Sanofi Announces Positive Phase 3 Results for Investigational New Insulin U300
Sanofi Announces Positive Phase 3 Results for Investigational New Insulin U300
AsiaNet 53484
PARIS, June 23, 2013/PRN=KYODO JBN/ --
- EDITION I demonstrated similar blood sugar control with fewer night-time
low blood sugar events compared to Lantus(R)-
- Topline results of EDITION II consistent with EDITION I findings -
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(R) (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(R).
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."
EDITION I
As the first study of the EDITION Phase 3 program, EDITION I evaluated the
efficacy and safety of investigational new insulin U300, vs. Lantus(R) 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(R) (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
(less than or equal to70 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(R) 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(R) 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. less than or equal to70 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(R) 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(R).
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]
EDITION II
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(R).
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(R), 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(R), 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(R).[1],[ 2] New insulin
U300 also offers the benefit of a smaller volume of subcutaneous injection
compared with Lantus(R).
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-naive 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).
About Diabetes
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.
About Sanofi
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 (NYSE: SNY).
References
1) 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. 73rd Scientific Sessions of the ADA, abstract no. 920-P
2) 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
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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 lixisenatide.
Dial-in numbers and the audio webcast link will be accessible via
SOURCE: Sanofi Diabetes
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