Basal-Plus 1 Regimen
Proven A1C reduction with a Basal-Plus 1 regimen1 eases patients into mealtime therapy
Prandial insulin can be added in a stepwise fashion, starting with 1 dose at the largest meal2
Adapted from Raccah 2008.3
In the OPAL study, the Apidra® Basal-Plus 1 regimen helped patients reach A1C goal1
- Treatment equivalence of the 2 mealtime Apidra® regimens was demonstrated
- Adding 1 dose of Apidra® a day achieved significant A1C reductions from baseline to endpoint-breakfast group, from 7.35% to 7.03%; main meal group, from 7.29% to 6.94% (P<0.0001)
OPAL=Orals Plus Apidra® and
Main meal=meal producing the highest elevation of BG.
Results from a 26-week, multicenter, randomized, open-label, parallel-group study
of 316 patients with type 2 diabetes who were suboptimally controlled with
Rates of AEs in the OPAL study
Indications and Usage for
Lantus® (insulin glargine [rDNA origin] injection)
Important Limitations of Use:
Indications and Usage for Apidra® (insulin glulisine [rDNA origin] injection)
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® given by subcutaneous injection should normally be used in regimens that include a longer-acting insulin.
Important Safety Information for
Lantus® (insulin glargine [rDNA origin] injection) & Apidra® (insulin glulisine [rDNA origin] injection)
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. Modify 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 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
Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue
A reduction in the
Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.
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 commonly associated with
Important Safety Information for
- Lankisch MR, Ferlinz KC, Leahy JL, Scherbaum WA; Orals Plus Apidra and Lantus (OPAL) study group. Diabetes Obes Metab. 2008;10(12): 1178-1185.
- Nathan DM, Buse JB, Davidson MB, et al. Diabetes Care. 2009;32(1): 193-203.
- Raccah D, Bretzel RG, Owens D, Riddle M. Diabetes Metab Res Rev. 2007;23(4): 257-264.
- Data on file, Sanofi U.S. LLC.