Lantus (insulin glargine [rDNA origin] injection)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia
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