- First Randomized Controlled Trial to Show That Basal Plus Regimen
Provides more Effective Glycemic Control with Less Hypoglycemia Than
with Aspart Premixed Insulin
PARIS, Sept. 12, 2011 /CNW/ - Sanofi (EURONEXT: SAN and NYSE: SNY)
announced today data presented at the 47th Annual Meeting of the
European Association for the Study of Diabetes to show that adding
mealtime Apidra(R) (insulin glulisine) to Lantus(R) (insulin glargine)
is more efficacious, with less hypoglycemia, than introducing aspart
premixed insulin twice daily.
"Comparison of 3 intensified insulin regimens added to oral therapy for
type 2 diabetes: twice-daily aspart premixed vs glargine plus 1
prandial glulisine or stepwise addition of glulisine to glargine"
Results from the All-to-Target trial show that people with type 2
diabetes, whose treatment with oral antidiabetic therapy is
unsuccessful, may advance to intensified insulin treatment. Adding
mealtime Apidra(R) insulin to a Lantus(R) basal-insulin regimen is an
effective treatment strategy for insulin intensification, sustaining
continuity of care throughout the duration of the disease.
The stepwise addition of Apidra(R) prandial (mealtime) doses to
Lantus(R) treatment can also be an effective introduction to a full
All-to-Target is a 60-week, randomized, open-label study comparing
efficacy, hypoglycemia rates and body weight in people with type 2
diabetes treated with three different insulin regimens: premixed 70/30
protamine-aspart/aspart twice daily (n = 192); Lantus(R) plus one
prandial dose of Apidra(R) (n = 189); and Lantus(R) plus stepwise
addition of Apidra(R) (n = 191).
Significantly more people reached target HbA1c<7% with one mealtime dose
of Apidra(R) plus Lantus (49%, p<0.025), or stepwise addition of
Apidra(R) at mealtimes (45%, p<0.05), than those on premixed insulin
(39%). Furthermore, significantly more people on one mealtime dose of
Apidra(R) plus Lantus(R) (24%, p<0.05) or stepwise addition of
Apidra(R) at mealtimes (24%, p<0.05) achieved target HbA1c with no
hypoglycemia vs. those on aspart premixed insulin (14%).
People on the Basal Plus regimen experienced fewer hypoglycemic events
(blood glucose <50 mg/dL [2.8 mmol/L] + symptoms per patient year
[Glarg +1 glulisine = 0.8+/-0.2; p>0.001 and Glarg+0-3 glulisine =
0.9+/-0.2; p<0.001] vs. premixed [1.9+/-0.3]).
The Basal Plus approach not only emulates physiological insulin
secretion but also allows the flexibility of separate adjustment of
basal and prandial insulin doses.
Commenting on the results, study investigator Dr Matthew Riddle, Oregon
Health & Sciences University, said: "Adding a single injection of
prandial insulin to titrated basal insulin is a logical and
patient-friendly way to intensify therapy for type 2 diabetes. Now we
have shown this approach was as effective, yet caused less hypoglycemia
than twice-daily premixed insulin. In addition, this basal plus one
prandial injection method compared favorably as a regimen permitting
full basal-bolus treatment."
First data from the trial have previously been presented at the American
Diabetes Association's 71st Scientific Sessions, 2011.
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
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).
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For further information:
Global Diabetes Division Communications
Dr. Tilmann Kiessling