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Novolin R (Insulin Human) - Summary

 
 



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.

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Clinical Trials Related to Novolin R (Insulin Human)

Comparison Study of Insulin Glargine and NPH Insulin [Enrolling by invitation]
This study will compare the safety, effectiveness, and cost of two different types of long-acting insulin.

Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics [Terminated]
This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based human insulin products (marketed in USA) in type 1 diabetics. There are two phases of the study, which are as follows: 1. Phase 1 is a comparative phase in which there will be 2 arms (which are described in the section below). 2. Phase 2 is a follow up phase only applicable to Wosulin Arm. The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately 28 weeks for the patients enrolled in the comparator arm. Two hundred and forty two patients will be enrolled considering an estimated dropout rate of 15% for a sample size of approximately 105 evaluable patients per arm. The total planned enrollment period for this study is approximately 3 months (90 days).

Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes [Completed]
The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty liver disease (or NAFLD, a common condition in T2DM; Cusi K, Current Diabetes Reports 2009) has not been systematically studied before, and in particular, never when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). This study was to determine the effect on hepatic steatosis and insulin secretion/action of lowering the fasting plasma glucose (FPG) to target with once daily basal insulin detemir alone or combining insulin detemir with premeal insulin aspart in patients with uncontrolled type 2 diabetes mellitus (T2DM). In the first 3 months the investigators will optimize metabolic control in all patients with intensive basal (bedtime) detemir insulin aiming at a normal fasting plasma glucose. After this treatment period, patients will be randomized in the second 3 months in a 2: 1 ratio to insulin detemir or detemir plus aspart. The investigators propose that insulin will improve day-long glycemic control and A1c, reduce hepatic steatosis (NAFLD) (primary endpoint) and insulin secretion/sensitivity being well tolerated while causing minimal weight gain and hypoglycemia (secondary endpoints). The study will allow to assess if there is an additional benefit of adding pre-meal rapid-acting insulin aspart to basal insulin to these endpoints.

Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia [Recruiting]
No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective:

- Group 1: Intermediate-acting (NPH) insulin at breakfast

- Group 2: Short-acting insulin (regular or aspart) before meals

- Group 3: Insulin glargine at breakfast

Question/Hypothesis: Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?

Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome [Suspended]
The study aims to demonstrate that a simple intravenous insulin algorithm can be implemented in Latin America and will result in safe and better glucose control in patients with Acute Coronary Syndrome (ACS) compared with SC insulin.

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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 >>


Page last updated: 2013-02-10

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