HUMULIN R SUMMARY
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.
Published Studies Related to Humulin R (Insulin Human Subcutaneous)
Glucocorticoids fail to cause insulin resistance in human subcutaneous adipose
tissue in vivo. 
effects on insulin sensitivity in vivo... CONCLUSIONS: This study represents the first description of sc adipose insulin
Comparative pharmacokinetics and insulin action for three rapid-acting insulin
analogs injected subcutaneously with and without hyaluronidase. 
CONCLUSIONS: Coinjection of rHuPH20 with rapid-acting analogs accelerated insulin
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. 
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...
Clinical Trials Related to Humulin R (Insulin Human Subcutaneous)
Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus [Completed]
Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA)
approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase
PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of
other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and
Humulin-R in order to determine if it improves the absorption of these insulins to more
closely mimic the body's natural increase in insulin in response to a meal.
Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered HumalogŪ With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-RŪ With and Without rHuPH20 [Completed]
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD)
of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a
single subcutaneous (SC) injection of 20 units (U) with or without coadministration of
recombinant human hyaluronidase PH20 (rHuPH20).
The study hypothesizes that the time required to reach maximum insulin concentration (tmax)
when insulin is administered with rHuPH20 will be comparable or shorter than the time
required without rHuPH20.
Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM) [Completed]
This is a single-center, Phase 2, randomized, double-blind, 3-way crossover meal study in
participants with Type 2 Diabetes Mellitus (T2DM) to determine the optimum dose and compare
the pharmacokinetics (PK) and postprandial glycemic response of Humalog alone, Humalog +
recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 administered
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
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 (LevemirŪ) or aspart (NovologŪ). 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
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.
Reports of Suspected Humulin R (Insulin Human Subcutaneous) Side Effects
Blood Glucose Increased (109),
Drug Ineffective (58),
Blood Glucose Decreased (45),
Chronic Obstructive Pulmonary Disease (25),
Fall (20), more >>
Page last updated: 2014-11-30