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Sanofi Announces Results Of Origin Trial

6/11/2012 2:39 PM ET

Sanofi (SNY: Quote) 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.

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by RTT Staff Writer

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