HUMALOG- insulin lispro_injection, solution

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis. HUMALOG has been shown to be equipotent to human insulin on a molar basis. One unit of HUMALOG has the same glucose-lowering effect as one unit of regular human insulin. Studies in normal volunteers and patients with diabetes demonstrated that HUMALOG has a more rapid onset of action and a shorter duration of activity than regular human insulin when given subcutaneously. The time course of action of insulin and insulin analogs, such as HUMALOG, may vary considerably in different individuals or within the same individual. The parameters of HUMALOG activity (time of onset, peak time, and duration) should be considered only as general guidelines. The rate of insulin absorption, and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables [see Warnings and Precautions ( 5. 2 a Intravenous Administration of HUMALOG U-100 The mean blood glucose levels during the assessment phase for patients on HUMALOG therapy are summarized below in Table 4 Table 4: Mean Blood Glucose Concentrations (mg/dL) During Intravenous Infusions of HUMALOG U-100 a Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous a 0 224 +/- 16 30 205 +/- 21 60 195 +/- 20 120 165 +/- 26 180 140 +/- 26 240 123 +/- 20 300 120 +/- 27 360 122 +/- 25 The pharmacodynamics of a single 20 unit dose of HUMALOG U-200 administered subcutaneously were compared to the pharmacodynamics of a single 20 unit dose of HUMALOG U-100 administered subcutaneously in a euglycemic clamp study enrolling healthy subjects. In this study, the overall, maximum, and time to maximum glucose lowering effect were similar between HUMALOG U-200 and HUMALOG U-100. The mean area under the glucose infusion rate curves (measure of overall pharmacodynamic effect) were 125 g and 126 g for HUMALOG U-200 and HUMALOG U-100, respectively. The maximum glucose infusion rate was 534 mg/min and 559 mg/min and the corresponding median time (min, max) to maximum effect were 2. 5 h en dash 6. 5 h en dash 4. 7 h) for HUMALOG U-200 and HUMALOG U-100, respectively. Absorption and Bioavailability a HUMALOG U-100 was absorbed at a consistently faster rate than regular human insulin in healthy male volunteers given 0. 2 unit/kg at abdominal, deltoid, or femoral subcutaneous sites. After HUMALOG was administered in the abdomen, serum drug levels were higher and the duration of action was slightly shorter than after deltoid or thigh administration. Bioavailability of HUMALOG is similar to that of regular human insulin. The absolute bioavailability after subcutaneous injection ranges from 55% to 77% with doses between 0. 2 unit/kg, inclusive. The results of a study in healthy subjects demonstrated that HUMALOG U-200 is bioequivalent to HUMALOG U-100 following administration of a single 20 unit dose. The mean observed area under the serum insulin concentration-time curve from time zero to infinity was 2360 pmol hr/L and 2390 pmol hr/L for HUMALOG U-200 and HUMALOG U-100, respectively. The corresponding mean peak serum insulin concentration was 795 pmol/L and 909 pmol/L for HUMALOG U-200 and HUMALOG U-100, respectively. The median time to maximum concentration was 1. 0 hour for both formulations. Distribution Metabolism Elimination 1/2 1/2 1/2 Specific Populations The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMALOG have not been studied. Renal Impairment Hepatic Impairment.

HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

See Full Prescribing Information for important administration instructions. 4 Subcutaneous injection ( 2. 2 Administer HUMALOG registered Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Continuous subcutaneous infusion (Insulin Pump) ( 2. 2 Administer HUMALOG U-100 by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. DO NOT administer HUMALOG U-200 by continuous subcutaneous infusion. Intravenous Infusion ( 2. 2 Administer HUMALOG U-100 by intravenous infusion ONLY after dilution and under medical supervision. DO NOT administer HUMALOG U-200 by intravenous infusion. The dosage of HUMALOG must be individualized based on the route of administration and the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. 3 Do not perform dose conversion when using the HUMALOG U-100 or U-200 prefilled pens. The dose window shows the number of insulin units to be delivered and no conversion is needed. 3 Do not mix HUMALOG U-200 with any other insulin. 4 Always check insulin labels before administration [see Warnings and Precautions ( 5. 4 Inspect HUMALOG visually before use. It should appear clear and colorless. Do not use HUMALOG if particulate matter or coloration is seen. Use HUMALOG prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose. Do NOT mix HUMALOG U-100 with other insulins when administering using a continuous subcutaneous infusion pump. Do NOT transfer HUMALOG U-200 from the prefilled pen to a syringe for administration [see Warnings and Precautions ( 5. 4 Do NOT perform dose conversion when using any HUMALOG U-100 or U-200 prefilled pens. Do NOT mix HUMALOG U-200 with any other insulins. Do NOT administer HUMALOG U-200 using a continuous subcutaneous infusion pump (i. , insulin pump). Do NOT administer HUMALOG U-200 intravenously. Subcutaneous Injection: HUMALOG U-100 or U-200 Administer the dose of HUMALOG U-100 or HUMALOG U-200 within fifteen minutes before a meal or immediately after a meal by injection into the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. To reduce the risk of lipodystrophy and localized cutaneous amyloidosis, rotate the injection site within the same region from one injection to the next. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5. 2 6 During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5. 2 HUMALOG administered by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin. The HUMALOG U-100 KwikPen, HUMALOG U-100 Tempo Pen and HUMALOG U-200 KwikPen each dial in 1 unit increments and delivers a maximum dose of 60 units per injection. The HUMALOG U-100 Junior KwikPen dials in 0. 5 unit increments and delivers a maximum does of 30 units per injection. Continuous Subcutaneous Infusion (Insulin Pump): HUMALOG U-100 ONLY Do NOT administer HUMALOG U-200 using a continuous subcutaneous infusion pump. Administer HUMALOG U-100 by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. 2 Follow healthcare professional recommendations when setting basal and meal time infusion rate. Do NOT dilute or mix HUMALOG U-100 when administering by continuous subcutaneous infusion. Change HUMALOG U-100 in the pump reservoir at least every 7 days. Change the infusion sets and the infusion set insertion site at least every 3 days. Do NOT expose HUMALOG U-100 in the pump reservoir to temperatures greater than 98. Use HUMALOG U-100 in pump systems suitable for insulin infusion [see Patient Counseling Information ( 17 Intravenous Administration: HUMALOG U-100 ONLY Do NOT administer HUMALOG U-200 intravenously. Dilute HUMALOG U-100 to concentrations from 0. 1 unit/mL to 1. 0 unit/mL using 0. 9% Sodium Chloride Injection, USP. Administer HUMALOG U-100 intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions ( 5. 4 Individualize and adjust the dosage of HUMALOG based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i. , macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5. 7 Do NOT perform dose conversion when using any HUMALOG U-100 or U-200 prefilled pens. Dosage adjustment may be needed when HUMALOG is coadministered with certain drugs [see Drug Interactions ( 7 Dosage adjustment may be needed when switching from another insulin to HUMALOG [see Warnings and Precautions ( 5. 2 Instructions for Mixing with Other Insulins HUMALOG U-100 subcutaneous injection route HUMALOG U-100 may be mixed with NPH insulin preparations ONLY If HUMALOG U-100 is mixed with NPH insulin, HUMALOG U-100 should be drawn into the syringe first. Injection should occur immediately after mixing. HUMALOG U-100 continuous subcutaneous infusion route (Insulin Pump) Do NOT mix HUMALOG U-200 subcutaneous injection route Do NOT mix.

Adverse reactions associated with HUMALOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. 1 To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www. gov/medwatch. Observed with HUMALOG U-100 The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5. 3 Hypokalemia [see Warnings and Precautions ( 5. 6 Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared with those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The frequencies of Treatment-Emergent Adverse Events during HUMALOG clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below. Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 Diabetes Mellitus (adverse events with frequency >=5%) Events, n (%) Lispro Regular human insulin Flu syndrome 28 (34. 6) Pharyngitis 27 (33. 7) Rhinitis 20 (24. 1) Headache 24 (29. 1) Pain 16 (19. 3) Cough increased 14 (17. 4) Infection 11 (13. 9) Nausea 5 (6. 1) Accidental injury 7 (8. 6) Surgical procedure 5 (6. 0) Fever 5 (6. 6) Abdominal pain 6 (7. 1) Asthenia 6 (7. 1) Bronchitis 6 (7. 0) Diarrhea 7 (8. 8) Dysmenorrhea 5 (6. 0) Myalgia 6 (7. 8) Urinary tract infection 5 (6. 7) Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus (adverse events with frequency >=5%) Events, n (%) Lispro Regular human insulin Headache 83 (11. 3) Pain 77 (10. 0) Infection 72 (10. 6) Pharyngitis 47 (6. 2) Rhinitis 58 (8. 6) Flu syndrome 44 (6. 2) Surgical procedure 53 (7. 8) Insulin initiation and intensification of glucose control Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy. Lipodystrophy Long-term use of insulin, including HUMALOG, can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy [see Dosage and Administration ( 2. 2 Weight gain Weight gain can occur with insulin therapy, including HUMALOG, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. Peripheral Edema Insulin, including HUMALOG, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII) em dash HUMALOG U-100 In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions and infusion site reactions were similar for HUMALOG U-100 and regular human insulin treated patients ( see Table 3 Table 3: Catheter Occlusions and Infusion Site Reactions HUMALOG U-100 Regular human insulin Catheter occlusions/month 0. 10 Infusion site reactions 2. 6% (1/38) 2. 6% (1/39) In a randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes, adverse event reports related to infusion-site reactions were similar for insulin lispro and insulin aspart (21% of 100 patients versus 17% of 198 patients, respectively). In both groups, the most frequently reported infusion site adverse events were infusion site erythema and infusion site reaction. Allergic Reactions Local Allergy Systemic Allergy In controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving regular human insulin (n=2969) and 30 patients receiving HUMALOG (n=2944). Localized reactions and generalized myalgias have been reported with injected metacresol, which is an excipient in HUMALOG [see Contraindications ( 4 Antibody Production In large clinical trials with patients with type 1 (n=509) and type 2 (n=262) diabetes mellitus, anti-insulin antibody (insulin lispro-specific antibodies, insulin-specific antibodies, cross-reactive antibodies) formation was evaluated in patients receiving both regular human insulin and HUMALOG (including patients previously treated with human insulin and naive patients). As expected, the largest increase in the antibody levels occurred in patients new to insulin therapy. The antibody levels peaked by 12 months and declined over the remaining years of the study. These antibodies do not appear to cause deterioration in glycemic control or necessitate an increase in insulin dose. There was no statistically significant relationship between the change in the total daily insulin dose and the change in percent antibody binding for any of the antibody types. HUMALOG U-100 The following additional adverse reactions have been identified during post-approval use of HUMALOG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Medication errors in which other insulins have been accidentally substituted for HUMALOG have been identified during post-approval use [see Patient Counseling Information ( 17 Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

HUMALOG is contraindicated: during episodes of hypoglycemia in patients who are hypersensitive to HUMALOG or to any of its excipients. Do not use during episodes of hypoglycemia. ( 4 Do not use in patients with hypersensitivity to HUMALOG or any of its excipients.

Pediatrics: 8. 4 Risk Summary The limited available data with HUMALOG in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) (see Clinical Considerations) Pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. No adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. No adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0. 2 times the human subcutaneous dose of 1 unit/kg/day (see Data) The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. However, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups. Animal Data In a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0. 8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through Gestation Day 19. There were no adverse effects on female fertility, implantation, or fetal viability and morphology. However, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter. In an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0. 75 unit/kg/day (0. 2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on Gestation days 7 through 19. There were no adverse effects on fetal viability, weight, and morphology at any dose. Risk Summary There are no data on the presence of HUMALOG in human milk, the effects on the breastfed infant, or the effect on milk production. One small published study reported that exogenous insulin was present in human milk. However, there is insufficient information to determine the effects of HUMALOG on the breastfed infant and no available information on the effects of HUMALOG on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin, any potential adverse effects on the breastfed child from HUMALOG or from the underlying maternal condition. HUMALOG is approved for use in children for subcutaneous daily injections [see Clinical Studies ( 14 As in adults, the dosage of HUMALOG must be individualized in pediatric patients based on metabolic needs and results of frequent monitoring of blood glucose. Of the total number of subjects (n=2834) in eight clinical studies of HUMALOG, twelve percent (n=338) were 65 years of age or over. The majority of these had type 2 diabetes. HbA 1c Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent HUMALOG dose adjustment and more frequent blood glucose monitoring [see Clinical Pharmacology ( 12. 3 Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent HUMALOG dose adjustment and more frequent blood glucose monitoring [see Clinical Pharmacology ( 12.

Drugs that Affect Glucose Metabolism: 7. 3 Anti-Adrenergic Drugs (e. , beta-blockers, clonidine, guanethidine, and reserpine): 5. 4 The risk of hypoglycemia associated with HUMALOG use may be increased when co-administered with antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e. , octreotide). Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs. The glucose lowering effect of HUMALOG may be decreased when co-administered with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e. , epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones. The glucose lowering effect of HUMALOG may be increased or decreased with co-administered with beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. The signs and symptoms of hypoglycemia [see Warnings and Precautions ( 5.

OVERDOSAGE
Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.
NONCLINICAL TOXICOLOGY
Standard 2-year carcinogenicity studies in animals have not been performed. In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area). Insulin lispro did not produce important target organ toxicity including mammary tumors at any dose. Insulin lispro was not mutagenic in the following genetic toxicity assays: bacterial mutation, unscheduled DNA synthesis, mouse lymphoma, chromosomal aberration and micronucleus assays. Male fertility was not compromised when male rats given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0. 8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area) for 6 months were mated with untreated female rats. In a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0. 8, and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose. In standard biological assays in fasted rabbits, 0. 2 unit/kg of insulin lispro injected subcutaneously had the same glucose-lowering effect and had a more rapid onset of action as 0. 2 unit/kg of regular human insulin.
CLINICAL STUDIES
The safety and efficacy of HUMALOG U-100 were studied in children, adolescent, and adult patients with type 1 diabetes (n=789) and adult patients with type 2 diabetes (n=722). A 12-month, randomized, parallel, open-label, active-controlled study was conducted in patients with type 1 diabetes to assess the safety and efficacy of HUMALOG (n=81) compared with Humulin registered registered registered Table 5: Type 1 Diabetes Mellitus en dash Adults and Adolescents a b Treatment Duration 12 months HUMALOG Humulin R N 81 86 Baseline HbA 1c a 8. 7 Change from baseline HbA 1c a -0. 1 Treatment Difference in HbA 1c 0. 8) Baseline short-acting insulin dose (units/kg/day) 0. 1 End-of-Study short-acting insulin dose (units/kg/day) 0. 1 Change from baseline short-acting insulin dose (units/kg/day) 0. 1 Baseline Body weight (kg) 72 +/- 12. 7 71 +/- 11. 3 Weight change from baseline (kg) 1. 6 Patients with severe hypoglycemia (n, %) b 14 (17%) 18 (21%) A 6-month randomized, crossover, open-label, active-controlled study was conducted in insulin-treated patients with type 2 diabetes (n=722) to assess the safety and efficacy of HUMALOG for 3 months followed by Humulin R for 3 months or the reverse sequence. HUMALOG was administered by subcutaneous injection immediately before meals and Humulin R was administered 30 to 45 minutes before meals. Humulin registered 2 1c see Table 6 Table 6: Type 2 Diabetes Mellitus em dash Adults a b End point Baseline HUMALOG Humulin R HbA 1c a 8. 4 Change from baseline HbA 1c a em dash -0. 3 Short-acting insulin dose (units/kg/day) a 0. 2 Change from baseline short-acting insulin dose (units/kg/day) a em dash 0. 1 Body weight (kg) a 80 +/- 15 81 +/- 15 81 +/- 15 Weight change from baseline em dash 0. 6 Patients with severe hypoglycemia (n, %) b em dash 15 (2%) 16 (2%) An 8-month, crossover study of adolescents with type 1 diabetes (n=463), aged 9 to 19 years, compared two subcutaneous multiple-dose treatment regimens: HUMALOG or Humulin R, both administered with Humulin N (NPH human insulin) as the basal insulin. HUMALOG achieved glycemic control comparable to Humulin R, as measured by HbA 1c see Table 7 1c Table 7: Pediatric Subcutaneous Administration of HUMALOG in Type 1 Diabetes a b End point Baseline HUMALOG Humulin R HbA 1c a 8. 6 Change from baseline HbA 1c a em dash 0. 1 Body weight (kg) a 59. 9 Weight change from baseline (kg) a em dash 2. 0 Patients with severe hypoglycemia (n, %) b em dash 5 (1. 1%) Diabetic ketoacidosis (n, %) em dash 11 (2. 9%) To evaluate the administration of HUMALOG U-100 via external insulin pumps, two open-label, crossover design studies were performed in patients with type 1 diabetes. One study involved 39 patients, ages 19 to 58 years, treated for 24 weeks with HUMALOG or regular human insulin. After 12 weeks of treatment, the mean HbA 1c 1c A randomized, 16-week, open-label, parallel design, study of children and adolescents with type 1 diabetes (n=298) aged 4 to 18 years compared two subcutaneous infusion regimens administered via an external insulin pump: insulin aspart (n=198) or HUMALOG U-100 (n=100). These two treatments resulted in comparable changes from baseline in HbA 1c see Table 8 Table 8: Pediatric Insulin Pump Study in Type 1 Diabetes (16 weeks; n=298) a b HUMALOG Aspart N 100 198 Baseline HbA 1c a 8. 9 Change from Baseline HbA 1c -0. 8 Treatment Difference in HbA 1c 0. 1) Baseline insulin dose (units/kg/24 hours) a 0. 3 End-of-Study insulin dose (units/kg/24 hours) a 0. 2 Patients with severe hypoglycemia (n, %) b 8 (8%) 19 (10%) Diabetic ketoacidosis (n, %) 0 (0) 1 (0. 5%) Baseline body weight (kg) a 55. 7 Weight Change from baseline (kg) a 1.

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