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

Paris (ots/PRNewswire) -

Sanofi 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? 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 and in New York
.

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

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ots Originaltext: sanofi-aventis Group
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Contact:
Contacts: Global Diabetes Division Communications, Yanyan Chang,Tel:
+49-173-689-6295, E-Mail: yanyan.chang@sanofi.com