NEWS HIGHLIGHTS
Published Studies Related to Novolog Mix 70 / 30 (Insulin Aspart Protamine Suspension / Insulin Aspart Injection)
Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. [2009.01]
CONCLUSIONS: Significantly more T2DM patients (poorly controlled with combination metformin/sulfonylurea) achieved glycemic goals when treated with BIAsp 30 than with exenatide. The high baseline HbA1c values (approximately 10.2%) and the long duration of diabetes (approximately 9 years) suggests that some subjects may have been in an advanced stage of their diabetes and may not have had sufficient beta-cell function for a GLP-1 mimetic to be effective. The insulin-treated groups had more minor hypoglycemic events and weight gain but less gastrointestinal side-effects. In summary, BIAsp 30 was more efficacious in helping patients with high baseline HbA1c achieve glycemic goals. Clinical trial registration: www.clinicaltrials.gov, NCT00097877.
Postprandial versus preprandial dosing of biphasic insulin aspart in elderly type 2 diabetes patients. [2004.10]
Preprandial dosing (within 5 min before meal) and postprandial dosing (15-20 min after meal onset) of NovoLog Mix 70/30 (BIAsp 30, a biphasic formulation of insulin aspart, 30% soluble and 70% protamine-crystallized) were compared in elderly (> or =65 years) type 2 diabetes patients in this open-label, 12-week, crossover study...
A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes. [2004.05]
CONCLUSIONS: Statistically, insulin aspart was not equivalent to another treatment in terms of HbA1c reduction. Insulin aspart treatment resulted in improved HbA1c and postprandial blood glucose. The application of insulin aspart was safe and well tolerated.
Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. [2004.04]
OBJECTIVE: The goal of this study was to compare the efficacy and safety profiles of biphasic insulin aspart 30 (30% soluble insulin aspart and 70% protaminated insulin aspart [BIAsp 30]) and biphasic insulin lispro 25 (25% soluble insulin lispro and 75% neutral protamine lispro [Mix25]) used in a BID injection regimen in patients with type 2 diabetes mellitus (DM). Also assessed was patients' preference for pen device--the NovoMix 30 FlexPen /NovoLog Mix 70/30 FlexPen (FlexPen) versus the Humalog Mix25 Pen/Humalog Mix75/25 Pen (Humalog Pen)... CONCLUSIONS: In this study, glycemic control with BIAsp 30 and Mix25 was found to be comparable in these patients with type 2 DM. Safety profiles were similar for both regimens. Patients preferred and experienced fewer problems with the FlexPen than the Humalog Pen.
A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. [2003.11]
BACKGROUND: The accuracy and convenience of pen devices for insulin injection have improved quality of life for patients with insulin-treated diabetes mellitus (DM). Prefilled, disposable pens have the advantage of simplicity, with minimal training and attention required and no installation of new cartridges necessary. OBJECTIVE: The aim of this study was to assess patient preference, efficacy, and safety profiles of a prefilled, disposable pen (FlexPen) and conventional vial/syringe injection method for insulin injection therapy among patients with DM... CONCLUSIONS: In this trial, differences in efficacy and safety profiles between the vial/syringe and prefilled, disposable pen appeared negligible. However, more patients expressed a preference to continue use of the pen.
Clinical Trials Related to Novolog Mix 70 / 30 (Insulin Aspart Protamine Suspension / 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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