In the INSIGHT study
Adding Lantus® to OADs Helped Many Patients Reach A1C Goal
- Patients treated with Lantus® were significantly more likely (1.68 times) to
achieve 2 consecutive A1C values ≤6.5% vs patients treated with adjustments of
OADs alone (P=0.049), and achieved it significantly earlier (P=0.041)
Study Design
In a 24-week study, patients with type 2 diabetes were randomized to starting Lantus®
plus self-titration (n=206) or conventional therapy with physician adjustment of
oral glucose-lowering agents (n=199). Patients had to be taking 0, 1, or 2 OADs,
with at least 1 of the OADs taken at half or below half-maximal dose at study start.
Patients could not have any substantial change in oral dose for at least 3 months
before randomization. Primary endpoint was first achievement of 2 consecutive A1C
levels ≤6.5%.
- At any point during the study, 58.3% of patients treated with Lantus® + OADs
achieved an A1C ≤7% compared with 44.2% of those on OADs alone (P=0.005)
- Mean A1C at endpoint was 6.96% for Lantus® + OADs, and 7.24% for adjustment
of OADs alone after adjustment for baseline levels, site, and stratum; P=0.0007
difference between groups
Fixing fastings first with once-daily Lantus® helped many patients achieve glycemic
goals
Safety Results
Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)
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.
Important Safety Information for Lantus®
SoloSTAR®
Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure
an accurate dose each time, patients should follow all steps in the Instruction
Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin,
which may affect their blood glucose.
Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)
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 for Lantus®.
References:
- Gerstein HC, Yale J-F, Harris SB, et al. Diabetic Med. 2006;23(7):736-742.
- Data on file, Sanofi U.S. LLC.
Indications and Usage for Lantus® (insulin glargine
[rDNA origin] injection)
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.
Important Safety Information for Lantus® (insulin
glargine [rDNA origin] injection)
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.
Important Safety Information for Lantus® SoloSTAR®
Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure
an accurate dose each time, patients should follow all steps in the Instruction
Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin,
which may affect their blood glucose.
Click here for additional Important Safety Information.