Sanofi-aventis announced results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden. The first pooled analysis using patient-level data from randomized clinical trials demonstrated that adding Lantus (insulin glargine [rDNA] injection) to patients with type 2 diabetes, uncontrolled on oral antidiabetic drug therapy (OADs), was associated with a greater reduction in A1C levels and lower incidence of any hypoglycaemia versus all comparators (OADs, NPH, lispro, premix).

In the second pooled analysis of clinical studies, “patients with type 2 diabetes, who used Lantus as monotherapy or added it to one baseline oral antidiabetic agent, demonstrated a greater reduction in A1C with lower risk of hypoglycaemia than those taking two OADs, with a most significant reduction when Lantus was added to metformin alone versus other OADs [sulfonylurea alone or sulfonylurea plus metformin],” said Dr Jack Leahy of the University of Vermont College of Medicine and principal investigator of one of the studies.

Better Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus All Comparators

“Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus Competitors” [presentation number 976]: This pooled analysis looked at nine clinical studies where insulin-naïve patients with type 2 diabetes uncontrolled on OADs were randomized to add Lantus (n=1,462) or comparators (OADs, NPH, lispro or premix; n=1,476) to their treatment regimen. Results showed that initiating Lantus in patients uncontrolled on OADs was associated with better efficacy and goal attainment overall versus all comparators across the A1C continuum and when compared to OADs when baseline A1C was =8.0 per cent.

Outcomes showed: A1C reductions at week 24 were greater with Lantus versus all comparators (p<0.001); Efficacy across A1C categories were similar for insulin comparators; Hypoglycaemia rates (any) were lower with Lantus versus other insulin comparators (Lantus vs. NPH, p=0.032, Lantus vs. lispro, p=<0.001, Lantus vs. premix, p=004); Hypoglycaemic event rates (any) were higher for Lantus versus OADs (p<0.001), although rates of severe hypoglycaemia were similar between the two groups.

“Clinical Outcomes after Basal Insulin Initiation Correlate with Baseline Oral Antidiabetic Drug Therapy: A Pooled Analysis of Clinical Trial Data” [presentation number 960]: This analysis included data from 11 prospective randomized controlled trials of Lantus with or without OADs in adults with type 2 diabetes. The analysis compared patients given Lantus (n=2,171) who were taking zero or one OAD at baseline (low use; 1.8% and 45.2%, respectively) with those taking two OADs (52.2%) and patients on metformin only (8.5%) with those on sulfonylurea only (36.5%) or metformin and sulfonylurea (49.9%) at baseline.

Outcomes showed: At week 24, the reduction in A1C was greatest among patients given Lantus with low baseline OAD use (0/1 OADs) (p=0.0198) and among those who were taking Lantus and metformin only (p=0.0009); Patients given Lantus with low baseline OAD use had significantly lower rates of symptomatic hypoglycaemia versus those taking two OADs (p=0.0009); Patients given Lantus who were taking only metformin had lower rates of hypoglycaemia than those taking sulfonylurea or metformin plus sulfonylurea (p<0.0001) despite higher insulin doses (53 versus 37.5 versus 38.8 U)

Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. It is estimated that approximately 285 million adults worldwide are living with the disease and this number is expected to rise to a staggering 438 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed. At the same time, according to NHANES data from 2003-2004, approximately 40 per cent of those diagnosed with diabetes did not achieve the blood sugar control target of A1C <7 per cent recommended by the ADA. The A1C test measures average blood glucose levels over the past two-to-three-month period.

Sanofi-aventis strives to be a 360 degree partner delivering innovative and integrated solutions for people living with diabetes. The company currently has insulin products, including Lantus, Apidra and Insuman (outside the US)-- Lantus and Apidra are also available as injection pens (Lantus SoloSTAR and Apidra SoloSTAR). Also available in some countries (outside the US) is ClikSTAR, a reusable insulin injection pen for Lantus or Apidra for people with type 1 or type 2 diabetes.