Novolog (Insulin Aspart Injection) - Summary

NOVOLOG SUMMARY

NovoLog (insulin aspart [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. NovoLog is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker's yeast). Insulin aspart has the empirical formula C₂₅₆H₃₈₁N₆₅0₇₉S₆ and a molecular weight of 5825.8.

Treatment of Diabetes Mellitus

NovoLog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

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NEWS HIGHLIGHTS

Published Studies Related to Novolog (Insulin Aspart Injection)

Comparative pharmacokinetics and insulin action for three rapid-acting insulin analogs injected subcutaneously with and without hyaluronidase. [2013]
CONCLUSIONS: Coinjection of rHuPH20 with rapid-acting analogs accelerated insulin

Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. [2011.09.01]
OBJECTIVE: To compare the efficacy and safety of 2 intensification strategies for stepwise addition of prandial insulin aspart in patients with type 2 diabetes mellitus treated with insulin detemir... CONCLUSION: The SimpleSTEP and ExtraSTEP strategies for stepwise addition of insulin aspart to 1 or more meals were equally effective at intensifying therapy in patients with type 2 diabetes not achieving glycemic control on basal insulin and oral antidiabetic drugs.

Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes. [2011.09]
As basal insulin analogues are being used off-label, there is a need to evaluate their safety (maternal hypoglycaemia and fetal and perinatal outcomes) and efficacy [haemoglobin A1c(HbA1c), fasting plasma glucose, and maternal weight gain]. The aim of this review is to provide an overview of the current literature concerning basal insulin analogue use in diabetic pregnancy, and to present the design and preliminary, non-validated baseline characteristics of a currently ongoing randomized, controlled, open-label, multicentre, multinational trial comparing insulin detemir with neutral protamine hagedorn insulin, both with insulin aspart, in women with type 1 diabetes planning a pregnancy (n = 306) or are already pregnant (n = 164).

Non-glycemic effects of insulin therapy: a comparison between insulin aspart and regular human insulin during two consecutive meals in patients with type 2 diabetes. [2011.08]
OBJECTIVE: To control postprandial hyperglycemia in insulin-treated type 2 diabetic patients, prandial therapy with regular human insulin (HI) or fast acting insulin analogs is used. Postprandial hyperglycemia seems to be reduced more effectively with insulin analogs than with normal insulin, but there are no data concerning the effect on lipolysis or pancreatic insulin and proinsulin secretion of normal insulin in comparison to insulin analogs... CONCLUSION: In the setting of two consecutive meals, IA reduces lipolysis and proinsulin secretion more effectively than HI.

Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. [2011.07]
BACKGROUND: The Initiation of Insulin to reach A1C Target (INITIATEplus) trial studied the effect of self-titrating biphasic insulin aspart 70/30 (BiAsp 30) twice daily during 24 weeks in insulin-naive patients with type 2 diabetes who were poorly controlled by oral medication, and originally randomized according to frequency of dietary counseling interventions. OBJECTIVE: The purpose of this study was to compare the efficacy and tolerability of biphasic insulin aspart 70/30 (BIAsp 30, NovoLog Mix 70/30) in INITIATEplus patients </=65 versus >65 years old, irrespective of dietary counseling frequency, and to test the hypothesis that self-titrating BIAsp 30 in patients >65 years old could be well-tolerated and effective in this age group... CONCLUSIONS: Self-titrated biphasic insulin aspart 70/30 was found to be well-tolerated and effective in type 2 diabetes patients >65 years old, as well as in patients </=65 years old. HbA(1c) and fasting plasma glucose decreases were significantly (P < 0.05) higher for patients >65 years old versus patients </=65 years old. Tolerability was indicated by major and minor hypoglycemia rates at or below <0.5 episodes ppy in both age groups. Overall rates of AE and serious AEs were higher among patients > 65 years; withdrawals related to AEs were 2% compared with 1.3% in the younger age group. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

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Clinical Trials Related to Novolog (Insulin Aspart Injection)

A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients [Completed]
Insulin is a hormone which is produced by the human pancreas for the lowering of blood sugar. In patients who don't produce enough insulin, additional insulin must be given several times per day by injections. Nastech Pharmaceutical Company Inc. has developed a new insulin nasal spray, as a possible way to improve patient compliance with intensive insulin treatment plans. This study is being conducted to see how Nastech's insulin nasal spray affects post-meal glucose levels compared with rapid acting insulin (i. e., insulin aspart) in Type 2 diabetics who are already taking oral antidiabetic medications and/or insulin therapy. Insulin aspart is marketed as NovoLog® in the United States. The safety of insulin nasal spray and how well it is tolerated as compared to NovoLog will also be evaluated.

Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids [Completed]
The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.

Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes [Completed]
Rationale: For the development of a closed loop system, faster insulin absorption after bolus administration could help to reduce the system's delay and thus increase patient safety. It has been shown that regular insulin absorption is faster when injecting insulin with a sprinkler needle (containing holes in the walls and being sealed at the tip). The current study will evaluate the impact of different application volumes on pharmacokinetic and pharmacodynamic properties of rapid acting insulin analogue (insulin aspart). Objective: To compare the pharmacokinetic response (based on the time to maximum observed serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with type 1 diabetes. Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study. Population: Twelve type 1 diabetic subjects Intervention: The investigational treatment is the subcutaneous administration of insulin aspart either as one bolus of 18 IU at one injection site or as 9 separately and simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an 8-hour clamp experiment. Patients will undergo both investigational treatments in a randomized order; between the two clamp visits there will be a wash-out period of 5-21 days. Main study endpoint: Time to maximum observed serum insulin aspart concentration.

Bioequivalence of Two NovoLog� Formulations in Subjects With Type 1 Diabetes [Completed]
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.

The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children [Completed]
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.

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Reports of Suspected Novolog (Insulin Aspart Injection) Side Effects

Blood Glucose Increased (91),  Blood Glucose Decreased (43),  Diabetic Ketoacidosis (23),  Hypoglycaemia (21),  Hypoglycaemic Unconsciousness (21),  Nausea (17),  Drug Ineffective (16),  Dyspnoea (16),  Vomiting (16),  Dehydration (16), more >>