Brand Name: Lantus
Active Ingredient: insulin glargine (rDNA origin) injection
Indication: Treatment of adults and children with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus who require long-acting insulin for control of hyperglycemia
Company Name: Aventis Pharmaceuticals
Availability: FDA approved Lantus for marketing on April 24, 2000; may be available in late 2000
Introduction
A new form of insulin will soon be available that may make life easier for many diabetics who require daily insulin injections. Called Lantus, it is the first long-acting recombinant human insulin analog with once-daily administration and 24-hour glucose-lowering power to be approved by the FDA. Aventis Pharmaceuticals, the manufacturer of Lantus, received FDA approval for the drug on April 24, 2000.
Lantus (insulin glargine [rDNA origin] injection) is indicated for the treatment of adults and children with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus who require long-acting insulin for control of hyperglycemia. Just one injection a day provides a relatively constant concentration/time profile over a 24-hour period.
How It Works
Lantus is a recombinant human insulin analog that can be administered once daily at bedtime for people with type 1 or type 2 diabetes. The chemical structure of Lantus regulates its release from the subcutaneous tissue into circulation, providing a relatively constant profile with no pronounced peak and a glucose-lowering effect over 24 hours. The longer duration of action of Lantus is directly related to its slower rate of absorption and supports once-daily subcutaneous administration.
Insulin and its analogs lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.
Clinical Study Results
Controlled clinical trials showed that Lantus demonstrated similar levels of efficacy, with regard to metabolic control, as Neutral Protamine Hagedorn (NPH) human insulin. In clinical studies, Lantus showed a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH human insulin.
In two randomized controlled clinical studies, more than 1,100 adult patients with type 1 diabetes received either basal bolus treatment with Lantus once daily or NPH human insulin once or twice daily for 28 weeks. Regular human insulin was administered before each meal. Lantus was administered at bedtime, and NPH human insulin was administered either once at bedtime or twice, in the morning and at bedtime. In another study, 619 patients with type 1 diabetes were treated for 16 weeks with basal bolus insulin where insulin lispro was used before each meal. Lantus was administered at bedtime and NPH insulin was administered once or twice daily. In all three of these studies, Lantus and NPH human insulin had a similar effect on glycohemoglobin with a similar overall rate of hypoglycemia. These studies established the efficacy of Lantus in adults with type 1 diabetes.
A randomized controlled clinical study was performed to evaluate Lantus in 349 pediatric patients with type 1 diabetes (ages 6-15 years). Patients were treated for 28 weeks with a basal bolus insulin regimen where regular human insulin was used before each meal. Lantus was administered once daily at bedtime and NPH human insulin was administered once or twice daily. Similar effects on glycohemoglobin and the incidence of hypoglycemia were observed in both treatment groups, establishing the efficacy of Lantus in pediatric patients with type 1 diabetes.
Lantus was also evaluated in 570 adults with type 2 diabetes over a 52-week period as part of a regimen of combination therapy with insulin and oral antidiabetic agents. Lantus administered once daily at bedtime was as effective as NPH human insulin administered once daily at bedtime in reducing glycohemoglobin and fasting glucose. Another study of 518 type 2 diabetics who did not use oral antidiabetic agents showed that Lantus was as effective as either once-daily or twice-daily NPH human insulin in reducing glycohemoglobin and fasting glucose, with a similar incidence of hypoglycemia.
What the Patient Should Know
Human insulin therapy may be associated with hypoglycemia, worsening of diabetic retinopathy, lipodystrophy, skin reactions (such as injection-site reaction, pruritus, and rash), allergic reactions, sodium retention, and edema. Hypoglycemia is the most common adverse effect of insulins, including Lantus. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.
Any change in insulin should be made cautiously and only under medical supervision. In clinical studies of adult patients, there was a higher incidence of treatment-emergent injection-site pain (2.7% Lantus versus 0.7% NPH). Pain at the injection site was usually mild and did not result in discontinuation of therapy.
Lantus must not be diluted or mixed with any other insulin or solution, as it may result in a delayed onset of action.