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)
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.
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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