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Real-World Results

Real Results in Patients Who Added LANTUS® to their Existing Oral Regimens

The Schreiber Study is a large real-world study of diabetes patients who added LANTUS®, a long-acting (basal) insulin, to their existing oral regimens. The results are presented below. In a large-scale observational study1,2:

OADs Taken at Baseline

Mean baseline characteristics of 12,216 patients

  • A1C: 8.7% (±1.4%)
  • BMI: 29.0 (±4.7%) kg/m2 11
  • Age: 63.9 (±11.3) years

TZD=Thiazolidinedione

aPercentages total >100% because of combination therapy.

LANTUS® + OADs Improved Sustained Glycemic Control for up to 32 Months 1, 2

Link to reference Link to reference Link to reference Link to reference Mean A1C Levels

Sustained glycemic control: fasting blood glucose (FBG) reductions at 32 months1

  • Average 71.8-mg/dL drop in FBG through 32 months (n=1710)b
  • Mean reduction in A1C through 32 months was 1.6% from a mean baseline of 8.6% (n=1602)b

Neutral effect on weight and BMI at 32 months1

  • Mean patient weight (n=1369)b: baseline=83.0 (±14.8) kg; 32 months=82.2 (±14.6) kg
  • Mean patient BMI (n=1351)b: baseline=28.9 (±4.6) kg/m2; 32 months=28.6 (±4.7) kg/m2

b=number of patients with data available at baseline and 32 months.

Safety at 9 and 32 months1,2

  • Because of the observational nature of this study with no stringent emphasis on reporting or documenting these events, these results must be interpreted with caution as it is possible that adverse events (AEs) may have been underreported
  • Hypoglycemia occurred in 0.1% of patients at 9 months
  • During the 32-month observation period, there was a total of 2 hypoglycemic events; 1915 patients were enrolled in the 32-month follow-up
  • Patients with any AEs: 9 months=142 (1.2%); 32-month observation period=54
  • Patients with adverse drug reactions: 9 months=26 (0.2%); 32-month observation period=4

Administration options >

Important Safety Information for Lantus®

CONTRAINDICATIONS

Lantus® is contraindicated in patients hypersensitive to insulin glargine or one of its excipients.

WARNINGS AND PRECAUTIONS

Monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment.

Do not dilute or mix Lantus® 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. Do not administer Lantus® via an insulin pump or intravenously because severe hypoglycemia can occur. Insulin devices and needles must not be shared between patients.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®, and may be life-threatening.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur.

A reduction in the Lantus® dose may be required in patients with renal or hepatic impairment.

DRUG INTERACTIONS

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).

ADVERSE REACTIONS

Other adverse reactions commonly associated with Lantus® are injection site reaction, lipodystrophy, pruritus, and rash.

Indications and Usage for Lantus®

Lantus® is a long-acting insulin analog indicated to improve glycemic control in adults and children (6 years and older) with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Lantus® should be administered once a day at the same time every day.

Important Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

Lantus® SoloSTAR® is a disposable prefilled insulin pen.

Please click here for full prescribing information.


Important Safety Information for Apidra®
(insulin glulisine [rDNA origin] injection)

CONTRAINDICATIONS

Apidra® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Apidra® or any of its excipients.

WARNINGS AND PRECAUTIONS

Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. As with all insulin preparations, the time course of Apidra® action may vary by individual or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Apidra®, which may be serious.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. All insulins, including Apidra®, can cause hypokalemia, which if untreated, may be serious.

A reduction in the Apidra® dose may be required in patients with renal or hepatic impairment.

Apidra® for subcutaneous injection should not be mixed with insulins other than NPH. Do not mix Apidra® with any insulin when used in the pump or for intravenous administration. Insulin devices and needles must not be shared between patients.

DRUG INTERACTIONS

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).

ADVERSE REACTIONS

Other adverse reactions commonly associated with Apidra® include injection site reactions, lipodystrophy, pruritus, and rash.

Indications and Usage for Apidra®

Apidra® is a rapid-acting insulin analog indicated to improve glycemic control in adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes.

When used as a mealtime insulin, the dose of Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal. Apidra® should normally be used in regimens that include a longer-acting insulin.

Please click here for full prescribing information for Apidra®


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