Lantus (insulin glargine [rDNA origin] injection)
Company: Aventis Pharmaceuticals
Approval Status: Approved April 2000
Treatment for: For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia
Areas: Endocrinology; Pediatrics/Neonatology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
Lantus is the first FDA approved long-acting (basal) recombinant human insulin analog with a once-daily administration and a 24-hour glucose-lowering effect. This biosynthetic insulin, injected subcutaneously and designed to mimic NPH human insulin, is indicated for both adult and pediatric patients with Type 1 diabetes. It may also be used for the treatment of adults with Type 2 diabetes who require basal insulin for the control of hyperglycemia.
The chemical structure of Lantus allows for regulated release of the insulin into the circulation with a glucose-lowering effect over a 24-hour period. In clinical studies, no specific pronounced peak was detected over this period.
Clinical Results
In clinical studies, the efficacy of Lantus, measured by metabolic control, was comparable to NPH human insulin. In addition, Lantus had a slower absorption rate than NPH human insulin. This absorption allowed for a relatively constant concentration/time profile over 24-hours. The glucose-lowering effect was detected over the entire 24-hour period.
Side Effects
As with other insulin therapies, Lantus can cause the following side effects (with hypoglycemia being the most common adverse effect):
- Hypoglycemia
- Worsening of diabetic retinopathy
- Lipodystrophy
- Skin reactions (such as injection-site reaction, pruritus, and rash)*
- Allergic reactions
- Sodium retention
- Edema
*In clinical trials, patients treated with Lantus had a higher incidence of injection-site pain (2.7%) than did patients receiving NPH human insulin (0.7%). In general, the reports of pain were mild and did not require discontinuation of treatment with the insulin therapy.
All patients with diabetes should have regular glucose monitoring.
Mechanism of Action
The primary activity of insulin, including insulin glargine, is
regulation of glucose metabolism. 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.
(From FDA Label)
Additional Information
Visit the Aventis Pharmaceuticals, Inc. web site to learn more about Lantus and about other products, research, and services provided by the company that developed this drug.
To learn more about diabetes in adults and children, and treatments for this disease, visit the web sites of the American Diabetes Association and the Juvenile Diabetes Foundation International.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
