Impact of Early Insulin Initiation on Glycemic Control in Asian People with Type 2 Diabetes
Geschrieben am 05-12-2011 |
Paris (ots/PRNewswire) -
Two studies presented at World Diabetes Congress 2011 provide further
evidence of the benefits to patients of early glycemic control on co-morbidities
Sanofi announced today new results from sub-analyses of the
First Basal INsulin Evaluation in Asia (FINE Asia) Registry study,[1]
and the Cardiovascular Risk Evaluation in People with Type 2 Diabetes
on Insulin Therapy (CREDIT) study.[2]
FINE Asia was a six-month, 11-Asian-country prospective
observational study to assess the effect of 'time to basal insulin
initiation' on glycemic control and co-morbidities in insulin-naïve
adults with type 2 diabetes (T2D), uncontrolled on oral antidiabetic
medications. Patients (n=2,673) were grouped according to duration of
diabetes since diagnosis (<6y; 6-11y; or greater than or equal
to12y). Results showed that people with T2D who are initiated on
insulin therapy earlier in the progression of their diabetes achieved
greater glycemic control.
Across the FINE Asia sub-analysis groups, baseline HbA1c was
similar (9.8%), and the patients who had the shortest time to insulin
initiation (71-79% insulin glargine users) showed the greatest (mean)
improvement in HbA1c at 6 months: <6y: 7.5%; 6-11y: 7.8%; greater
than or equal to12y: 7.9% (p<0.001 for all three groups).
Likewise, the percentage of patients reaching the target goal
(HbA1c<7%) was less with increasing disease duration; those who had
diabetes for less than 6 years were significantly more likely to
achieve target HbA1c than those who had the disease for over 12
years: <6y: 53.4%; 6-11y: 39.5%; greater than or equal to12y: 32.8%
(p<0.001 for all three groups). The percentage of patients
experiencing hypoglycemic events was similar across groups.
Patients whose disease duration was relatively shorter
experienced a significantly lower incidence of several
co-morbidities, including retinopathy, neuropathy, nephropathy,
coronary artery disease, hypertension and dyslipidemia. Early
initiation of insulin therapy was associated with a reduction of
diabetes-related complications, as well as other common
co-morbidities. The levels of improvement following six months of
basal insulin therapy varied with the number of years since disease
diagnosis. The FINE Asia sub-analysis was not part of the original
study protocol.
These results are supported by recent findings from a one-year
real-life study of Cardiovascular Risk Evaluation in People with Type
2 Diabetes on Insulin Therapy (CREDIT), an international, multicenter
observational study designed to assess the metabolic and diabetes
parameters of people with T2D on long-term insulin therapy.
Results from a Japanese sub-analysis indicated that early
initiation of insulin resulted in better glycemic control (HbA1c:
10.7% vs 7.9%; fasting plasma glucose [FPG]: 12.1mmol/l vs 7.7mmol/l;
post-prandial glucose [PPG]: 16.5mmol/l vs 9.9mmol/l, p<0.001), with
a low incidence of severe hypoglycemia and improved cardiovascular
(CV) risk parameters at one year. The results from CREDIT are in line
with the FINE Asia sub-analysis in supporting early insulin
initiation in order to improve glycemic control and CV risk profile
in people with type 2 diabetes.
"The results of the FINE Asiasub-analysis, as supported by the
CREDIT 1-year Japanese study,indicate that in Asian people with type
2 diabetes, early treatment with insulin may be associated
withsignificant improvements in glycemic control. Most importantly,
early glycemic control may lead to significant improvement in
cardiovascular risk parameters and reduction inthe incidence of
co-morbidities," said Riccardo Perfetti, Vice President, Medical
Affairs, Sanofi Diabetes.
Both the FINE Asia sub-analysis and the 1-year follow-up of the
CREDIT study are presented today at the International Diabetes
Federation (IDF) World Diabetes Congress, Dubai.
References
1: Variation of Glycemic Control and Patient Comorbidities With
Duration of Type 2 Diabetes in Asian Patients: Analysis of the FINE
Asia Registry. IDF/WDC 2011 Poster P-1455.
2: Baseline and 1-year interim follow-up assessment of Japanese
patients initiating insulin therapy enrolled in the CREDIT study.
IDF/WDC 2011 Poster P-1426.
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.
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 insulin, 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
.
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.
Contacts:
Corporate Media Relations Sanofi Diabetes Global Communications
Marisol Peron Tilmann Kiessling
Tel: +33(0)1-53-77-45-02 Mobile: +49(0)172-61-59-291
Mobile: +33(0)6-08-18-94-78 E-mail: Tilmann.Kiessling@sanofi.com
E-mail: Marisol.Peron@sanofi.com
ots Originaltext: sanofi-aventis Group
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