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)
Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. [2009.10.12]
Abstract Objectives: To assess the efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) and insulin glargine, administered once daily in subjects with type 2 diabetes inadequately controlled with oral anti-diabetic drugs. Research design and methods: In this 26-week, open-labeled, randomized, parallel-group, multinational, treat-to-target trial, 480 insulin-naive subjects were randomized to receive either BIAsp 30 before dinner or insulin glargine at bedtime, both in combination with metformin and glimepiride.
Risk for nocturnal hypoglycemia with biphasic insulin aspart 30 compared with biphasic human insulin 30 in adults with type 2 diabetes mellitus: a meta-analysis. [2009.08]
BACKGROUND: Insulin is recommended as a second-line treatment after diet and metformin fail to reach and/or maintain glycemic targets considered to minimize the risk for long-term diabetic complications. Hypoglycemia and the fear of developing hypoglyce-mia, however, remain substantial barriers to the initiation and optimal use of insulin. OBJECTIVE: The aim of this study was to compare biphasic insulin aspart 30 (BIAsp 30) with biphasic human insulin 30 (BHI 30) with respect to glycemic control and the risk for hypoglycemia using a meta-analysis of clinical trials comparing these insulins in patients with type 2 diabetes mellitus (T2DM)... CONCLUSION: This meta-analysis found BIAsp 30 to be associated with a significantly lower rate of nocturnal and major hypoglycemia, but a significantly increased risk for daytime hypoglycemia, compared with BHI 30 at a similar level of HbA(1c) in patients with T2DM.
Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. [2009.07]
AIM: To evaluate clinical efficacy and safety of biphasic insulin aspart (BIAsp) 30 twice daily (b.i.d.) vs. BIAsp 50 or BIAsp 70 (high-mix regimens) thrice daily (t.i.d.) all in combination with metformin in a 36-week clinical trial in subjects with type 2 diabetes... CONCLUSIONS: Glycaemic control improved with BIAsp 50 t.i.d. without higher incidence of hypoglycaemia compared with BIAsp 30 b.i.d.; with BIAsp 70 t.i.d. lower PG levels from lunch to 02.00 hours, but more hypoglycaemic episodes were obtained compared with BIAsp 30 b.i.d.
Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial. [2009.04]
BACKGROUND: Patients with type 2 diabetes (T2DM) have an increased mortality rate primarily because of macrovascular disease. Where T2DM patients cannot be managed sufficiently through diet, exercise and peroral antidiabetic drugs, that is when haemoglobin A1c (HbA1c) is above 7.0%, it is yet unknown whether a combination of metformin and insulin analogues is superior to insulin analogues alone. Nor is it known which insulin analogue regimen is the optimal. OBJECTIVE: The primary objective of this trial is to evaluate the effect of an 18-month treatment with metformin vs. placebo in combination with one of three insulin analogue regimens, the primary outcome measure being carotid intima-media thickness (CIMT) in T2DM patients... CONCLUSION: CIMT is designed to provide evidence as to whether metformin is advantageous even during insulin treatment and to provide evidence regarding which insulin analogue regimen is most advantageous with regard to cardiovascular disease.
Safety and efficacy of inhaled insulin (AERx iDMS) compared with subcutaneous insulin therapy in patients with Type 1 diabetes: 1-year data from a randomized, parallel group trial. [2009.03]
AIMS: Assessment of the long-term safety and efficacy of liquid inhaled insulin via AERx insulin Diabetes Management System (iDMS) in a basal/bolus treatment regimen of adults with Type 1 diabetes... CONCLUSIONS: The safety and efficacy results in this trial were similar to those reported with other inhaled insulins; however, inhaled insulin using AERx iDMS requires further optimization to reduce nocturnal hypoglycaemia before it has comparable safety and efficacy to s.c. insulin aspart.
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 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.
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.
Comparison of Insulins Aspart and Lispro in Insulin Pumps [Active, not recruiting]
The purpose of the study is to study compare the glycemic control between insulins aspart and
lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes
using an insulin pump.
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