Sanofi (SNY) Says Lantus Not Statistically Significant on CV vs. Standard

June 14, 2012 2:04 PM EDT Send to a Friend
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Sanofi (NYSE: SNY) presented results from the landmark ORIGIN trial (Outcome Reduction with Initial Glargine Intervention) at the American Diabetes Association 72nd Scientific sessions. The key findings showed that, compared to standard care, Lantus (insulin glargine [rDNA] injection) had no statistically significant positive or negative impact on cardiovascular (CV) outcomes versus standard care during the study period and that there was no association between insulin glargine use and increased risk of any cancer. Furthermore, the study findings, which are also published online in the New England Journal of Medicine (NEJM) 1, showed that insulin glargine delayed progression from pre-diabetes to Type 2 diabetes (T2DM).

ORIGIN was a six-year randomised 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 randomised to receive insulin glargine titrated to achieve fasting normoglycaemia. There were two coprimary composite cardiovascular outcomes. The first was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second was a composite of any of these events, a revascularisation procedure (cardiac, carotid, or peripheral), or hospitalisation for heart failure. Other adjudicated outcomes were a composite microvascular outcome, incident cases of diabetes in participants without baseline diabetes, all-cause mortality, and new or recurrent cancers.

Professor Melanie Davies, UK Principle Investigator ORIGIN and Professor of Medicine Leicester University Hospitals NHS Trust commented, “ORIGIN is an impressive study delivered by an international collaborative addressing a clinically important question. It was demonstrated, in these high risk CV patients, that the use of insulin glargine confirmed no additional benefit in terms of CV outcomes. But it demonstrated that insulin glargine was a highly effective agent in achieving and maintaining HbA1c.”

She continued, “An additional important outcome of this study is that it provides conclusive evidence in the context of this long duration clinical trial that there was no increase in cancer associated with insulin glargine.”

The study demonstrated that achieving fasting normoglycaemia did not affect CV outcomes in these participants with early dysglycaemia during the study period (first co-primary endpoint: Hazard Ratio [HR]: 1.02; 95% confidence interval [CI], 0.94 to 1.11: p = 0.63, NS; and second co-primary endpoint: HR: 1.04; 95% CI, 0.97 to 1.11: p = 0.27, NS).

Insulin glargine maintained targeted long-term glycaemic control (median fasting plasma glucose 5.2 mmol/L and HbA1c 6.2% from baseline 6.4%), which was sustained over the 6.2 years of follow-up.

There was no association between insulin glargine and increased incidence of any cancer (HR: 1.00; 95% CI, 0.88 to 1.13: p = 0.97, NS). Neither analysis of death from cancer, nor analysis of cancer at specific sites, suggested an increased risk for the users of insulin glargine.

Results showed that insulin glargine delayed progression from pre-diabetes (impaired fasting glucose/IFG or impaired glucose tolerance/IGT) to T2DM by 28% (25% progressed with insulin glargine vs. 31% with standard care; HR: 0.72; 95% CI, 0.58 to 0.91: p = 0.006). Other secondary outcomes included a composite microvascular outcome (metrics of kidney or eye disease; (HR: 0.97; 95% CI, 0.90 to 1.05: p= 0.43), and all-cause mortality (HR: 0.98; 95% CI, 0.90 to 1.08: p= 0.70).

Hypoglycaemic events were infrequent. In the insulin glargine arm, the rate of severe symptomatic hypoglycaemia was 0.01 episodes per patient-year of exposure versus 0.003 episodes per patient-year for standard care. Rates for overall symptomatic hypoglycaemia with insulin glargine were 16.7 patients with events per 100 patient-years of exposure versus 5.2 patients with events per 100 patient-years for standard care. In addition, weight gain was modest for participants in the insulin glargine arm, at an average of 3.5 pounds over the duration of the study.

ORIGIN investigated the use of insulin glargine in a population in which insulins are not typically used,2 providing new data on the potential benefits and risks of initiation of insulin glargine therapy earlier in the course of diabetes (average disease duration since diagnosis at entry in trial: 5.5 years). Of the patients on insulin glargine, 58% were free of any symptomatic hypoglycaemic episode for the entire duration of the study.


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