Two Studies Show Insulin Glargine Control of HbA(1C) in Poorly Controlled
Type 2 Diabetes Patients, with Comparable Rates of Hypoglycemia
BRIDGEWATER, N.J., June 13 /PRNewswire-FirstCall/ -- Data presented today
at the 65th Session of the American Diabetes Association (ADA), San Diego,
demonstrated that people with type 2 diabetes achieved significantly better
glycemic control, and also achieved it earlier, when treated with the 24-hour
basal insulin analog Lantus(R) (insulin glargine [rDNA origin] injection,
sanofi-aventis) and their usual oral antidiabetes therapies* compared with
patients receiving oral therapy alone, with comparable rates of hypoglycemia.
Further data at the ADA show that Lantus(R) can be safely and effectively
initiated in both primary and secondary care, to achieve their target glycemic
control.
"These studies re-affirm that Lantus can help more people with type 2
diabetes reach their target blood sugar levels, and reach them earlier, so
that introducing insulin glargine earlier in these patients may be beneficial.
This data also highlights that Lantus can be titrated confidently and safely
in both a primary and secondary care settings with comparable rates of
hypoglycemia," commented Hertzel Gerstein and one of the investigators in the
INSIGHT study.
The INSIGHT (Implementing New Strategies with Insulin Glargine for
Hyperglycemia Therapy) study of 405 patients with type 2 diabetes for at least
6 months, demonstrated that earlier addition of insulin glargine to current
diabetes therapy effectively reduced HbA(1C) levels significantly more than
optimization of oral agents, and with comparable rates of hypoglycemia.
During the study, patients received either addition of once daily insulin
glargine (with no increase in oral antidiabetic therapy [OAD]), or were
optimized on OAD therapy with no insulin.
There were no differences in hypoglycemia noted between those receiving
Lantus and those receiving oral agents.
The American Diabetes Association recommends that people with diabetes
achieve an HbA(1C) <7% for optimal diabetes control, although more stringent
glycemic goals (i.e. a normal HbA(1C), <6%) may further reduce complications
at the cost of increased risk of hypoglycemia. Other organizations, namely the
European Diabetes Policy Group (EDPG) and the American Association of Clinical
Endocrinologists (AACE), recommend a lower target of under 6.5%.
In clinical practice, however, the majority of patients with type 2
diabetes do not routinely reach treatment targets. According to the National
Health and Nutrition Examination Survey (NHANES IV) 1999-2000, only 37% of
participants with previously diagnosed diabetes achieved the target HbA(1C)
goal of less than 7.0%, and 37.2% of participants were above the "take action"
HbA(1C) level of greater than 8.0%. These figures did not change significantly
from those reported in NHANES III, which encompassed the years 1988 to 1994.
Another study, presented at the ADA, focusing on a sub-analysis of the
AT.LANTUS trial in UK patients, further confirmed that Lantus(R) can be safely
and effectively initiated in both primary and secondary care. The data
highlighted that severe and nocturnal hypoglycemia rates are comparable
between primary and secondary care managed patients (p=NS).
The UK sub-analysis data are part of one of the largest prospective
treatment trials of diabetes management ever undertaken -- AT.LANTUS, (A Trial
comparing Lantus(R) Algorithms to achieve Normal blood glucose Targets in
patients with Uncontrolled blood Sugar) -- published in the June 2005 issue of
the ADA's Diabetes Care journal. The global study of nearly 5,000 people from
59 countries with type 2 diabetes, demonstrated that a simple patient-
administered titration algorithm with Lantus(R) significantly improves
glycemic control with a low risk of severe hypoglycemia.
"We know from large, landmark studies that a reduction on HbA(1C) levels
reduces the risk of a diabetic patient from developing both the micro and
macrovascular complications of diabetes. With over half of the patients with
type 2 diabetes failing to reach their glycemic targets, the inclusion of
Lantus the first and only once-daily, insulin analog which may be used in
combination with oral antidiabetes agents, provides an important approach to
achieving better glycemic control," commented Dr. Melanie Davies, Consultant
in Diabetes at the University Hospitals of Leicester.
* 83.2% of patients received their usual OAD whereas 16.8% were treated
only with lifestyle intervention
About LANTUS(R) (insulin glargine [rDNA origin] injection)
Lantus(R) is indicated for once-daily subcutaneous administration, at the
same time each day, for the treatment of adult and pediatric patients (6 years
and older) with type 1 diabetes mellitus or adult patients with type 2
diabetes mellitus who require basal (long-acting) insulin for the control of
hyperglycemia.
LANTUS(R) MUST NOT BE DILUTED OR MIXED WITH ANY OTHER INSULIN OR SOLUTION.
If mixed or diluted, the solution may become cloudy, and the onset of
action/time to peak effect may be altered in an unpredictable manner.
Lantus(R) is contraindicated in patients hypersensitive to insulin
glargine or the excipients.
Hypoglycemia is the most common adverse effect of insulin, including
Lantus(R). As with all insulins, the timing of hypoglycemia may differ among
various insulin formulations. Glucose monitoring is recommended for all
patients with diabetes. Any change of insulin type and/or regimen should be
made cautiously and only under medical supervision. Concomitant oral
antidiabetes treatment may need to be adjusted.
Other adverse events commonly associated with Lantus(R) include the
following: lipodystrophy, skin reactions (such as injection-site reaction,
pruritus, rash) and allergic reactions.
For full prescribing information, please visit http://www.lantus.com.
About sanofi-aventis
The sanofi-aventis Group is the world's third largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven major
therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases,
central nervous system, internal medicine, and vaccines. The sanofi-aventis
Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)
The sanofi-aventis Group conducts its business in the United States
through its subsidiaries Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc.
and Sanofi Pasteur Inc.
U.S. Contacts: Terri Pedone, +1-908-243-6578,
Terri.Pedone@sanofi-aventis.com
SOURCE sanofi-aventisWeb Site: http://www.sanofi-aventis.com http://www.lantus.comCompany News On Call: Company News On-Call: http://www.prnewswire.com/comp/232375.html
