Apidra (Insulin Glulisine) - Summary

APIDRA SUMMARY

APIDRA™ (insulin glulisine [rDNA origin]) is a human insulin analog that is a rapid-acting, parenteral blood glucose lowering agent. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid.

APIDRA is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.

APIDRA has a more rapid onset of action and a shorter duration of action than regular human insulin. APIDRA should normally be used in regimens that include a longer-acting insulin or basal insulin analog. (See WARNINGS and DOSAGE AND ADMINISTRATION.)

APIDRA may also be infused subcutaneously by external insulin infusion pumps. (See WARNINGS, PRECAUTIONS, Usage in Pumps, Information for Patients, Mixing of Insulins, DOSAGE AND ADMINISTRATION, RECOMMENDED STORAGE.)

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NEWS HIGHLIGHTS

Published Studies Related to Apidra (Insulin Glulisine)

Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. [2009.09]
AIM: To evaluate the safety and efficacy of insulin glulisine (glulisine) with and without oral antidiabetic drugs (OAD; sulphonylurea or sulphonylurea + biguanide) relative to that of OAD alone in Japanese and Korean patients with inadequately controlled type 2 diabetes mellitus (T2DM)... CONCLUSIONS: Both glulisine + OAD and glulisine monotherapy were well tolerated and effective for Japanese and Korean patients with T2DM mellitus inadequately controlled by OAD therapy alone.

Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. [2009.07]
CONCLUSIONS: Regular and glulisine insulin are equally effective during the acute treatment of DKA. A transition to subcutaneous glargine and glulisine after resolution of DKA resulted in similar glycemic control but in a lower rate of hypoglycemia than with NPH and regular insulin. Thus, a basal bolus regimen with glargine and glulisine is safer and should be preferred over NPH and regular insulin after the resolution of DKA.

Effect of insulin glulisine on microvascular blood flow and endothelial function in the postprandial state. [2008.05]
CONCLUSIONS: Insulin glulisine is superior to human insulin in restoring postprandial metabolic and microvascular physiology.

A comparison of preprandial insulin glulisine versus insulin lispro in people with Type 2 diabetes over a 12-h period. [2008.02]
A comparison of the plasma glucose and insulin day profiles between two prandial rapid-acting insulin analogues, insulin glulisine (glulisine) and insulin lispro (lispro), in 18 obese subjects with Type 2 diabetes. Subjects (body mass index: males, 36.7 [33.2-43.8] kg/m(2); females, 40.0 [35.7-46.5] kg/m(2)) received subcutaneous glulisine or lispro (0.15 U/kg) at 4-h intervals immediately (within 2 min) before three standard test meals during each of two 12-h, randomised, open-label, crossover studies (7+/-2-day interval between each)...

Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). [2007.09]
CONCLUSIONS: Treatment with insulin glargine and glulisine resulted in significant improvement in glycemic control compared with that achieved with the use of SSI alone. Our study indicates that a basal-bolus insulin regimen is preferred over SSI in the management of non-critically ill, hospitalized patients with type 2 diabetes.

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Clinical Trials Related to Apidra (Insulin Glulisine)

Insulin Glulisine Administered Pre-Meal Versus Post-Meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin [Completed]
The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.

Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes [Completed]
The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin.

The secondary objectives are to evaluate the postprandial time course of the following efficacy parameters after injection of insulin glulisine compared with regular insulin on

- Blood Glucose

- Insulin

- Intact proinsulin

- Asymmetric dimethylarginine (ADMA)

- Metal matrix proteasis (MMP-9)

- Oxidative status (per ox)

- Interleukin 18 (IL-18)

- Free fatty acids (FFA)

- Oxidised LDL (ox-LDL)

- Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)

- Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)

Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2) [Completed]
The purpose of this study is to test for superiority in improvements from baseline in patient reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin glargine plus rapid acting insulin glulisine MDI versus treatment with premix insulin.

Insulin Glargine "All to Target" Trial [Recruiting]
All To Target Trial Lantus® (insulin glargine) with stepwise addition of APIDRA®(insulin glulisine) or Lantus with one injection of Apidra vs. a twice-daily premixed insulin regimen (Novolog® Mix 70/30) in adult subjects with type 2 diabetes failing dual or triple therapy with oral agents: a 64-week, multi-center, randomized,parallel, open- label clinical study.

Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus [Completed]
The purpose of this study is to show the non-inferiority of insulin glulisine administered with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c (HbA1c), from baseline to study week 24.

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