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Indication for Humalog Brand of Insulins

Humalog® is used to treat people with diabetes for the control of blood sugar. Humalog® Mix75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection) and Humalog® Mix50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection) are used to treat adults with diabetes for the control of high blood sugar.

Do not take Humalog if your blood sugar is too low (hypoglycemia) or if you are allergic to insulin lispro or any of the ingredients in Humalog.

Important Safety Information for Humalog Brand of Insulins

What is the most important information I should know about Humalog, Humalog 200 units/mL KwikPen, Humalog Mix75/25, and Humalog Mix50/50?

  • Do not share your Humalog, Humalog Mix75/25, or Humalog Mix50/50 KwikPen, cartridges, reusable pen compatible with Lilly 3 mL cartridges, or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
  • Humalog 200 units/mL KwikPen contains 2 times as much insulin (200 units/mL) in 1 mL as standard insulin (100 units/mL).
  • The Humalog contained in the Humalog U-200 KwikPen should ONLY be injected with the Humalog U-200 KwikPen. Do NOT withdraw Humalog U-200 from the pen using a syringe. It could result in an overdose causing severe low blood sugar which may put your life in danger.
  • Do not change the insulin you use without talking to your healthcare provider. Changes may make you more likely to experience low or high blood sugar. Changes should be made cautiously under the supervision of your healthcare provider.
  • Test your blood sugar levels as your healthcare provider instructs.
  • Your insulin dose may need to change because of illness, stress, other medicines you take, change in diet, or change in physical activity or exercise.
  • When used in a pump, do not mix or dilute Humalog U-100 with any other insulin or liquid. Do NOT use Humalog U-200, Humalog Mix75/25 or Humalog Mix50/50 in a pump.

Who should not take Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • Do not take these insulins if your blood sugar is too low (hypoglycemia) or if you are allergic to insulin lispro or any of the ingredients in these insulins.

Before using Humalog, Humalog Mix75/25, or Humalog Mix50/50, what should I tell my healthcare providers?

  • About all of your medical conditions, including liver, kidney, or heart failure or other heart problems.
  • If you are pregnant, planning to become pregnant, or are breastfeeding.
  • About all the medicines you take, including prescription (especially ones commonly called TZDs [thiazolidinediones]) and nonprescription medicines, vitamins, and herbal supplements.

How should I use Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • These insulins start working faster than other insulins that contain regular human insulin. You should take Humalog within fifteen minutes before eating or right after eating a meal. You should take Humalog Mix75/25 and Humalog Mix50/50 within fifteen minutes before eating.
  • Always make sure that you receive the correct type of insulin from the pharmacy.
  • Do not use Humalog if it is cloudy, colored, or has solid particles or clumps in it.
  • Do not use Humalog Mix75/25 or Humalog Mix50/50 if they have solid particles or clumps in them. Humalog Mix75/25 and Humalog Mix50/50 should be mixed carefully before each use and should be cloudy or milky after mixing.
  • Do not mix Humalog U-100 with insulin other than NPH when using a syringe. Do not mix or dilute Humalog U-100 when used in a pump.
  • Never mix Humalog Mix75/25 or Humalog Mix50/50 in the same syringe with other insulin products. Never use Humalog U-200, Humalog Mix75/25 or Humalog Mix50/50 in a pump.
  • Inject your insulin under your skin (subcutaneously). Never inject into a vein or muscle. Change (rotate) your injection site with each dose. Make sure you inject the correct insulin and dose.
  • Do not re-use needles. Always use a new needle for each injection. Re-use of needles can cause you to receive the wrong dose of Humalog and result in infection.
  • Do not drive or operate heavy machinery until you know how Humalog affects you. Do not use alcohol while using Humalog.

What are the possible side effects of Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Low blood sugar is the most common side effect. There are many causes of low blood sugar, including taking too much insulin. It is important to treat it quickly. You can treat mild to moderate low blood sugar by drinking or eating a quick source of sugar right away. Symptoms may be different for each person. Be sure to talk to your healthcare provider about low blood sugar symptoms and treatment.
  • Severe life-threatening allergic reactions (whole-body reactions) can happen. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.
  • Humalog, Humalog Mix75/25, and Humalog Mix50/50 can cause life-threatening low potassium in your blood (hypokalemia), which can cause severe breathing problems, irregular heartbeat, and death.
  • Serious side effects can include swelling of your hands and feet and heart failure when taking certain pills called thiazolidinediones or “TZDs” with Humalog, Humalog Mix75/25, or Humalog Mix50/50. This may occur in some people even if they have not had heart problems before. Tell your healthcare provider if you have shortness of breath, swelling of your ankles or feet, or sudden weight gain, which may be symptoms of heart failure. Your healthcare provider may need to adjust or stop your treatment with TZDs, Humalog, Humalog Mix75/25, or Humalog Mix50/50.
  • Failure of your insulin pump or infusion set or degradation of the insulin in the pump can cause hyperglycemia and ketoacidosis. Always carry an alternate form of insulin administration in case of pump failure.
  • The most common side effects of Humalog include low blood sugar, allergic reactions, including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy), itching, and rash. These are not all of the possible side effects. Ask your healthcare provider for more information or for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

For additional information talk to your healthcare providers and please click to access Humalog Full Prescribing Information, Humalog U-100 Patient Prescribing Information, Humalog U-200 KwikPen Patient Prescribing Information, Humalog Mix75/25 Full Prescribing Information and Patient Prescribing Information, and Humalog Mix50/50 Full Prescribing Information and Patient Prescribing Information.

Please see Instructions for Use included with your pen.

HI U200 BOI CON ISI 26MAY2015

Humalog® and Humalog® KwikPen® are registered trademarks of Eli Lilly and Company, its subsidiaries, or affiliates, and are available by prescription only.

Humalog® Mix75/25, Humalog® Mix50/50, Humalog® Mix75/25 KwikPen®, and Humalog® Mix50/50 KwikPen® are trademarks of Eli Lilly and Company and are available by prescription only.

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Indication for Humalog Brand of Insulins

Humalog® is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog® Mix75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection) and Humalog® Mix50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection) are indicated in the treatment of adults with diabetes mellitus for the control of hyperglycemia.

Important Safety Information for Humalog Brand of Insulins

Contraindications

  • Humalog, Humalog Mix75/25, and Humalog Mix50/50 are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to Humalog or any of its excipients.

Warnings and Precautions

  • Never Share a Humalog KwikPen, Humalog Mix75/25 KwikPen, or Humalog Mix50/50 KwikPen, Cartridge, Reusable Pen Compatible with Lilly 3 mL Cartridges, or Syringe Between Patients: Humalog, Humalog Mix75/25, and Humalog Mix50/50 KwikPens, cartridges, and reusable pens compatible with Lilly 3 mL cartridges must never be shared between patients, even if the needle is changed. Patients using Humalog, Humalog Mix75/25, or Humalog Mix50/50 vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Changes in Insulin Regimen: Changes may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased.
  • Hypoglycemia: Severe hypoglycemia may be life threatening and can cause seizures or death. Hypoglycemia is the most common adverse reaction of Humalog, Humalog Mix75/25, and Humalog Mix50/50. The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. Hypoglycemia can happen suddenly and symptoms may vary for each person and may change over time. Early warning symptoms of hypoglycemia may be different or less pronounced under conditions such as long-standing diabetes, diabetic nerve disease, use of medications such as beta-blockers, or in patients who experience recurrent hypoglycemia. These situations may result in severe hypoglycemia and possibly loss of consciousness prior to the patient’s awareness of hypoglycemia.
  • Timing of hypoglycemia usually reflects the time-action profile of administered insulins which may vary in different individuals or at different times in the same individual. Other factors such as changes in food intake, injection site, exercise, and concomitant medications may increase the risk of hypoglycemia.
  • Educate patients to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients with reduced symptomatic awareness, increased frequency of blood glucose monitoring is recommended. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
  • Hypoglycemia Due to Medication Errors: Instruct patients to always check the insulin label before each injection to avoid medication errors.
  • Humalog U-200 should not be transferred from the Humalog KwikPen to a syringe as overdose and severe hypoglycemia can occur.
  • Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Humalog, Humalog Mix75/25, and Humalog Mix50/50. If hypersensitivity reactions occur, discontinue the use of insulin and treat per standard of care until signs and symptoms resolve.
  • Hypokalemia: Hypokalemia may be life threatening. Insulins, including Humalog, Humalog Mix75/25, and Humalog Mix50/50, cause a shift in potassium from the extracellular to intracellular space possibly leading to hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia (eg, patients using potassium-lowering medications or medications sensitive to serum potassium concentrations).
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including Humalog, Humalog Mix75/25, and Humalog Mix50/50. This may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist.
  • Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Malfunction of the insulin pump device, infusion set, or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Drug Interactions

  • Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required.

Adverse Reactions

  • Adverse reactions associated with Humalog include hypoglycemia, hypokalemia, allergic reactions, injection-site reactions, lipodystrophy, pruritus, rash, weight gain, and peripheral edema.

Use in Specific Populations

  • Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established.

Dosage and Administration

  • Humalog should be given within 15 minutes before or immediately after a meal.
  • Humalog Mix75/25 and Humalog Mix50/50 should be given within 15 minutes before a meal.
  • Humalog U-100 can be administered intravenously under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. Do NOT administer Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 intravenously.
  • Humalog U-100 for subcutaneous injection should only be mixed with NPH insulin. If Humalog U-100 is mixed with NPH insulin, Humalog should be drawn into the syringe first. Injection should occur immediately after mixing. Do NOT mix Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 in a syringe with any other insulin.
  • 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. Do NOT use Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 in a subcutaneous insulin infusion pump.
  • Do NOT perform dose conversion when using either the Humalog U-100 or Humalog U-200 KwikPens. The dose window shows the number of insulin units to be delivered and no conversion is needed.

Please click to access Humalog Full Prescribing Information, Humalog Mix75/25 Full Prescribing Information, and Humalog Mix50/50 Full Prescribing Information.

Please see Instructions for Use included with the pen.

HI BOI U200 HCP ISI 26MAY2015

Humalog® and Humalog® KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates, and are available by prescription only.

Humalog® Mix75/25, Humalog® Mix50/50, Humalog® Mix75/25 KwikPen®, and Humalog® Mix50/50 KwikPen® are trademarks of Eli Lilly and Company and are available by prescription only.

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U-100 Dosing and
Self-titration

Initiating mealtime insulin

AUTONOMY demonstrated that patient self-titration using Humalog® U-100 KwikPen® can be effective1,2

Thought leaders discuss the AUTONOMY study

These short videos, featuring well-respected leaders from the diabetes community, provide an insightful look at the AUTONOMY study, the study’s implications, and a step-by-step tutorial for the Humalog Self-titration Algorithm.

The AUTONOMY Study

AUTONOMY study author Dr. Steven Edelman reviews the study and discusses how the findings may help patients with type 2 diabetes and the healthcare providers who treat them.

AUTONOMY Primary Care

Professor and primary care physician Dr. Charles Shaefer discusses the practical application of the Humalog Self-titration Algorithm in the primary care setting.

Starting a Patient on the Humalog Self-titration Algorithm

Learn how to help your patient start mealtime insulin using the Humalog Self-titration Algorithm.

Self-titration of Humalog U-100 using the Q1D algorithm may help your patients be more engaged in their therapy1

  • Identify a candidate that you feel comfortable allowing to self-titrate and would like to initiate mealtime insulin starting with one daily injection
  • Show your patient how to utilize tools, such as the logbook, to help them track their blood sugar and make adjustments

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.

For more information, contact your Lilly Sales Representative or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).

Q1D algorithm

Q1D algorithm1

Using the Q1D algorithm, patients self-titrated every day based on premeal or bedtime blood glucose (BG) readings, respectively, from the previous day. For example, when adjusting the prebreakfast dose, patients used their prelunch readings from the previous day. The premeal target BG was 85-114 mg/dL. If the patient had a BG reading of ≥115 mg/dL, the patient increased the lispro dose by 1 unit/day until the target was reached. For a BG reading of 56-84 mg/dL, the dose was decreased by 1 unit, and for a reading of <56 mg/dL, the dose was decreased by 2 units.

Q3D algorithm

Q3D algorithm1

Using the Q3D algorithm, patients self-titrated every 3 days based on the median (middle) BG readings from the 3 days before.1 Accordingly, to adjust the prebreakfast dose, the patient used the median prelunch BG reading from the past 3 days. If the median reading was 85-114 mg/dL, there was no change in lispro dose. For median 115-144 mg/dL, the patient increased the dose by 2 units. For median ≥145 mg/dL, the dose was increased by 4 units. For median 56-84 mg/dL, the dose was decreased by 2 units. For median <56 mg/dL, the dose was decreased by 4 units.

AUTONOMY study design1

AUTONOMY study design chart

The AUTONOMY study was a 24-week, multicenter, randomized, open-label, parallel trial of adult patients (N=1106) with type 2 diabetes inadequately controlled on basal insulin, conducted in primary care and endocrinology settings, to compare 2 patient self-titration algorithms for initiating and adjusting prandial insulin lispro.

AUTONOMY consisted of 2 identical studies (Study A and Study B) using the same protocol to compare the primary outcome of change in A1C from baseline after 24 weeks between a daily (Q1D) or 3-day (Q3D) algorithm. Interventions consisted of adding lispro sequentially by 1, 2, or 3 mealtime injections to their baseline glargine. Initial lispro dose began at breakfast.

The primary and secondary objectives were evaluated for the overall population and subjects ≥65 years old.

In the AUTONOMY study, patients began mealtime insulin with one injection at breakfast1

Is your patient a candidate for self-titration with Humalog U-100 KwikPen?

The patients in the AUTONOMY study1:

  • Had type 2 diabetes
  • Had uncontrolled A1C
  • Were on ≥20 units of basal insulin once daily and were on 1 or more oral antidiabetes drugs (OADs)
  • Were aged 18-85
  • Had BMI <45 kg/m2

Overview of the AUTONOMY study

In the AUTONOMY study, mealtime insulin lispro therapy by self-titration was effectively initiated with a single breakfast injection and adjusted in adult patients with type 2 diabetes on basal insulin and OADs using either the Q1D or Q3D algorithm.1

  • Patients began mealtime insulin with one injection at breakfast1
  • Carbohydrate counting and correction factors were not needed to determine dose
  • 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 days.
  • Patients using the Q1D algorithm experienced a mean decrease in A1C from baseline of 1% by the 24th week of therapy*1
  • Using the Q1D patients, almost half achieved an A1C ≤7.0% at endpoint 24 weeks†1
  • With the Q1D algorithm, 61.2% of patients required only 1 or 2 mealtime injections at endpoint1-3
  • In patients aged 65 and older and the overall study population, there was no statistically significant treatment-by-subgroup difference in A1C from baseline to endpoint‡1

All efficacy analyses were based upon the full analysis set (patients in the all-randomized population who took at least 1 dose of insulin lispro).

*Change in A1C in the 24-week AUTONOMY study of Q1D and Q3D algorithms of Study A (N=528) and Study B (N=578). Data were reported as least square mean (LSM) ± standard error (SE) of the mean and 95% CI from a mixed effect model for repeated measures (MMRM) that included baseline A1C, strata, treatment algorithm, visit, and treatment algorithm by visit. Similar results were seen with the Q3D arm of the study.

The percentages of patients achieving A1C targets at the end of the study (last observation carried forward [LOCF]) were analyzed using a logistic regression model with terms for treatment algorithm and strata.

Data are reported as mean (SE) at week 24. N=number of patients in specified treatment and subgroup category. Results are based on patients with non-missing A1C at baseline and at week 24 in the specified treatment and subgroup category. P-values for the 2-way interaction (treatment by subgroup) are from the MMRM model: response=baseline + strata + treatment + visit + treatment by visit + subgroup + treatment by subgroup.

Select Safety Information

  • Humalog should be given within 15 minutes before or immediately after a meal.

In the AUTONOMY study, patients initiated therapy with one injection at breakfast1

  • Injections using the AUTONOMY algorithm were administered using Humalog® U-100 KwikPen1,2
  • Carbohydrate counting was not required to adjust titration1
  • Under healthcare provider direction, patients recorded their BG readings, and then self-adjusted their prandial insulin based on their readings1

Starting dose1

  • The initial breakfast mealtime dose was equivalent to 10% of the total daily glargine dose

Patients assessed and adjusted their own mealtime insulin1

  • 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
Yesterday’s prelunch blood glucose reading Today’s breakfast dose

Q1D dosing information

Additional doses were added at the healthcare provider’s discretion1,4

  • 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 Weeks1,3:

Percentages of patients in AUTONOMY study requiring 1, 2, or 3 injections per day

  • 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 endpoint1-3

Yesterday’s pre-dinner blood glucose reading Today’s lunch dose

Yesterday’s bedtime blood glucose reading Today’s dinner dose

The Lilly Answers Center

Ask your Lilly Diabetes Sales Representative or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) about the My Mealtime Tracker to assist patients in using the self-titration algorithm.

Efficacy with Q1D self-titration algorithm

Patients experienced a 1.0% mean reduction in A1C from baseline to endpoint with the Q1D self-titration algorithm1

1% Mean A1C Reduction (primary endpoint)

*For Q3D, the reduction of A1C from baseline at week 24 was -0.96% for Study A and -0.92% for Study B.

All efficacy analyses were based upon the full analysis set (subjects in the all-randomized population who took at least one dose of insulin lispro). A limitation of this study was the exclusion of subjects with BMIs ≥45 kg/m2.

Change in A1C in the 24-week AUTONOMY study of Q1D and Q3D algorithms, of Study A (N=528) and Study B (N=578). Data were reported as least square mean (LSM) ± SE of the mean and 95% CI from a mixed effect model for repeated measures (MMRM) that included baseline A1C, strata, treatment algorithm, visit, and treatment algorithm by visit.

Similar results were seen with the Q3D arm of the study.

Using the Q1D algorithm, almost half of the patients achieved an A1C of ≤7.0% at 24 weeks1

Patients Who Achieved A1C ≤7.0% at 24 Weeks1,5,6

Patients who achieved A1C ≤7.0% at 24 weeks

Q1D and Q3D algorithms in both studies resulted in similar percentages of patients achieving A1C ≤7%.1

*12 patients had an A1C ≤7% at baseline in Study A and 16 patients in Study B.

All efficacy analyses were based upon the full analysis set (patients in the all-randomized population who took at least 1 dose of insulin lispro). The percentages of patients achieving A1C targets at the end of the study (LOCF) were analyzed using a logistic regression model with terms for treatment algorithm and strata.

Patients ≥65 Years of Age Who Achieved A1C ≤7.0% at 24 Weeks1,5,6

Patients ≥65 years of age who achieved A1C ≤7.0% at
24 weeks

Q1D and Q3D algorithms in both studies resulted in similar percentages of patients ≥65 years of age achieving A1C ≤7%.1

*5 patients over 65 years of age had an A1C ≤7% at baseline in Study A and 4 in Study B.

All efficacy analyses were based upon the full analysis set (patients in the all-randomized population who took at least 1 dose of insulin lispro). The percentages of patients achieving A1C targets at the end of the study (LOCF) were analyzed using a logistic regression model with terms for treatment algorithm and strata.

Data are reported as mean (SE) at week 24. N= number of patients in specified treatment and subgroup category. Values are based on patients with non-missing A1C at baseline and at week 24 in the specified treatment and subgroup category. P-values for the 2-way interaction (treatment by subgroup) are from the MMRM model: response=baseline + strata + treatment + visit + treatment by visit + subgroup + treatment by subgroup. The primary and secondary objectives were evaluated for the overall population and subjects ≥65 years old.

Hypoglycemia and weight gain in the AUTONOMY study

Overall Hypoglycemia Rates and Incidence in the AUTONOMY Study7

Type of Hypoglycemia
(rate and incidence)
Study A:
Q1D (n=268)
Study B:
Q1D (n=289)
Total hypoglycemia
incidence (n [%])
231 (86.2) 238 (82.4)
Total hypoglycemia
rate per 30 days
3.15 ± 0.23 3.18 ± 0.26
Symptomatic hypoglycemia
incidence (n [%])
194 (72.4) 205 (70.9)
Symptomatic hypoglycemia
rate per 30 days
1.72 ± 0.16 1.50 ± 0.15
Nocturnal hypoglycemia
incidence (n [%])
169 (63.1) 156 (54.0)
Nocturnal hypoglycemia
rate per 30 days
0.71 ± 0.07 0.59 ± 0.07
Severe hypoglycemia
incidence (n [%])
5 (1.9) 7 (2.4)
Severe hypoglycemia
rate per 30 days
0.00 ± 0.03 0.01 ± 0.09

Data are n (%), negative binomial mean (NBM) ± SE. Incidence is reported as the number of patients with at least 1 hypoglycemic episode. All safety outcomes were assessed in the all-randomized population (all patients who entered the study, completed the glargine optimization lead-in period [if applicable], and were randomized to 1 of the 2 treatment arms). The rate of total, nocturnal, and severe hypoglycemia per year during the treatment phase was analyzed using LOCF.

Similar rates and incidence of hypoglycemia were observed in Q1D and Q3D algorithms in both studies (A and B).

A hypoglycemic episode was defined as any time a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia, or had a blood glucose level of ≤70 mg/dL even if it was not associated with signs, symptoms, or treatment.

Documented symptomatic hypoglycemia was defined as an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration ≤70 mg/dL.

A nocturnal hypoglycemic episode was defined as any time a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia, or had a blood glucose level of ≤70 mg/dL even if it was not associated with signs or symptoms and occurred after bedtime and prior to the first meal upon waking (eg, breakfast).

A severe hypoglycemic episode was defined as any time a patient required assistance of another person for treatment and that was accompanied by neurologic (cognitive) impairment.

Hypoglycemia Rates and Incidence in Patients
Aged 65 Years and Older in the AUTONOMY Study7

Type of Hypoglycemia
(rate and incidence)
Study A:
Q1D (n=66)
Study B:
Q1D (n=56)
Total hypoglycemia
incidence (n [%])
60 (90.9) 51 (91.1)
Total hypoglycemia
rate per 30 days
3.42 ± 0.45 4.22 ± 0.68
Symptomatic hypoglycemia
incidence (n [%])
52 (78.8) 39 (69.6)
Symptomatic hypoglycemia
rate per 30 days
1.71 ± 0.29 1.85 ± 0.42
Nocturnal hypoglycemia
incidence (n [%])
45 (68.2) 42 (75.0)
Nocturnal hypoglycemia
rate per 30 days
0.72 ± 0.12 0.99 ± 0.20
Severe hypoglycemia
incidence (n [%])
3 (4.5) 1 (1.8)
Severe hypoglycemia
rate per 30 days
0.01 ± 0.04 0.00 ± 0.03

Data are n (%), NBM ± SE.

Incidence is reported as the number of patients with at least one hypoglycemic episode. All safety outcomes were assessed in the all-randomized population (all patients who entered the study, completed the glargine optimization lead-in period [if applicable], and were randomized to 1 of the 2 treatment arms). The rate of total, nocturnal, and severe hypoglycemia per year during the treatment phase was analyzed using LOCF.

Similar rates and incidence of hypoglycemia were observed in Q1D and Q3D algorithms in both studies (A and B) in patients ≥65 years of age.

Weight (kg) Change From Baseline (LSM ± SE) at 24 Weeks1

Weight (kg) change from baseline (LSM ± SE) at 24 weeks
  • Patients following the AUTONOMY Q1D algorithm had mean weight gains of approximately 2.15 to 2.47 kg (4.7 to 5.4 lb) in Study A and Study B, respectively, during the study period1,8
  • In Study A, Q3D participants gained slightly more weight (approximately 1.8 lb) than Q1D participants1

Data were reported as LSM ± SE of the mean based upon an MMRM that included baseline weight, strata, treatment algorithm, visit, and treatment algorithm by visit.

References

  1. 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.
  2. Data on file, Lilly Research Laboratories: HI20140219B.
  3. Data on file, Lilly Research Laboratories: HI20140225A.
  4. Data on file, Lilly Research Laboratories: HI20140206A.
  5. Data on file, Lilly Research Laboratories: HI20140219C.
  6. Data on file, Lilly Research Laboratories: HI20140219D.
  7. Data on file, Lilly Research Laboratories: HI20150209B.
  8. Data on file, Lilly Research Laboratories: HI20140212A.

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