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In July 1999, John Buse, MD, PhD, CDE, director of the University of North Carolina's Diabetes Center told Diabetes Health that patients enrolled in clinical trials for insulin glargine (Lantus) absolutely "loved" the 24-hour-a-day long-acting (basal) insulin. Most of the people who participated in the clinical trials were not doing well on just NPH or Ultralente, and Lantus improved their control. However, Buse added, "[The clinical-trial participants are] upset that they cannot continue on it." That was because, at the time, the clinical trials had ended and the participants were told they would have to wait at least one year for FDA approval of Lantus and longer until they could get their hands on it.
On April 24, 2000, the FDA granted approval to Lantus. Thirteen months later, on May 22, 2001, it finally arrived on pharmacy shelves.
The First 24-Hour-a-Day Insulin
"Lantus is an exciting new treatment option," says Matthew C. Riddle, MD, head, section of diabetes and professor of medicine at Oregon Health Sciences University. "Lantus may change the way diabetes is treated because it may allow people with diabetes who have needed multiple daily injections of long-acting insulin to only take one injection a day to manage their basal insulin needs."
Steven Edelman, MD, of Veteran's Hospital in San Diego, is also very excited for his patients that Lantus is finally available.
"Lantus is an advancement in basal insulin coverage," he says.
Manufactured by Aventis Pharmaceuticals of Bridgewater, New Jersey, Lantus will be available by prescription only. The insulin will be Aventis's first available on the U.S. market and makes the company the third player in the insulin market (Eli Lilly and Novo Nordisk are the others.) Lantus has no pronounced peak and is indicated for once-daily administration at bedtime in the treatment of adult and pediatric patients—ages six and older—with type 1 diabetes or adult patients with type 2 diabetes who require basal insulin for the control of high blood sugars.
Lantus is the first and only insulin analog that provides 24-hour glucose lowering activity with just one shot. However, be advised that this does not mean this is a "one-shot-of-insulin-per-day" insulin. Lantus is not meant to replace short-acting insulins, such as Regular or Humalog, which provide a "bolus" at meal-time.
"Going on Lantus requires one injection at bedtime of Lantus plus Lispro or Regular with each meal," says Robert Tanenberg, MD, FACP, professor of medicine, section of Endocrinology at Brody School of Medicine at East Carolina University in Greenville, North Carolina.
Since the FDA and Aventis advise users not to mix Lantus with any other insulin in the same syringe, any patient who uses it will need to take four shots per day if they eat three meals (i.e., Lantus at bedtime, plus a shot before each meal).
Studies and Usage
The safety and effectiveness of Lantus given once daily at bedtime was studied in more than 4,000 patients in six open-label, randomized, parallel studies and was compared to the safety and efficacy of NPH human insulin (see chart on page 41).
Results from another study, published in the April issue of Diabetes Care, show that Lantus is less likely to cause low blood sugars at night and a gain in weight in people with type 2 diabetes. For the study, Julio Rosenstock, MD, and colleagues at the Dallas Diabetes and Endocrine Center, studied the effects of Lantus and NPH insulin on 518 people with type 2 diabetes. In total, 259 patients were randomly assigned Lantus while the remaining 259 were given NPH insulin either at bedtime or in the morning and at bedtime.
Both of the groups showed improvements in their HbA1c and fasting BG levels. The Lantus group achieved a 25-percent drop in severe nighttime hypoglycemia (one Lantus patient versus six NPH patients experienced lows).
The patients treated with Lantus also gained less weight—an average of .9 pounds versus 3.1 pounds in the NPH group.
Researchers conclude that, "The lower risk of [nighttime] hypoglycemia reflects the smooth, peakless activity profile of [Lantus] compared with the peak of NPH, which can result in maximum concentrations of insulin at night when NPH is given at bedtime."
"It is an important addition to both intensive-insulin therapy regimens and to combination therapy with oral agents in type 2 diabetes," says Daniel Einhorn, MD, FACE, medical director of Scripps/Whittier Diabetes Institute in La Jolla, California.
Who Will Benefit From Lantus?
Edelman says the benefits of taking Lantus for a patient who was only taking two shots of Lente per day is "less peaks and valleys" and "consistent absorption on a day-to-day basis."
Aventis says people with diabetes should consider talking with their doctor or healthcare provider about Lantus if the following conditions apply:
Who Won't Benefit?
Einhorn says patients with highly variable basal needs, "which we do see in some pump patients," should not consider taking Lantus.
Tanenberg advises that those with type 2 in good control without hypoglycemia should not consider Lantus.
In addition, "any type 1 who refuses to take four insulin injections per day and do fingerstick BG tests at these times should not change to Lantus," he says.
Words of Advice if You're Thinking of Trying Lantus
If you are thinking of switching to Lantus, Einhorn says it is important to proceed with caution. The conversion with NPH, Lente or UltraLente is unit for unit, meaning that if you were taking two 12-unit shots of Lente, upon converting to Lantus you would need to take one 24-unit shot.
"But I reduce by 25 percent for the first few days then titrate up as indicated by monitoring," says Einhorn.
Aventis advises that Lantus "must not be diluted or mixed with any other insulin or solution."
"If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner."
In clinical studies, there was a higher incidence of injection site pain (2.7 percent with Lantus versus 0.7 percent with NPH users). The reports of pain at the injection site were usually mild and did not result in discontinuation of therapy.
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 and glucose monitoring is recommended for all patients with diabetes.
Don't Forget What We Have Learned
Lantus doesn't change the need for multiple testing and injecting.
"You still need to bolus with meals and monitor events," says Einhorn. "The difference is having a consistent predictable baseline and not having any period in the 24 hours where you run out of insulin action."
Lisa Kennedy, an Aventis spokeswoman, told Diabetes Health that Lantus is distributed through all the major wholesalers. Therefore, all major chains and independent pharmacists can readily access it.
Kennedy says Lantus is "competitively priced" compared to other new insulin treatments. The manufacturer's suggested price is $43.51 per 10-ml vial.
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.