General Information

Lantus is a sterile solution of insulin glargine for use as an injection. The primary activity of insulin 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.

Lantus is specifically indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

Lantus is supplied as 10 mL vials, 3 mL cartridges or as a 3 mL SoloStar disposable insulin device, all designed for subcutaneous administration. Lantus should be administered subcutaneously once a day at the same time every day. The desired blood glucose levels as well as the doses and timing of antidiabetes medications must be determined individually.

Clinical Results

FDA Approval
The FDA approval of Lantus was based on the following trials:

Type 1 Diabetes-Adults
Study A
This randomized, controlled study enrolled 585 subjects who were randomized to basal-bolus treatment with Lantus (once daily at bedtime) or to NPH human insulin (once daily in the morning or at bedtime or twice daily at bedtime) and treated for 28 weeks. Regular human insulin was administered before each meal. The results were as follows:
HbA1c adjusted mean change from baseline: Lantus +0.21 and NPH +0.10.
the basal insulin dose mean change from baseline: Lantus -1.7 and NPH -0.3
the total insulin dose mean change from baseline: Lantus -1.1 NPH -0.1
the adjusted mean change from baseline in fasting blood glucose (mg/dL): Lantus -21.1 and NPH -16.0.
Study B
This randomized, controlled study enrolled 534 subjects who were randomized to basal-bolus treatment with Lantus (once daily at bedtime) or to NPH human insulin (once daily in the morning or at bedtime or twice daily at bedtime) and treated for 28 weeks. Regular human insulin was administered before each meal. The results were as follows:
HbA1c adjusted mean change from baseline: Lantus -0.16 and NPH -0.21.
the basal insulin dose mean change from baseline: Lantus -4.1 and NPH +1.8
the total insulin dose mean change from baseline: Lantus +0.3 NPH +3.7
the adjusted mean change from baseline in fasting blood glucose (mg/dL): Lantus -20.2 and NPH -16.9.
Study C
This randomized, controlled clinical study enrolled 619 subjects with type 1 diabetes who were treated for 16 weeks with a basal-bolus insulin regimen where insulin lispro was used before each meal. Lantus was administered once daily at bedtime and NPH human insulin was administered once or twice daily. The results were as follows:
HbA1c adjusted mean change from baseline: Lantus -0.07 and NPH -0.08
the basal insulin dose mean change from baseline: Lantus -4.5 and NPH +0.9
the total insulin dose mean change from baseline: Lantus -2.9 NPH +0.3
the adjusted mean change from baseline in fasting blood glucose (mg/dL): Lantus -29.3 and NPH -11.9

Type 1 Diabetes–Pediatric
Study D
This randomized, controlled clinical study enrolled 349 pediatric patients (age range 6 to 15 years) with type 1 diabetes> The subjects 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. The results were as follows:
HbA1c adjusted mean change from baseline: Lantus +0.28 and NPH +0.27
the basal insulin dose mean change from baseline: Lantus -1.3 and NPH +2.4
the total insulin dose mean change from baseline: Lantus +1.9 NPH +3.4
the adjusted mean change from baseline in fasting blood glucose (mg/dL): Lantus -23.2 and NPH -12.2.

Type 2 Diabetes–Adult
Study E
This randomized, controlled clinical study enrolled 570 siubjects. Lantus was evaluated for 52 weeks as part of a regimen of combination therapy with insulin and oral antidiabetes agents (a sulfonylurea, metformin, acarbose, or combinations of these drugs). Lantus administered once daily at bedtime was as effective as NPH human insulin administered once daily at bedtime in reducing glycohemoglobin and fasting glucose. The results were as follows:
HbA1c adjusted mean change from baseline: Lantus -0.46 and NPH -0.38
the basal insulin dose mean change from baseline: Lantus +11.5 and NPH +9.0
the total insulin dose mean change from baseline: Lantus +11.5 NPH +9.0
the adjusted mean change from baseline in fasting blood glucose (mg/dL): Lantus -49.0 and NPH -46.3.
Study F
This randomized, controlled clinical study enrolled 518 patients with type 2 diabetes not using oral antidiabetes agents. The subjects received a basal-bolus regimen of Lantus once daily at bedtime or NPH human insulin administered once or twice daily for 28 weeks. Regular human insulin was used before meals as needed. Lantus had similar effectiveness as either once- or twice-daily NPH human insulin in reducing glycohemoglobin and fasting glucose with a similar incidence of hypoglycemia. The results were as follows:
HbA1c adjusted mean change from baseline: Lantus -0.41 and NPH -0.59
the basal insulin dose mean change from baseline: Lantus -1.2 and NPH +7.0
the total insulin dose mean change from baseline: Lantus +10.0 NPH +11.1
the adjusted mean change from baseline in fasting blood glucose (mg/dL): Lantus -23.8 and NPH -21.6

Lantus Flexible Daily Dosing
Study G
This randomized, controlled clinical study enrolled 378 subjects with type 1 diabetes. Lantus was administered pre-breakfast, pre-dinner, or at bedtime. Subjects were also treated with insulin lispro at mealtime. Lantus administered at different times of the day resulted in similar reductions in glycated hemoglobin compared to that with bedtime administration.
Study H
This randomized, active-controlled study enrolled 697 subjects with type 2 diabetes no longer adequately controlled on oral agent therapy. Lantus was administered pre-breakfast or at bedtime; a subjects also received AMARYL (glimeperide) 3 mg daily. Lantus given before breakfast was at least as effective in lowering glycated hemoglobin A1c (HbA1c) as Lantus given at bedtime or NPH human insulin given at bedtime.