagliflozin 100 mg or 300 mg, or glimepiride (up-titrated to 6 mg or 8 mg per day) orally once daily. Patients, study investigators, and local sponsor personnel were masked to treatment. The primary endpoint was change in HbA1c from baseline to week 52, with a non-inferiority margin of 0·3% for the comparison of each canagliflozin dose with glimepiride. If non-inferiority was shown, we assessed superiority on the basis of an upper bound of the 95% CI for the difference of each canagliflozin dose versus glimepiride of less than 0·0%. Analysis was done in a modified intention-to-treat population, including all randomised patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00968812. FINDINGS 1450 of 1452 randomised patients received at least one dose of glimepiride (n=482), canagliflozin 100 mg (n=483), or canagliflozin 300 mg (n=485). For lowering of HbA1c at 52 weeks, canagliflozin 100 mg was non-inferior to glimepiride (least-squares mean difference -0·01% [95% CI -0·11 to 0·09]), and canagliflozin 300 mg was superior to glimepiride (-0·12% [-0·22 to -0·02]). 39 (8%) patients had serious adverse events in the glimepiride group versus 24 (5%) in the canagliflozin 100 mg group and 26 (5%) in the 300 mg group. In the canagliflozin 100 mg and 300 mg groups versus the glimepiride group, we recorded a greater number of genital mycotic infections (women: 26 [11%] and 34 [14%] vs five [2%]; men: 17 [7%] and 20 [8%] vs three [1%]), urinary tract infections (31 [6%] for both canagliflozin doses vs 22 [5%]), and osmotic diuresis-related events (pollakiuria: 12 [3%] for both doses vs one [<1%]; polyuria: four [<1%] for both doses vs two [<1%]). INTERPRETATION Canagliflozin provides greater HbA1c reduction than does glimepiride, and is well tolerated in patients with type 2 diabetes receiving metformin. These findings support the use of canagliflozin as a viable treatment option for patients who do not achieve sufficient glycaemic control with metformin therapy. FUNDING Janssen Research & Development, LLC.

Geometric Evaluation of Road Signs Using Radiometric Information from Laser Scanning Data

Road signs appear as one of the most important elements for safety purposes and their inspection is typically included in the road management systems. Nowadays, it is becoming more common the use of high performance vehicles to improve the efficiency of the road inspection works. They include sensors as laser scanning for geometric measurements, optical profilers for the detection of cracks on pavement, ground penetrating radar for measuring pavement thickness and video cameras for the visual reference. The road signs use reflective paints to maximize the visibility by the drivers. This coating produces a high reflected radiation in the photoelectric detector of the laser scanners, which allows establishing a simple filter for the 3D segmentation of the road sign. In this work, a number of road signs are evaluated using a laser scanner Riegl LMS Z390i. The geometrical parameters under study were the sign flatness and the tilt angle with the plane of the pavement. A Matlab algorithm is developed for all the data processing (3D segmentation and evaluation of geometric parameters). The algorithms developed open the possibility to use laser scanner retroreflectivity for segmentation purposes in the evaluation of the condition state of road signs and could increase the productivity of the inspection works.

GPR for road inspection: Georeferencing and efficient approach to data processing and visualization

GPR is a recommendable non-destructive technique for thickness measurement of pavement layers because data acquisition takes place at normal traffic speeds, making GPR a cost-effective technique. On the other hand, the large collected data, when the GPR system is mounted on a moving vehicle, is difficult to process. Given that processing is conducted by qualified practitioners, it is a key to obtain software tools that allow for accurate thickness measurements and fast processing times. In this paper, an easy to use and intuitive tool for pavement thickness measurement is presented. Exploiting the power of C++ programming language and the Qt framework advantages for developing applications with graphic interface, a simple and intuitive tool for a qualified worker is implemented in order to reduce the processing times and to give information at the earliest possible moment. Furthermore, the software provides a visualization application for the georeferencing of the field GPR data by using additional GPS (Global Positioning System) data. Given that the GPR acquisition software can connect to an external GPS for trace tagging, NMEA synchronization was used in this case. If the connection is set properly, the GPR acquisition software creates a number of files in order to get the GPR traces paired with a GGA sentence. After post-processing, all the traces are referenced to a SBET (Smooth Best Estimated Trajectory).