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Lantus®/Apidra® SoloSTAR® Help to Improve Patient Satisfaction

June 27, 2011

PARIS, June 27, 2011 /PRNewswire/ –

Sanofi (EURONEXT: SAN and NYSE: SNY) announced today, at the 71st
Scientific American Diabetes Association Sessions 2011, the results of three
studies showing that people with diabetes using Sanofi insulins Lantus(R)
and/or Apidra(R) with the insulin delivery device SoloSTAR(R) experienced
greater treatment satisfaction, better quality of life and lower fear of
hypoglycemia vs those using a premixed insulin product.

The goal of the first study[1], involving 586 patients with uncontrolled
type 2 diabetes on oral agents, was to evaluate any changes in physical and
psychological well-being, diabetes-related symptoms, and patient
satisfaction with diabetes-related care and treatment over the study period
and from baseline to endpoint.

It showed that, compared with those on twice-daily premixed 70/30
insulin aspart (premix), patients on the combination of Lantus(R)- and
Apidra(R)-based regimens experienced better quality of life as measured by
the Diabetes Quality of Life (DQoL) questionnaire, which evaluates personal
perception of improvements as a result of treatment:

        - DQoL improved significantly for all groups at all wks;
          average improvement was greater for basal Lantus(R) (insulin glargine) +
          1 prandial Apidra(R) (insulin glulisine) dose (GLARG+1) and stepwise
          addition of prandial glulisine (GLARG+0-3) vs premix (P=0.0002)
        - Compared to the glargine group, patients on premix also showed
          significantly greater hypoglycemic fear from week 12 to study end
          (P<0.05).

The goal of the second study[2], conducted with 220 type 1 and type 2
patients from 32 sites in Canada, was to evaluate the change in diabetes
treatment satisfaction in people treated with insulin glargine. It showed
that 96% of patients experienced significant treatment satisfaction upon
switching to Lantus(R) SoloSTAR(R) from their previous treatment: Diabetes
Treatment Satisfaction Questionnaire at 6 months = 12.0 (SD = 5.4), compared
to overall satisfaction at baseline.

The objective of the third study, LANSOLEAP[3], involving 143 adults
with either type 1 or type 2 diabetes in Mexico, was to evaluate
satisfaction with the SoloSTAR(R) insulin pen by adult patients. It showed
that:

        - 83% rated SoloSTAR(R) as excellent
        - 78% found SoloSTAR(R) easier to use overall, compared with their
          previous device
        - 87% preferred SoloSTAR(R) to their previous device
        - Of those who had never used a pen device, 83% felt confident
          about using SoloSTAR(R) on the same day they received the pen.

Patient satisfaction is key to improving compliance, and therefore
treatment outcomes. As a patient-centric company focused on the needs of
people with diabetes Sanofi is committed to improving treatment satisfaction
and quality of life.

Notes to editors

About the studies

Polonsky et al (referred as the first study) was a 60-week randomized,
open-label study compared adding BID premixed 70/30 insulin aspart (PREMIX),
basal insulin glargine + 1 prandial insulin glulisine dose (GLARG+1), or
stepwise addition of prandial glulisine (GLARG+0-3) in 586 patients with
uncontrolled type 2 diabetes on oral agents. The objective was to evaluate
any within- and between-group changes in 1) physical and psychological
well-being, 2) diabetes-related symptoms, and 3) patient satisfaction with
diabetes-related care and treatment over the study period and from baseline
to endpoint. While achieving similar glycemic control and body weight
changes, GLARG+1 and GLARG+0-3 were more effective than PREMIX in FBG
reduction and reaching A1C <7%, while causing less overall hypoglycemia.
Patient reported outcomes were measured at baseline, 6, 12, 24, 36, 48, and
60 weeks to assess overall quality of life, diabetes-specific quality of
life (DQoL), hypoglycemic fear and adjustment to illness.

Garon et al (referred as the second study) evaluated the change in
diabetes treatment satisfaction in 220 patients with type 1 or type 2
diabetes treated with Lantus(R) SoloSTAR(R). This 6-month Canadian,
observational, multicenter, prospective registry collected data in 220 T1&T2
Diabetes patients from 32 sites treated with any combination of unmixed
basal insulin, oral anti-hyperglycemic drugs or short-acting insulins who
had HbA1c > 7% or HbA1c = 7% with severe or frequent symptomatic
hypoglycemia were enrolled in the study. Treatment satisfaction was measured
by using the standard Diabetes Treatment Satisfaction Questionnaire at
baseline (DTSQs) and after 6 months (DTSQc). Patients acceptance of
SoloSTAR(R) pen was assessed using 8-item pen use questionnaire having
scores from 1=excellent to 5=very poor. 56 T1DM and 164 T2DM pts were on
average 39.7 (SD=12.4) and 59.3 (SD=11.0) years old and had BMIs of 26.9
(SD=4.7) and 33.4 (SD=8.0) kg/m2, respectively.

LANSOLEAP (referred as the third study) was a multicenter, prospective,
one-arm, six to eight week observational study, involving adults with either
type 1 or type 2 diabetes (who were either insulin users, or insulin naive
and taking oral medications and candidates for insulin therapy). The primary
objective was to evaluate satisfaction with SoloSTAR(R), evaluated by a
self-assessment questionnaire pertaining to overall acceptance (rating of
SoloSTAR(R)) and ease and continuation of use. In a second questionnaire,
insulin users assessed their preference for SoloSTAR(R) compared with their
previous device.

A total of 206 patients were enrolled, with 56 excluded for failing to
meet the minimum time of 30 days between visits. The mean age of the 150
patients whose data could be analyzed was 53.3 years (range 18-90 yrs);
58.7% were female, 86.6% had type 2 diabetes, 68% had a BMI >25, and 70% had
used insulin previously. The 7 patients who did not inject insulin
themselves were excluded from the satisfaction evaluation.

About Lantus[(R)]

Lantus(R) (insulin glargine) is the first 24-hour once-daily basal
insulin analog. Lantus(R) is as effective as NPH insulin with similar
reductions in HbA1c, but is associated with lower fasting blood glucose
concentrations. People with Type 2 diabetes experience a consistent and
significant reduction in the incidence of nocturnal hypoglycemia with
Lantus(R).[4]

About Apidra[(R)]

Apidra(R) is a fast-acting insulin analog of human insulin with a
zinc-free molecular structure that maintains a rapid onset and a short
duration of action, indicated for the treatment of adults with type 1 and
type 2 diabetes. Apidra(R) offers mealtime dosing flexibility – it can be
taken 15 minutes before or within 20 minutes after starting a meal, and in a
variety of body types, from lean to obese.

About SoloSTAR(R)

SoloSTAR(R) is Sanofi’s prefilled, multi-purpose, disposable insulin pen
for the administration of Lantus(R), Apidra(R) and Insuman(R).
SoloSTAR[(R)]is the winner of a GOOD DESIGN(TM) Award.

About the Sanofi Diabetes Division

Sanofi strives to help people manage the complex challenges of diabetes
by delivering innovative, integrated and personalized solutions. Driven by
valuable insight that comes from listening to and engaging with people
living with diabetes, the Company is forming partnerships to offer
diagnostics, therapies, services, and devices. Sanofi markets both
injectable and oral medications for people with type 1 or type 2 diabetes.
Investigational compounds in the pipeline include an injectable GLP-1
agonist being studied as a single agent, in combination with basal insulins,
and/or in combination with oral antidiabetic agents.

About Sanofi

Sanofi, a global and diversified 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, rare diseases,
consumer healthcare, emerging markets and animal health. Sanofi is listed in
Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

References

1. Polonksy et al. Patient Reported Outcomes Using Twice-Daily Insulin
Aspart Premixed vs Insulin Glargine Plus 1 Prandial Insulin Glulisine or
Stepwise Addition of Glulisine to Glargine in Type 2 Diabetes Uncontrolled
With Oral Agents (2316-PO) ADA 2011

2. Garon et al. SignificantImprovement in Treatment Satisfaction for
Patients (pts) With Type 1 and Type 2 Diabetes Mellitus (T1&T2DM) After 6
Months Following the Initiation of Insulin Glargine (Lantus SoloSTAR(R))(
2223-PO) ADA 2011

3. Arellano SM, Campuzano RR, Santoyo JC, Mauricio GL. Patient
Satisfaction with the SoloSTAR(R) Insulin Pen Device in Medical Practice in
Mexico: The LANSOLEAP Study (2218-PO) ADA 2011

4. Wang F [http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wang%20F%22%5BAuthor%5D ]
et al. Insulin glargine: a systematic review of a long-acting insulin
analogue. Clin Ther 2003 25:1541-77

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, events, operations,
services, product development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by the
words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”
and similar expressions. Although Sanofi’s management believes that the
expectations reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are difficult to
predict and generally 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 labeling and other matters that could
affect the availability or commercial potential of such products candidates,
the absence of guarantee that the products 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 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, 2010. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking information
or statements.

SOURCE Sanofi


Source: newswire



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