Humalog® U-100 Insulin
Adding mealtime insulin to diabetes therapy.
Consider Humalog for your patients with type 2 diabetes who:
- Need rapid-acting insulin, in addition to long-acting insulin, to manage postmeal glucose levels
- Need to add mealtime insulin injections to current basal insulin injections
- In your opinion are appropriate for this treatment plan
- Are ready to start mealtime insulin
- Want an insulin regimen that allows flexibility around meals
- Improved postmealtime glucose in adult patients when added to a basal insulin1
- Must be injected 15 minutes before or immediately after a meal
- Available in Humalog® U-100 KwikPen® and vial
Dosage of Humalog must be individualized. Humalog given by subcutaneous injection should generally be used in regimens with intermediate- or long-acting insulins.
Efficacy for type 2
Type 2 diabetes
Humalog offers improved glycemic control
When added to a basal insulin in patients with type 2 diabetes, Humalog dosed 15 minutes before or immediately after meals:
- Reduced postprandial glucose levels1
- Lowered A1C
Compared to regular human insulin, Humalog U-100 lowered 2-hour postprandial glucose excursions
*In a study of 722 patients with type 2 diabetes, the increase in serum glucose levels at 2 hours following the test meal was 53% lower for Humalog relative to regular human insulin (P<.001). Actual values for the rise in glucose were 25.4 ± 1.8 mg/dL for Humalog vs 54.0 ± 1.8 mg/dL for regular human insulin.
Select Safety Information
- Changes in insulin regimen may affect glycemic control and predispose patients to hypoglycemia and hyperglycemia. Changes should be made cautiously and the frequency of blood glucose monitoring should be increased.
Humalog U-100 self-titration dosing for your type 2 patients
The AUTONOMY study: self-titration dosing for your patients2
In the AUTONOMY study, patients initiated therapy with one injection at breakfast2
- Injections using the AUTONOMY algorithm were administered using Humalog® U-100 KwikPen3
- Carbohydrate counting was not required to adjust titration2
- Under healthcare provider direction, patients recorded their blood glucose (BG) readings, and then self-adjusted their prandial insulin based on their readings either every day or every three days2
- The initial breakfast mealtime dose was equivalent to 10% of the total daily glargine dose
Patients assessed and adjusted their own mealtime insulin2
- Following the Q1D algorithm, patients adjusted the breakfast dose daily based on the previous day’s prelunch BG reading
- When prelunch BG readings were consistently in the 85-114 mg/dL range, no further breakfast dose adjustments were required
Additional doses were added at the healthcare provider’s discretion2,4
- Once the optimal breakfast injection dose was reached and prelunch blood glucose readings were within the 85-114 mg/dL range, the HCP determined whether or not a lunch dose was needed. If additional control was required (predinner blood glucose readings ≥115 mg/dL), patients made adjustments using the same algorithm that they used for the breakfast dose
For Patients Who Used the Q1D Algorithm at 24 Weeks2,5:
- For each meal, the base unit lispro dose was equivalent to4:
- 10% of the total daily glargine dose at lunch
- 5% of the total daily glargine dose at dinner
- Lunch and dinner doses were titrated daily using the Q1D algorithm until the respective BG targets were reached
- Lunch dose adjustments were based on the previous day’s predinner BG reading
- Dinner dose adjustments were based on the previous day’s bedtime BG reading
- 61.2% of patients using the Humalog U-100 KwikPen required only 1 or 2 daily injections of mealtime insulin at study endpoint2,3,5
Consider Humalog KwikPen for your patients with type 1 diabetes who:
- Don’t want to attract attention to their disease
- Want a choice in delivery options
- Reduced postprandial glucose (PPG) levels when added to basal insulin6
- Provides flexible dosing, within 15 minutes before or immediately after a meal
- Available in a variety of delivery options, including vial, KwikPen, and infusion pump*†
In-use Humalog KwikPen should be stored at room temperature, below 86°F (30°C), and must be used within 28 days or be discarded, even if it still contains Humalog.
*Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes.
†Humalog in an external insulin pump is approved for use in children with type 1 diabetes 4 years of age and older.
Help your newly diagnosed families managing type 1 diabetes on their journey
At their most vulnerable moments of diagnosis and insulin initiation, your families managing type 1 diabetes can rely on us for starter kits and online educational resources. They can find comfort and hope in the many initiatives developed collaboratively with Disney—from cookbooks to storybooks, and a special Disney character with type 1 diabetes named Coco. And we continue our commitment throughout their journey with ongoing efforts like our summer camps for kids, scholarships for college, and awards to celebrate significant milestones of living life with diabetes without limits. Click here for details.
Efficacy for type 1
Type 1 diabetes
Humalog offers improved glycemic control
In patients with type 1 diabetes, Humalog U-100:
- Reduced PPG to a greater extent compared to regular insulin in pediatric patients; A1C did not differ between patients treated with regular insulin and those treated with Humalog7,8
- Humalog U-100 provided improved glycemic control when used in an external insulin pump
Humalog U-100 reduced postprandial blood glucose compared to regular human insulin*6
In pediatric patients with type 1 diabetes, Humalog reduced PPG to a greater extent than regular insulin; A1C did not differ between patients treated with regular human insulin and those treated with Humalog.7,8
- 61 children (2.9 to 11.4 years), mean baseline A1C value 8.4% ± 1.0%
- Diagnosed ≥12 months earlier
- Receiving human basal insulin (NPH, lente, or ultralente) plus human regular insulin (≥2 months prior to randomization)
- 3-way crossover study
- 3 treatment regimens
- A: Humalog immediately postmeal
- B: Humalog 15 minutes premeal
- C: Regular human insulin 30-45 minutes premeal
- Prestudy basal insulin regimen continued during study
- All patients received all 3 treatment regimens for 3 months per regimen in a crossover design
- Mean total daily insulin dose for all treatments was 0.8 U/kg/day
- No difference in A1C or rate of hypoglycemia among the 3 therapies
- Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes
- 3 treatment regimens
*Insulin lispro administered 15 minutes before meals compared with regular human insulin administered 30-45 minutes before meals lowered postprandial glucose after breakfast (11.7 mmol/L vs 15.0 mmol/L; P<.001) and the evening meal (8.8 mmol/L vs 10.8 mmol/L; P=.006).7 Insulin lispro administered before meals compared with regular human insulin administered 30-45 minutes before meals resulted in lower postprandial glucose after breakfast (9.7 mmol/L vs 10.6 mmol/L; P<.001) and the evening meal (8.6 mmol/L and 9.3 mmol/L, P=.003) in adolescents with type 1 diabetes.8
Humalog U-100 provided improved glycemic control when used in an external insulin pump
Humalog effectively improved A1C and blood glucose stability in patients with type 1 diabetes using insulin pumps.9,10 Humalog in an external insulin pump is approved for use in children with type 1 diabetes 4 years of age and older.
Adult pump use
In a 24-week, open-label, randomized, crossover multicenter study (N=39), using Humalog effectively improved A1C and blood glucose stability in patients using insulin pumps when compared to regular human insulin.10 The use of Humalog significantly reduced A1C and postprandial glucose levels, without increasing hypoglycemic episodes.9
Pediatric pump use
In a 16-week, open-label, parallel-group, multicenter study of children and adolescents with type 1 diabetes (N=298) aged 4 to 18 years, Humalog demonstrated comparable changes from baseline in A1C and comparable rates of hypoglycemia as insulin aspart.10
Pediatric Insulin Pump Study in Type 1 Diabetes (16 weeks; n=298)
|Baseline A1C (%)*||8.2 ± 0.8||8.0 ± 0.9|
|Change from baseline A1C (%)||-0.1 ± 0.7||-0.1 ± 0.8|
|Treatment difference in A1C,
mean (95% confidence interval)
|0.1 (-0.3, 0.1)|
|Baseline insulin dose (units/kg/24 hours)*||0.9 ± 0.3||0.9 ± 0.3|
|End-of-study insulin dose (units/kg/24 hours)||0.9 ± 0.2||0.9 ± 0.2|
|Patients with severe hypoglycemia (n, %)†||8 (8%)||19 (10%)|
*Values are mean ± SD.
†Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.
A randomized, crossover, open-label study (N=39) compared insulin lispro (IL) with regular human insulin (U-100) in patients with type 1 diabetes mellitus (mean age 39). Both were administered in an insulin pump (MiniMed 506).9,11 Each treatment was given for 3 months and then switched to the other for 3 months. In the IL cohort, the A1C decreased from 7.74 ± 0.20% at baseline to 7.11 ± 0.15% at 12 weeks of period 1. The U-100 cohort showed a decrease in A1C from 7.97 ± 0.13 to 7.88 ± 0.16%; the difference between IL and U-100 was significant (P=.01). Mean daily and 2-hour postprandial blood glucose was also significantly lower in the IL than U-100 cohort (P<.0001). The rate of hypoglycemia determined in the last 30 days of the first treatment period was 7.03 versus 7.94 events/month with IL and U-100, respectively.9 In a second study, 113 subjects (mean age 37.1 years) with type 1 diabetes mellitus were treated with IL or U-100 administered by continuous subcutaneous insulin infusion. The study was a randomized, crossover design in which each treatment was administered for 4 months. The baseline A1C was 7.24% and decreased to 6.77 ± 0.88% and 6.90 ± 0.97% in the IL and U-100 cohorts, respectively (P<.02). The postprandial glucose was reduced after breakfast (run-in 8.5 to 7.0 and 8.6 mmol/L), lunch (8.4 to 7.6 and 8.7 mmol/L), and dinner (8.2 to 7.6 and 8.3 mmol/L) in IL and U-100 cohorts, respectively (all P<.001). The total number of hypoglycemia episodes per patient was not significantly different between treatments (12.4 versus 11.0 in the IL and U-100 cohorts, respectively).12
In a 16-week, parallel-group, open-label, multicenter study, children and adolescents with type 1 diabetes were randomly assigned to insulin aspart (n=198) or insulin lispro (n=100) administered by continuous subcutaneous insulin infusion.10 Approximately two-thirds of subjects in each treatment arm were aged 12-18 years. The A1C change from baseline to endpoint for insulin aspart and insulin lispro was 0.15% and 0.05%, respectively. Insulin aspart was noninferior to insulin lispro as the 95% CI for the difference in treatment did not exceed 0.4 (95% CI -0.27 to 0.07%). In general, the incidence and rate of hypoglycemia were similar between insulin aspart and insulin lispro. At least one major hypoglycemic event occurred in 9.6% of aspart.
Important information about using Humalog U-100 in an insulin pump
Humalog U-100 should not be diluted or mixed when used in an external insulin pump. Change Humalog U-100 in the reservoir at least every 7 days. Change the infusion set and insertion site at least every 3 days.
Insulin pump or infusion set malfunction or degradation of the insulin in the pump reservoir can rapidly result in hyperglycemia and ketoacidosis. Patients should be instructed to carry alternate insulin therapy in case of pump failure.
Humalog U-100 in an external insulin pump is approved for use in patients with type 1 diabetes 4 years of age and older.
Adverse reactions associated with Humalog in patients receiving continuous subcutaneous insulin infusion: in adult patients, catheter occlusions (0.09/month), infusion-site reactions (2.6%). In children and adolescents, infusion-site reactions (21%).
Why Humalog U-100 KwikPen might be right for your patients
Humalog KwikPen is a small, lightweight, prefilled insulin pen for patients with type 2 or type 1 diabetes who want a portable device. Humalog KwikPen can be stored outside the refrigerator after first use and taken just about anywhere. Patients can carry it in their purse, backpack, or pocket because it’s the size of a marker.
In-use Humalog KwikPen should be stored at room temperature, below 86°F (30°C). Humalog KwikPen must be used within 28 days or be discarded, even if it still contains Humalog.
Humalog U-100 KwikPen can be an easy-to-use, easy-to-inject prefilled pen option*13
- Easy to set the dose*13
- Easy to see the numbers*13
- Easy to dial up and back down for dose selection
- Easy to dispense maximum dose of 60 units*13
- Allows patients or caregivers to discreetly deliver insulin
To help patients and their caregivers learn how to inject using Humalog KwikPen, please click to access the Humalog U-100 KwikPen Instructions for Use.
*Humalog KwikPen Design Validation User Study included adult male and female participants with type 1 and type 2 diabetes. Of the total 150 study participants, 56 were insulin-naïve, 42 were currently administering insulin with a vial and syringe, and 52 were experienced insulin pen users.
Pen needles for use with Humalog KwikPen
Humalog KwikPen is suitable for use with Becton Dickinson (BD) needles (sold separately and may require a separate prescription). BD offers a comprehensive line of advanced protection products. For more information about BD pen needles, visit the BD Diabetes website for healthcare professionals.
Pens and needles are for single-patient use only and should not be shared, even in healthcare facilities, as infection or disease can be spread from one person to another.
Discard needle before storing pen. A new needle should be used for each injection.
Do not withdraw insulin from the pen using a syringe.
What questions do patients most frequently ask about Humalog? Click here.
Nationwide, Humalog U-100 has better coverage* than NovoLog® and, for more insured patients, costs less†‡
Humalog U-100 is available at the lowest branded co-pay on more plans than NovoLog. The out-of-pocket costs for each patient will depend on their insurance plan, but Humalog has better coverage in the majority of cases.
For additional resources and support, click here.
*“Better coverage” means more insured patients nationwide can get Humalog U-100 KwikPen and vials at the lowest brand co-pay or better without restriction compared to NovoLog® FlexPen® and vials, respectively.
†“Costs less” means more Humalog patients are responsible for less of the cost of a drug, as measured by the amount of their co-pay/coinsurance associated with their benefit’s tier status, than NovoLog patients.
‡Applies to Humalog U-100 KwikPen and vials; comparison compiled from Commercial, Medicare, Medicaid FFS, and Managed Medicaid formulary data accurate as of 08/2016. The underlying total number of insured patients used to conclude “better coverage” and “costs less” was developed by Decision Resources Group (DRG) based on DRG’s National Managed Care Census, DRG’s Employer Vantage product, data from the Centers for Medicare & Medicaid Services, data from state Medicaid offices, and data from other publicly available sources, with assumptions to account for dependents included under reported enrolled patients. Enrollment figures may not be representative of an individual physician’s patient population.
Additional Formulary Information
- Source: Managed Markets Insight & Technology (MMIT), LLC as of 08/2016, and is subject to change without notice by a health plan or state. Please contact the plan or state for the most current information
- This information is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures
- The formulary information does not include generic medications in this therapeutic class
- Employers and employer groups may also offer additional benefit designs which may be different than described
- Co-payment amounts are subject to change by plans without notice. Lower co-payment cost alone does not necessarily reflect a cost advantage in the outcome of the condition treated because there may be other variables that affect relative costs
- The formulary information on this website is for select products that share an approved indication with Humalog U-100. Inclusion of a product does not establish clinical comparability of the products for any or all indications and should not be seen as making any claim regarding efficacy or safety
- Anderson JH Jr, Brunelle RL, Keohane P, et al; Multicenter Insulin Lispro Study Group. Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non-insulin-dependent diabetes mellitus. Arch Intern Med. 1997;157(11):1249-1255.
- Edelman SV, Liu R, Johnson J, Glass LC. AUTONOMY: the first randomized trial comparing two patient-driven approaches to initiate and titrate prandial insulin lispro in type 2 diabetes. Diabetes Care. 2014;37:2132-2140.
- Data on file, Lilly Research Laboratories: HI20140219B.
- Data on file, Lilly Research Laboratories: HI20140206A.
- Data on file, Lilly Research Laboratories: HI20140225A.
- Anderson JH Jr, Brunelle RL, Koivisto VA, et al; Multicenter Insulin Lispro Study Group. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Diabetes. 1997;46(2):265-270.
- Deeb LC, Holcombe JH, Brunelle R, et al. Insulin lispro lowers postprandial glucose in prepubertal children with diabetes. Pediatrics. 2001;108:1175-1179.
- Holcombe JH, Zalani S, Arora VK, Mast CJ; Lispro in Adolescents Study Group. Comparison of insulin lispro with regular human insulin for the treatment of type 1 diabetes in adolescents. Clin Ther. 2002;24:629-638.
- Melki V, Renard E, Lassmann-Vague V, et al. Improvement of HbA1c and blood glucose stability in IDDM patients treated with lispro insulin analog in external pumps. Diabetes Care. 1998;21(6):977-982.
- Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008;31(2):210-215.
- Zinman B, Tildesley H, Chiasson JL, Tsui E, Strack T. Insulin lispro in CSII: results of a double-blind crossover study [published correction appears in Diabetes. 1997;46(7):1239]. Diabetes. 1997;46(3):440-443.
- Renner R, Pfützner A, Trautmann M, Harzer O, Sauter K, Landgraf R; German Humalog-CSII Study Group. Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. Diabetes Care. 1999;22(5):784-788.
- Data on file, Lilly Research Laboratories: HUM20071024A.