NOVOLIN R SUMMARY
Novolin ® R Regular, Human Insulin Injection (rDNA origin) USP is a polypeptide hormone structurally identical to natural human insulin and is produced by rDNA technology, utilizing Saccharomyces cerevisiae (bakers' yeast) as the production organism.
Novolin R is indicated for subcutaneous administration for the treatment of patients with diabetes mellitus, for the control of hyperglycemia. Treatment with Novolin R is as an adjunct to diet and exercise for lowering blood glucose in patients with Type 1 diabetes or in patients with Type 2 diabetes for whom oral antidiabetic therapy is inadequate.
Novolin R may be administered intravenously under proper medical supervision in a clinical setting for glycemic control. (See DOSAGE AND ADMINISTRATION and RECOMMENDED STORAGE.)
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NEWS HIGHLIGHTS
Published Studies Related to Novolin R (Insulin Human)
Phase IV study comparing diurnal glycemic profile following the administration of
2 NPH plus regular human DNA recombinant insulin regimens in type 1 diabetes
mellitus (T1DM) adult patients. [2012]
Intensive insulin therapy (IIT) based on multiple daily injections of long plus
rapid-acting insulin has been demonstrated to reduce mortality and morbidity
associated with chronic hyperglycemia in T1DM patients. The objective of this
study was to assess and compare the postprandial glycemic profile over a diurnal
12 h-period produced by the administration of a new NPH plus regular human DNA
recombinant IIT (test regimen) relative to the reference IIT in T1DM patients...
Slow-release insulin in cystic fibrosis patients with glucose intolerance: a randomized clinical trial. [2011.11.08]
Minicucci L, Haupt M, Casciaro R, De Alessandri A, Bagnasco F, Lucidi V, Notarnicola S, Lorini R, Bertasi S, Raia V, Cialdella P, Haupt R. Slow-release insulin in cystic fibrosis patients with glucose intolerance: a randomized clinical trial... Further studies are necessary to test glargine at higher dosage and for a longer follow-up period.
High-Dose Insulin Therapy Reduces Postoperative Liver Dysfunction and Complications in Liver Resection Patients through Reduced Apoptosis and Altered Inflammation. [2011.10.26]
Context:An exaggerated inflammatory response in patients undergoing major liver resection coupled with poor nutrition diminishes liver regenerative capacity and increases the risk of postoperative complications.Objectives:Our objective was to evaluate the biological context leading to better clinical outcomes in patients undergoing liver resection coupled with hyperinsulinemic-normoglycemic clamp vs...
Intramyocellular lipid content and insulin sensitivity are increased following a short-term low-glycemic index diet and exercise intervention. [2011.09]
The relationship between intramyocellular (IMCL) and extramyocellular lipid (EMCL) accumulation and skeletal muscle insulin resistance is complex and dynamic. We examined the effect of a short-term (7-day) low-glycemic index (LGI) diet and aerobic exercise training intervention (EX) on IMCL and insulin sensitivity in older, insulin-resistant humans...
Treatment with Anakinra improves disposition index but not insulin sensitivity in nondiabetic subjects with the metabolic syndrome: a randomized, double-blind, placebo-controlled study. [2011.07]
CONTEXT: Obesity induces low-grade inflammation that may promote the development of insulin resistance. IL-1 is one of the key inflammatory factors. OBJECTIVE: The objective of the study was to demonstrate improvement of insulin sensitivity by blocking IL-1... CONCLUSIONS: Our results suggest that anakinra does not improve insulin sensitivity in obese, insulin-resistant, nondiabetic subjects.
Clinical Trials Related to Novolin R (Insulin Human)
Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects [Recruiting]
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with
regard to its total and to its maximum serum insulin concentrations.
Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes [Recruiting]
Patients with diabetes treated with insulin often gain weight, which may deter patients from
adhering to insulin treatment. Detemir is one type of long acting insulin approved by the
Food and Drug Administration for use in people with diabetes. It is similar to other long
acting insulins (NPH, glargine) except that it has been associated with less weight gain
compared to other types of insulin. The reasons for this are still unclear. One possibility
is that detemir insulin acts differently than do other insulins in affecting how diabetic
patients eat meals. The purpose of this study is to determine whether appetite and calories
eaten during a meal are affected by the type of insulin used to treat diabetes. This is a
pilot study which means we are gathering preliminary information to determine if a larger
study can be done.
Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes [Recruiting]
The purpose of this study is to determine whether there is a difference in blood sugar
control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin
injections incorporating a new long acting insulin analogue (detemir) compared to children
using their current three times a day insulin injections (with intermediate and rapid acting
insulin).
Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin [Not yet recruiting]
The purpose of this study is to compare the use of insulin glargine plus insulin lispro to
human regular insulin for treatment of hyperglycemia in the hospital setting in patients
without known prior history of diabetes.
Insulin Detemir Action in Cerebro [Recruiting]
The aim of this study is to test the hypothesis that subcutaneous administration of insulin
detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose
metabolism and/or cerebral blood flow in brain regions associated with appetite regulation,
to account for the reported difference in weight.
Reports of Suspected Novolin R (Insulin Human) Side Effects
Hypoglycaemia (17),
Blood Glucose Increased (12),
Anti-Insulin Antibody Positive (9),
Product Quality Issue (8),
Diabetes Mellitus Inadequate Control (7),
Hyperglycaemia (5),
Convulsion (5),
Hypoglycaemic Unconsciousness (5),
Intentional Overdose (4),
Blood Glucose Decreased (4), more >>
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