The FINANCIAL — Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced on September 20 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 hypoglycemia 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 hypoglycemia 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 Comparatorsi “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 percent.
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
Hypoglycemia 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)
Hypoglycemic event rates (any) were higher for Lantus versus OADs (p<0.001), although rates of severe hypoglycemia were similar between the two groups.
Significant Improvement in A1C Found Independent of Baseline Treatment Regimenii
“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 hypoglycemia versus those taking two OADs (p=0.0009)
Patients given Lantus who were taking only metformin had lower rates of hypoglycemia than those taking sulfonylurea or metformin plus sulfonylurea (p<0.0001) despite higher insulin doses (53 versus 37.5 versus 38.8 U)
Important Safety Information for Lantus
Do not take Lantus if you are allergic to insulin or any of the inactive ingredients in Lantus.
You must test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix Lantus with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus must only be used if the solution is clear and colorless with no particles visible. Do not share needles, insulin pens or syringes with others.
The most common side effect of insulin, including Lantus, is low blood sugar (hypoglycemia), which may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may cause unconsciousness, seizures, or death. Other possible side effects may include injection site reactions, including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening. Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works. Before starting Lantus, tell your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or
planning to become pregnant, or are breast-feeding or planning to breast-feed.
Indications and Usage
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. Do not use Lantus to treat diabetic ketoacidosis.
Lantus SoloSTAR is a disposable prefilled insulin pen.
