The FDA has approved Basaglar, a long-acting human insulin analog, to improve glycemic control in adults and children with type 1 diabetes and in adults with type 2 diabetes.
The FDA has approved Basaglar (insulin glargine injection; Eli Lilly and Company), a long-acting human insulin analog, to improve glycemic control in adults and children with type 1 diabetes and in adults with type 2 diabetes. The approval carries the limitation that Basaglar should not be used for the treatment of diabetic ketoacidosis.1 Basaglar has an identical amino acid sequence as Lantus, another U-100 insulin glargine,2 and was approved through an abreviated approval process that partly relied on the FDA’s previous finding of safety and effectiveness for Lantus. Basaglar was found sufficiently similar to Lantus, and data were provided specific to Basaglar to establish its safety and efficacy for its approved uses.3
PHARMACOLOGY AND PHARMACOKINETICS
Insulin’s primary activity is the regulation of glucose metabolism. Insulin and insulin analogs stimulate peripheral glucose uptake, especially by skeletal muscle and fat, and inhibit hepatic glucose production to lower blood glucose.
A single subcutaneous 0.5-U/kg dose of Basaglar demonstrated a serum concentration with a slow and prolonged absorption and a relatively constant concentration/ time profile over 24 hours, with no pronounced peak. The average time to maximum serum insulin concentration was 12 hours after injection. Serum insulin concentrations declined to baseline by approximately 24 hours.1
DOSAGE AND ADMINISTRATION
The dose of Basaglar should be individualized based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. It should be given subcutaneously once daily, at the same time each day. The injection sites should be rotated to reduce the risk of lipodystrophy. When treatment with Basaglar begins, blood glucose levels should be monitored closely for the initial weeks. Basaglar should not be diluted or mixed with any other insulin or solution.1
The safety and effectiveness of Basaglar in patients with type 1 diabetes was evaluated in a 52-week, phase 3, randomized, open-label study of 535 adult patients. Study participants received either Basaglar plus insulin lispro or another insulin glargine 100-U/mL product (either US-approved Lantus or non—US-approved Lantus) plus insulin lispro. Basaglar was found to be noninferior, as determined by change in glycated hemoglobin (A1C) levels at 24 weeks, with a mean A1C level reduction of 0.35% in the Basaglar group compared with 0.46% in the Lantus group. In addition, the percentage of patients who achieved A1C levels <7% in the Basaglar group (34.5%) was comparable to the Lantus group (32.2%).
The safety and effectiveness of Basaglar in patients with type 2 diabetes was evaluated in a 24-week, phase 3, randomized, double-blind study of 756 adult patients who were either insulin-naïve and failed to achieve adequate glycemic control on at least 2 oral antidiabetic medications or who were already on another insulin glargine 100-U/mL product (either US-approved Lantus or non—US-approved Lantus), along with 2 or more oral antidiabetic medications with adequate or inadequate glycemic control. Noninferiority was demonstrated by changes in A1C levels: the Basaglar group had a reduction of 1.29% and the Lantus group had a reduction of 1.34%. In addition, a comparable percentage of patients achieved A1C levels <7% in the Basaglar group (49%) and in the Lantus group (53%).1,4
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
Basaglar is contraindicated in patients experiencing an episode of hypoglycemia or in patients with hypersensitivity to Basaglar or any of its components. The Basaglar KwikPen device should never be shared between patients, even if the needle is changed. Changes to any insulin regimen may lead to hyperglycemia or hypoglycemia; blood glucose should be monitored closely during insulin adjustments. Potentially life-threatening hypoglycemia may occur with changes to insulin dosage, meal patterns, or physical activity; co-administration of glucose-lowering medications; or in patients with renal or hepatic impairment and hypoglycemic unawareness.
Patients should always check their insulin labels prior to injection. Generalized allergy reactions, including anaphylaxis, can occur and may be severe and life-threatening. Hypokalemia may occur and may be life-threatening, as well; potassium levels should be monitored in patients at risk of hypokalemia and treated, if appropriate. Patients concomitantly using thiazolidinediones should be observed for signs and symptoms of heart failure.
Concurrent administration of Basaglar with medications that affect glucose metabolism may require an adjustment to the Basaglar dose, with close monitoring of blood glucose. Antiadrenergic medications, such as beta-blockers, clonidine, guanethidine, and reserpine, may reduce or mask the signs of hypoglycemia.
The most common adverse reactions (≥5% incidence) are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.
- Basaglar [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015. uspl.lilly.com/basaglar/basaglar.html#pi. Accessed May 26, 2016.
- FDA approves Basaglar (insulin glargine injection), a long-acting insulin treatment [news release]. Indianapolis, IN, and Ridgefield, CT: Eli Lilly and Company; December 16, 2015. https://investor.lilly.com/releasedetail.cfm?ReleaseID=947336. Accessed May 26, 2016.
- FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes [news release]. Silver Spring, MD: FDA; December 16, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htm. Accessed May 26, 2016.
- Basaglar healthcare provider information. Basaglar website. basaglar.com/#. Accessed May 26, 2016.