HUMULIN R SUMMARY
STORAGE
Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for human insulin production. Humulin R (U-500) consists of zinc-insulin crystals dissolved in a clear fluid. Humulin R (U-500) is a sterile solution and is for subcutaneous injection. It should not be used intravenously or intramuscularly. The concentration of Humulin R (U-500) is 500 units/mL.Each milliliter contains 500 units of biosynthetic human insulin, 16 mg glycerin, 2.5 mg Metacresol as a preservative, and zinc-oxide calculated to supplement endogenous zinc to obtain a total zinc content of 0.017 mg/100 units. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.
HUMULIN R (insulin human SUBCUTANEOUS) is indicated for the following:
Humulin R (U-500) is especially useful for the treatment of diabetic patients with marked insulin resistance (daily requirements more than 200 units), since a large dose may be administered subcutaneously in a reasonable volume.
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NEWS HIGHLIGHTS
Published Studies Related to Humulin R (Insulin Human Subcutaneous)
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 Humulin R (Insulin Human Subcutaneous)
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes [Completed]
This will be a randomized, open label, parallel group, multicenter study. There will be two
phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of
regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients
with type 2 diabetes who have either been on a prior regimen of insulin for less than 6
months and were taking less than 50 U total of insulin per day OR are candidates for the
initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore
further intensification of diabetes regimens in patients failing to achieve HbA1c <=6. 5% at
Week 24.
Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes [Completed]
This trial is conducted in Europe and the United States of America (USA).
The purpose of this study is to test whether insulin detemir is a safe and at least as
effective alternative to insulin glargine for the control of blood glucose in basal/bolus
therapy in patients with type I diabetes.
Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes [Completed]
This trial is conducted in Europe and the United States of America (USA).
The purpose of this study is to test whether insulin detemir is a safe and at least as
effective alternative to insulin glargine for the control of blood glucose in basal/bolus
therapy in patients with type 2 diabetes.
32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus [Completed]
To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of
treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as
mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as
mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety
of both treatments, evaluated through hypoglycemic rates.
Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose [Active, not recruiting]
The main purpose of the study is to investigate the reason for the reduced number of
hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin
Aspart at meals together with NPH insulin mornings and evenings, and when, in another period
of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and
when the patients in both periods simultaneously take extra insulin at meals if high blood
glucose values are found before meals.
Reports of Suspected Humulin R (Insulin Human Subcutaneous) Side Effects
Blood Glucose Increased (109),
Drug Ineffective (58),
Blood Glucose Decreased (45),
Hypoglycaemia (33),
Chronic Obstructive Pulmonary Disease (25),
Hospitalisation (24),
Emphysema (23),
Amnesia (22),
Bedridden (20),
Fall (20), more >>
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Page last updated: 2013-02-10
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