logo
Plus   Neg
Share
Email

Sanofi Announces Results Of Origin Trial

Sanofi (SNY) announced results from the landmark Origin trial or Outcome Reduction with Initial Glargine Intervention, which showed that Lantus or insulin glargine [rDNA] injection had no statistically significant positive or negative impact on cardiovascular or CV outcomes versus standard care during the study period.

The company said the results also showed that insulin glargine delayed progression from pre-diabetes to type 2 diabetes and there was no association between insulin glargine use and increased risk of any cancer.

Origin was a six-year randomized clinical trial designed to assess the effects of treatment with insulin glargine versus standard care on CV outcomes. The study involved over 12,500 participants worldwide with pre-diabetes or early type 2 diabetes mellitus and high CV risk, with 6,264 participants randomized to receive insulin glargine titrated to achieve fasting normoglycemia, Sanofi said.

The co-primary endpoints were the composite of CV death, or non-fatal myocardial infarction, or non-fatal stroke; and the composite of CV death, or non-fatal myocardial infarction, or non-fatal stroke, or revascularization procedure, or hospitalization for heart failure.

The study demonstrated that achieving fasting normoglycemia did not affect CV outcomes in these participants with early dysglycemia during the study period (first co-primary endpoint: Hazard Ratio [HR]: 1.02; p = 0.63, NS; and second co-primary endpoint: HR: 1.04; p = 0.27, NS).

The company noted that insulin glargine achieved targeted long-term glycemic control (median fasting plasma glucose 5.2 mmol/L and HbA1c 6.2%), which was sustained over the 6.2 years of follow-up.

Results showed that insulin glargine delayed progression from pre-diabetes (IFG or IGT) to type 2 diabetes mellitus by 28% (HR: 0.72; p = 0.006). Other secondary outcomes included a composite microvascular outcome (metrics of kidney or eye disease; (HR: 0.97; p = 0.43), and all-cause mortality (HR: 0.98; p = 0.70), Sanofi said.

Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and children (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose, the company noted.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Shares of General Electric Co. are rising more than 10 percent on Thursday after the industrial conglomerate said it plans to establish a new, independent company focused on building a comprehensive Industrial Internet of Things or IIoT software portfolio. In addition, longtime bearish analyst Stephen Tusa of J.P. Morgan upgraded shares of GE to neutral. Apple Inc. said Thursday that it will invest $1 billion to build a new corporate campus in North Austin that will eventually create 15,000 jobs. Further, the tech giant announced plans to establish new offices and expand to over 1,000 employees each in three cities - Seattle, San Diego and Culver City, California. In January, Apple said it will create over 20,000 jobs over the next five years. German telecom giant Deutsche Telekom, Chinese conglomerate Alibaba's Alibaba Cloud, banking giant Citi and 13 other organizations have joined Hyperledger Blockchain project, an open source collaborative effort aimed to advance cross-industry blockchain technologies. Hyperledger, a project of The Linux Foundation that started less than three years ago, is a multi-project.
Follow RTT