New data presented at the ADA's Annual Scientific Sessions demonstrated the
value of beginning insulin promptly when glycemic targets are not achieved
with diet, exercise and oral medications alone
SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Results from a new
study presented at the American Diabetes Association's (ADA) 68th Annual
Scientific Sessions reinforce the importance of promptly initiating insulin
treatment when patients with type 2 diabetes are unable to achieve
recommended glycemic targets with diet, exercise and oral diabetes
medications alone. In the TULIP (Testing the Usefulness of Lantus(R) when
Initiated Promptly in patients with type 2 diabetes) clinical study, 66
percent of patients who began treatment with the long-acting, basal insulin
Lantus(R) (insulin glargine [rDNA origin] injection) achieved A1C <7%, the
ADA's recommended target for glycemic control, while only 38 percent of
patients from the lifestyle management arm were able to achieve the
recommended target levels.
In an effort to help guide treatment decisions, the ADA and European
Association for the Study of Diabetes (EASD) developed a Consensus
Algorithm for Type 2 Diabetes that calls for healthcare providers and
diabetes patients to initiate insulin therapy when A1C <7% is not achieved
with oral medications and lifestyle management alone. However, physicians
typically wait for A1C to approach 9% before adding insulin. In general,
every percentage point drop in A1C blood test results (e.g., from 8.0% to
7.0%) reduces the risk of microvascular complications (eye, kidney, and
nerve diseases) by 40%.
The most common side effect of any insulin, including Lantus(R), is
hypoglycemia, which may be serious. In the Lantus(R) arm of the TULIP
trial, there were 4.2 +/- 6.6 (p<0.0001) cases of symptomatic, 0.7 +/- 2.1
(p=0.0011) cases of nocturnal and 0.04 +/- 0.35 (p=0.147) cases of severe
hypoglycemia events reported per patient year. However, no patients dropped
out of the trial due to hypoglycaemia.
"When glycemic targets are not achieved with diet, exercise and oral
medications given at maximum tolerated dose, patients with type 2 diabetes
have reached a critical moment in the lifecycle of their condition," said
Andre Grimaldi, MD, Professor Diabetes Department Head, Pitie-Salpetriere
Hospital, Paris, France. "The results observed in TULIP demonstrate the
value of following the ADA/EASD treatment recommendations by initiating
basal insulin therapy in a timely manner."
About the TULIP Study
TULIP is a 9-month, 12-visit, open-label, multinational, multicenter,
randomized study to evaluate starting Lantus(R) or intensifying lifestyle
management in type 2 diabetes patients aged 40-75 years, body mass index
(BMI) 24-35 kg/m2 and A1C 7-8%, treated with maximum doses of metformin and
sulfonylurea for greater than or equal to 2 years. Lantus(R) was injected
once-daily and titrated to capillary fasting blood glucose 70-100 mg/dL. In
the lifestyle management arm, dietary and physical activity counseling
recommended stable weight for people with BMI<27 kg/m2 or weight loss of 3
kg for patients with BMI greater than or equal to 27 kg/m2. 215 patients
were randomized to Lantus(R) (n=106) or lifestyle management (n=109).
The primary objective was the percentage of patients achieving A1C <7%
at endpoint. Secondary endpoints included changes in A1C and fasting plasma
glucose (FPG), and hypoglycemia incidence.
211 (52.6% male) patients were randomized and treated; mean (
+/-standard deviation) age 60.7 +/- 7.9 years, weight 84.5 +/- 13.1 kg, BMI
29.9 +/- 3.5 kg/m2 and A1C 7.6 +/- 0.4%. More patients reached A1c <7% (66
vs 38%; p<0.0001) or <6.5% (34 vs 11%; p<0.0001) with Lantus(R) versus
lifestyle management. In contrast to the Lantus(R)-treated group, the
lifestyle management-treated group showed a decrease in weight (+0.9 +/-
2.9 vs -2.5 +/- 3.2 kg; p<0.0001) as well as the expected lower
hypoglycemia.
Results for hypoglycemia, A1C, FPG and weight are shown in the table.
A1C, FPG, body weight, insulin dose and hypoglycemia
Lantus(R) LM p
(n=103) (n=108)
% of <7% at
patients endpoint; 66; 38;
with A1C at <6.5% at <0.0001;
endpoint endpoint 34 11 <0.0001
Baseline; 7.6 +/- 0.3; 7.5 +/- 0.4;
A1C (%) Endpoint; 6.8 +/- 0.7; 7.3 +/- 0.9; <0.0001*
Change -0.8 +/- 0.7 -0.2 +/- 0.9
Baseline; 170 +/- 34; 167 +/- 27;
FPG (mg/dL) Endpoint; 122 +/- 33; 161 +/- 41; <0.0001*
Change -50 +/- 47 -5 +/- 39
Baseline; 85.0 +/- 12.5; 84.0 +/- 13.7;
Weight (kg) Endpoint; 86.0 +/- 13.4; 81.5 +/- 13.5; <0.0001*
Change +0.91 +/- 2.9 -2.5 +/- 3.2
Daily Starting
Lantus(R) insulin
dose (U/kg) dose; 0.12 +/- 0.05; n/a;
Endpoint 0.27 +/- 0.15 n/a n/a
Hypoglycemia
(events Symptomatic; 4.2 +/- 6.6; 2.0 +/- 7.8; <0.0001;
patient per Nocturnal; 0.7 +/- 2.1; 0.3 +/- 2.1; 0.0011;
year) Severe 0.04 +/- 0.35 0.00 +/- 0.00 0.147
Results are given for all randomized and treated patients; 4 patients
(Lantus(R), 3; LM, 1) were randomized but not treated. Results are means
+/- standard deviation; *p value for between-group difference in baseline
to endpoint change; FPG=fasting plasma glucose; LM=lifestyle management;
n/a=not applicable
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not
produce or properly use insulin -- the hormone needed to transport glucose
(sugar) from the blood into the cells of the body for energy. More than 230
million people worldwide are living with the disease. This number is
expected to rise to a staggering 350 million within 20 years. It is
estimated more than 20 million Americans have diabetes, including an
estimated 6.2 million who remain undiagnosed.
At the same time, approximately 43% of those diagnosed are not
achieving the blood sugar control target of A1C <7% recommended by the
American Diabetes Association (ADA).
About sanofi-aventis
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