NOVOLOG SUMMARY
NovoLog® (insulin aspart [rDNA origin] injection) is a human insulin analog that is a rapid-acting, parenteral blood glucose-lowering agent.
NovoLog is indicated for the treatment of adult patients with diabetes mellitus, for the control of hyperglycemia. Because NovoLog has a more rapid onset and a shorter duration of action than human regular insulin, NovoLog given by injection should normally be used in regimens with an intermediate or long-acting insulin. NovoLog may also be infused subcutaneously by external insulin pumps. (See WARNINGS, PRECAUTIONS [especially Usage in Pumps ], Information for Patients [especially For Patients Using Pumps ], Mixing of Insulins, DOSAGE AND ADMINISTRATION, RECOMMENDED STORAGE.)
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NEWS HIGHLIGHTS
Published Studies Related to Novolog (Insulin Aspart Injection)
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.
Insulin detemir reduces weight gain as a result of reduced food intake in patients with type 1 diabetes. [2011.07]
CONCLUSIONS: The reduced weight gain with insulin detemir compared with NPH insulin is attributed to reduced energy intake rather than increased energy expenditure. This may be mediated by a direct or indirect effect of insulin detemir on the hormones that control satiety.
Clinical Trials Related to Novolog (Insulin Aspart Injection)
Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes [Active, not recruiting]
This trial is conducted in Europe.
The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood
glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added
to current OAD treatment in type 2 diabetes and to verify the safety of use ( number and
severity of episodes of hypoglycaemia, body weight and side effects).
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 NovoLogŪ in the United States. The safety of insulin nasal
spray and how well it is tolerated as compared to NovoLog will also be evaluated.
Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes [Completed]
This trial is conducted in Europe.
The aim of this trial is to investigate the efficacy and safety of an intensified treatment
regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more
convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in
subjects with type 2 diabetes.
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70. [Completed]
The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin
analogues will improve post prandial glycaemic control in patients with type 1 diabetes.
OBJECTIVE:
The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of
Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 30, 50 and 70 for a period of 12 hours
following a standard test meal on four days respectively in subjects with type 1 diabetes.
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children [Recruiting]
To determine whether insulin glulisine decreases the breakfast post prandial glycemic
excursion in comparison to insulin aspart.
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 >>
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Page last updated: 2011-12-09
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