- EDITION I demonstrated similar blood sugar control with fewer
night-time low blood sugar events compared to Lantus® -
- Topline results of EDITION II consistent with EDITION I findings -
PARIS, June 22, 2013 /CNW/ - Sanofi (EURONEXT: SAN and NYSE: SNY)
announced today that the first phase 3 study results (EDITION I) for
its investigational new insulin U300 showed equivalent blood sugar
control with fewer night-time low blood sugar events compared to Lantus® (insulin glargine [rDNA origin] injection). The company also announced
topline results of a second Phase 3 study (EDITION II) for
investigational new insulin U300 that also demonstrated similar blood
sugar reduction while fewer patients experienced night-time low blood
sugar events compared with Lantus®.
These results are from EDITION I and EDITION II respectively and are
part of the EDITION Phase 3 clinical program evaluating the efficacy
and safety of the investigational new insulin U300 in people with
diabetes. The EDITION I data was presented at the 73rd Scientific
Sessions of the American Diabetes Association.
"To properly manage diabetes, it is critical to control blood sugar and
to reduce the risk of low blood sugar events, especially at night," said Matthew Riddle, Professor of Medicine, Division of
Endocrinology/Diabetes/Clinical Nutrition, Oregon Health and Science
University, U.S., and Principal Investigator for the EDITION I study. "I am encouraged by these findings, and look forward to the results of
the full Phase 3 EDITION program, which will further reveal how this
investigational basal insulin may help people living with diabetes."
As the first study of the EDITION Phase 3 program, EDITION I evaluated
the efficacy and safety of investigational new insulin U300, vs. Lantus® in people with type 2 diabetes using basal plus mealtime insulin. In a
multicenter, open-label study 807 people were randomized (1:1) to once
daily evening new insulin U300 (n=404) or Lantus® (n=403) while continuing mealtime insulin. The basal insulin was
titrated to achieve fasting plasma glucose of 80-100 mg/dL. Primary
endpoint was change in HbA1c from baseline to month 6, and main secondary endpoint was % of people
with at least 1 severe or confirmed (≤70 mg/dL) nocturnal hypoglycemic
event from month 3 to month 6.
EDITION I demonstrated similar reductions in HbA1c (glycated hemoglobin) from baseline (primary endpoint) between new
insulin U300 and Lantus® at 6 months [least squares mean change -0.83% (0.06) in both groups;
difference -0.00% (95% CI -0.11 to 0.11)] in people with type 2
diabetes who had challenging treatment needs (mean age of study
participants: 60 years; duration of type 2 diabetes: 15.8 years; BMI:
36.6 kg/m2; HbA1c: 8.15 %; total insulin dose: 1.2 U/kg; basal insulin dose: 0.67 U/kg at
baseline). In addition, approximately 40% of study participants with
uncontrolled glycemic (blood sugar) levels despite receiving a combined
therapy (oral antidiabetic agents plus basal and prandial insulins)
reached glycemic control (HbA1c <7%) at month 6 both in the new insulin U300 (39.6%) and in the Lantus® arm (40.9%).
The investigational new insulin U300 was associated with a 21% reduction
in severe or confirmed nocturnal hypoglycemia (low blood sugar) from
month 3 to month 6. Significantly fewer patients had nocturnal (severe
and/or confirmed; i.e. ≤70 mg/mL) hypoglycemia (low blood sugar) during
months 3 to 6 (pre-specified main secondary endpoint: 36.1% vs. 46.0%;
RR 0.79; p=0.0045) and the occurrence of any nocturnal hypoglycemic
event (% of people with at least one event) during the 6-month study
period was lower on new insulin U300 during the study period compared
to the Lantus® group (45.3% vs. 59.7%; RR 0.76; 95% CI 0.66 to 0.87). New insulin U300
was well-tolerated in this study, with no differences in other adverse
events observed from Lantus®.
The EDITION I abstract is titled: New Insulin Glargine Formulation: Glucose Control and Hypoglycemia in
People with Type 2 Diabetes Using Basal and Mealtime Insulin (EDITION
I) (Riddle, MC et al) [Abstract no. 43-LB]
Topline results of EDITION II are consistent with EDITION I findings.
EDITION II demonstrated that investigational new insulin U300 achieved
similar blood sugar reduction while fewer patients experienced
night-time low blood sugar events compared with Lantus®.
EDITION II evaluated efficacy and safety of new insulin U300 in a type 2
diabetes population (811 patients) treated with basal insulin plus oral
antidiabetic therapy. The full EDITION II results will be submitted for
presentation at upcoming scientific meetings.
"There remains a substantial unmet need in people with diabetes taking
oral medication or insulin as many of them do not reach their glycemic
goals," said Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "With the investigational new insulin U300, we are striving to further
enhance the clinical value of basal insulin, while building on the
wealth of evidence of Lantus®, the world's most prescribed insulin."
About investigational new insulin U300
Investigational new insulin U300 is a new formulation based on the
glargine molecule, the biological entity of Lantus®, with its well established efficacy and safety profile. However, new
insulin U300 has unique pharmacokinetic and pharmacodynamic profiles
with studies demonstrating it has even flatter and more prolonged
profiles than Lantus®., New insulin U300 also offers the benefit of a smaller volume of
subcutaneous injection compared with Lantus®.
About the EDITION Phase 3 Program
The EDITION program is a worldwide and comprehensive series of Phase 3
studies evaluating the efficacy and safety of new insulin U300 in
broader and diverse populations of people with diabetes. The full
EDITION I (basal + mealtime insulin) and EDITION II (basal Insulin +
oral therapy) results are expected by the end of this year.
Additionally, the following Phase 3 studies from the EDITION program
are ongoing: EDITION III in insulin-naïve type 2 diabetes patients ,
EDITION IV in type 1 diabetes patients, EDITION JP I in Japanese type 1
diabetes patients (basal + bolus insulin) and EDITION JP II in Japanese
type 2 diabetes patients (basal insulin + oral therapy).
Diabetes is a chronic disease that occurs as type 1 diabetes, which is
an autoimmune disease characterized by the lack of insulin (the hormone
that regulates blood glucose concentrations) production by the
pancreas, and type 2, a metabolic disorder in which there are two main
biological defects: a deficient production of insulin and reduced
ability of the body to respond to the insulin being produced. Type 1
and type 2 diabetes are characterized by an increase in blood glucose
concentrations (hyperglycemia). Over time, uncontrolled hyperglycemia
leads to the macrovascular and microvascular complications of diabetes.
Macrovascular complications, which affect the large blood vessels,
include heart attack, stroke and peripheral vascular disease.
Microvascular complications affect the small blood vessels of the eyes
(retinopathy), kidney (nephropathy) and nerve (neuropathy). The global
incidence of diabetes is growing at an alarming rate, with more than
371 million people worldwide living with the condition today.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes
by delivering innovative, integrated and personalized solutions. Driven
by valuable insights that come from listening to and engaging with
people living with diabetes, the Company is forming partnerships to
offer diagnostics, therapies, services and devices, including blood
glucose monitoring systems. Sanofi markets both injectable and oral
medications for people with type 1 or type 2 diabetes.
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi
has core strengths in the field of healthcare with seven growth
platforms: diabetes solutions, human vaccines, innovative drugs,
consumer healthcare, emerging markets, animal health and the new
Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York
Tillner J et al. Euglycemic Clamp Profile of New Insulin Glargine U300
Formulation in Patients With Type 1 Diabetes (T1DM) is Different >From
Glargine U100.73rdScientific Sessions of the ADA, abstract no. 920-P
Dahmen R et al New Insulin Glargine U300 Formulation Evens and Prolongs
Steady State PK and PD Profiles During Euglycemic Clamp in Patients
With Type 1 Diabetes (T1DM)". 73rd Scientific Sessions of the ADA, abstract no. 113-OR
Forward Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial results,
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Sanofi's management believes that the expectations reflected in such
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forward-looking information and statements are subject to various risks
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beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied
or projected by, the forward-looking information and statements. These
risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory
authorities, such as the FDA or the EMA, regarding whether and when to
approve any drug, device or biological application that may be filed
for any such product candidates as well as their decisions regarding
labelling and other matters that could affect the availability or
commercial potential of such product candidates, the absence of
guarantee that the product candidates if approved will be commercially
successful, the future approval and commercial success of therapeutic
alternatives, the Group's ability to benefit from external growth
opportunities, trends in exchange rates and prevailing interest rates,
the impact of cost containment policies and subsequent changes thereto,
the average number of shares outstanding as well as those discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under "Risk Factors" and "Cautionary
Statement Regarding Forward-Looking Statements" in Sanofi's annual
report on Form 20-F for the year ended December 31, 2012. Other than as
required by applicable law, Sanofi does not undertake any obligation to
update or revise any forward-looking information or statements.
Sanofi will host a conference call for the financial community on Monday
June 24, 2013, at 700 AM CST (200 PM Paris Time). The call will include
results from the ongoing EDITION phase 3 program for U300 as well as a
status update on the fixed-ratio combination of insulin glargine and
Dial-in numbers and the audio webcast link will be accessible via http://www.sanofi.com.
SOURCE: Sanofi Diabetes
For further information:
Contacts: Corporate Media Relations, Marisol Peron, Tel.: +33 1 53 77 45 02, Mobile: +33 6 08 18 94 78, E-mail: email@example.com ; Global Diabetes Communications, Tilmann Kiessling, Mobile: +49 17 26 15 92 91, E-mail: Tilmann.Kiessling@sanofi.com ; Investor Relations, Sébastien Martel , Tel.: +33(0)1 53 77 45 45, E-mail: IR@sanofi.com ; US Diabetes Communciations, Susan Brooks, Tel : +1(0)908 981 65 66, Mobile: +1(0)201 572 49 94, E-mail: Susan.Brooks@sanofi.com