INDIANAPOLIS, June 23, 2018 /PRNewswire/ -- Eli Lilly and
Company's (NYSE: LLY) ultra rapid lispro (URLi) led to improved and
sustained blood sugar control after meals in people with type 1 and
type 2 diabetes, according to results from three phase 1b studies evaluating URLi compared to
Humalog®. URLi is Lilly's novel mealtime insulin
currently in phase 3 development. These data will be presented in
three poster presentations at the American Diabetes Association
(ADA) 78th Scientific Sessions® in
Orlando.
Two of the studies evaluated URLi administered through multiple
daily injections in people with type 1 and type 2 diabetes to
understand the differences in the pharmacokinetics (the amount of
insulin in the blood) and pharmacodynamics (how insulin works to
control blood glucose levels) between URLi and Humalog. The third
study evaluated URLi delivered through an insulin pump in people
with type 1 diabetes. Across all three studies, URLi was absorbed
faster than Humalog, which led to improved post-meal blood sugar
control that was sustained over time.
Researchers used solid mixed meal tolerance tests (MMTT) to
evaluate URLi in people with type 1 and type 2 diabetes, measuring
post-meal blood sugar response based on injections 15 minutes
before a meal, at the start of the meal, or 15 minutes after the
start of a meal. Results showed that compared to Humalog, URLi
reduced post-meal blood sugar over the first five hours after
eating by 44 percent in people with type 1 diabetes and 105 percent
in people with type 2 diabetes when dosed at mealtime. URLi was
also evaluated in people with type 1 diabetes using insulin pumps.
Results of MMTTs conducted on days 1 and 3 of pump treatment showed
that URLi reduced post-meal blood sugar by 20 to 57 percent over
the five-hour period after eating.
Overall, URLi and Humalog had similar safety and tolerability
profiles across all three studies.
"These data bolster our confidence in ultra rapid lispro as the
next advancement for people who require mealtime insulin," said
Tom Hardy, senior medical director
at Lilly. "Managing diabetes with mealtime insulin can be
difficult, often requiring a strict schedule around what and how
much people eat, as well as when they take their insulin. URLi has
the potential to improve mealtime blood sugar control for people
with type 1 and type 2 diabetes."
URLi is currently in phase 3 studies in people with type 1 and
type 2 diabetes. These trials are expected to complete later this
year.
About the Studies
The pharmacokinetics (PK) and
pharmacodynamics (PD) of ultra rapid lispro (URLi) administered by
multiple daily injections in people with type 1 and type 2 diabetes
were evaluated in two, two-part, randomized, double-blind phase
1b studies. Part A used a 6-period
crossover design to evaluate safety and compare postprandial
glucose response to solid mixed meal tolerance tests (MMTT) with
URLi and Humalog at different injection to mealtime intervals (-15,
0, and +15 minutes). Part B evaluated the safety, PK and PD during
two weeks of multiple daily dosing (immediately before a meal) in a
parallel design.
The PK and PD of URLi administered through a pump in people with
type 1 diabetes were evaluated in a double-blind, randomized
cross-over study. The study evaluated 24 adults with type 1
diabetes over three days by administering MMTTs on days 1 and 3
after pump catheter insertion.
Important Safety Information for Humalog
What is the most important information I should know about
Humalog?
- Do not share your Humalog KwikPen, Humalog Junior 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.
- 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 with any
other insulin or liquid.
Who should not take Humalog?
- 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.
Before using Humalog, 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 is a rapid-acting insulin. Take Humalog within fifteen
minutes before eating or right after eating a meal.
- Always make sure you receive the correct type of Humalog from
the pharmacy.
- Do not use Humalog if it is cloudy, colored, or has solid
particles or clumps in it.
- Inject Humalog 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?
- 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 Humalog. 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 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. 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 or Humalog.
- 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 www.fda.gov/medwatch or call
1-800-FDA-1088.
Humalog is available by prescription only.
For additional information, talk to your healthcare providers
and please click to access Full Prescribing
Information and Patient Prescribing Information.
Please see Instructions for Use included with the Humalog
KwikPen.
HI CON ISI 06JUN2017
About Diabetes
Approximately 30 million
Americans4 and an estimated 425 million adults worldwide
have diabetes.5 Type 2 diabetes is the most common type
internationally, accounting for an estimated 90 to 95 percent of
all diabetes cases in the United
States alone.4 Diabetes is a chronic disease that
occurs when the body does not properly produce or use the hormone
insulin.
About Lilly Diabetes
Lilly has been a global leader in
diabetes care since 1923, when we introduced the world's first
commercial insulin. Today we are building upon this heritage by
working to meet the diverse needs of people with diabetes and those
who care for them. Through research, collaboration and quality
manufacturing we strive to make life better for people affected by
diabetes. We offer a wide range of therapies and a continued
determination to provide real solutions—from medicines and
technologies to support programs and more. For the latest updates,
visit http://www.lillydiabetes.com/ or follow us on Twitter:
@LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
www.lilly.com/newsroom/social-channels.
P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about Ultra Rapid Lispro as a treatment of type 1 and type 2
diabetes, and Lilly's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee that future study
results will be consistent with study findings to date, that Ultra
Rapid Lispro will receive regulatory approvals or that Ultra Rapid
Lispro will prove to be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's
most recent Form 10-K and Form 10-Q filings with the United States
Securities and Exchange Commission. Except as required by law,
Lilly undertakes no duty to update forward-looking statements to
reflect events after the date of this release.
©LillyUSA, LLC 2018. All rights reserved.
Refer to: DeShong
Perry-Smitherman; perry_smitherman_deshong@lilly.com
317-719-4612
References:
|
|
1.
|
Plum- Möerschel L.,
Leohr J., et al. Ultra Rapid Lispro (URLi) Reduces Postprandial
Glucose Excursions vs. Humalog® in Patients with T1D at Multiple
Meal-to-Dose Timing Intervals. Abstract 1010-P. Presented at
78th American Diabetes Association Scientific
Sessions; June 22-26, Orlando, FL.
|
2.
|
Kapitza C., Leohr J.,
et al. Ultra Rapid Lispro (URLi) Reduces Postprandial Glucose
Excursions vs. Humalog® in Patients with T2D at Multiple
Meal-to-Dose Timing Intervals. Abstract 1009-P. Presented at
78th American Diabetes Association Scientific Sessions;
June 22-26, Orlando, FL.
|
3.
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Kazda C., Leohr J.,
et al. Ultra Rapid Lispro (URLi) shows faster absorption of insulin
lispro vs Humalog® during insulin pump (CSII) use in patients with
T1D. Abstract 1006-P. Presented at 78th American
Diabetes Association Scientific Sessions; June 22-26, Orlando,
FL.
|
4.
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Centers for Disease
Control and Prevention. National Diabetes Statistics Report, 2017.
Available at:
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
November 2017.
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International
Diabetes Federation. IDF Diabetes Atlas, 8th edn, 2017. Available
at: http://www.diabetesatlas.org/. November 2017.
|
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