WASHINGTON, June 10 /PRNewswire-FirstCall/ -- Results from a new study presented at the American Diabetes Association's (ADA) 66th Annual Scientific Sessions found that a simple algorithm to adjust mealtime insulin based on pre-meal glucose patterns is just as effective as the more complex carbohydrate counting method -- a standard technique that many diabetes patients find difficult to use. The new algorithm may provide patients with an easier method to dose their mealtime insulin therapy.
After 24 weeks of combination therapy with rapid-acting Apidra(R) and 24- hour Lantus(R), patients using both the new mealtime dosing algorithm and the traditional carbohydrate counting method were able to achieve mean A1C levels of 6.6% (p<0.0001), helping the majority of patients achieve the ADA's recommended blood sugar control target of A1C<7%. Additionally, the rate of symptomatic hypoglycemia (blood glucose<50 mg/dl) was lower in the group that used the new algorithm (4.9 vs 8.0 events/patient year, p=0.02).
"This new dosing approach relies on a simple algorithm that allows patients to start with a fixed dose of mealtime glulisine and then adjust to target based on premeal glucose patterns. This is an easy way to dose and adjust mealtime insulin that should meet the needs of many patients who are not prepared to undertake the equally effective but more complex carbohydrate counting method," explained study author Richard M. Bergenstal, MD, executive director, International Diabetes Center, Park Nicollet Health Services, Minneapolis, MN. "Also, the A1C reductions seen in this study help further demonstrate that good glycemic control is possible and often associated with basal:bolus regimens. Basal:bolus regimens like the glulisine/glargine combination used in this trial simulate the normal physiologic insulin response that occurs in people without diabetes and there are many people with type 2 diabetes who would benefit from such a regimen."
About the Study
Two hundred and seventy-three subjects participated in this open-label, multicenter, randomized, 24-week study. The study compared the change in glycemic control, as measured by Hemoglobin A1c (HbA1c) from baseline to study week 24; in subjects receiving glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) vs a fixed bolus insulin regimen; with glargine as basal insulin in both arms of the study. All participants had a confirmed type 2 diabetes diagnosis with the disease uncontrolled on two or more insulin injections per day.
All participants were switched to basal/bolus therapy with once-daily glargine titrated to fasting blood glucose<95mg/dL and premeal glulisine to targets of <100 mg/dL pre- lunch/dinner and 130 mg/dL at bedtime +/- metformin. Premeal glulisine was adjusted weekly. One group used a simple algorithm to add 1, 2 or 3U based on premeal glucose patterns. The other group, which used carbohydrate counting, adjusted dose based on the I:C ratio.
Study Results
At the end of the 24-week period, A1C was significantly reduced in both arms (p<0.0001) from an initial 8.2% to a final 6.6% with no difference (-1.46% vs -1.59%, p=0.24) between the algorithm and carbohydrate counting groups, respectively. The algorithm group received significantly higher doses of glulisine (110.2 vs 94.3U, p=0.04) and glargine (103.4 vs 87.0U, p=0.0001) and had significantly less symptomatic hypoglycemia <50 mg/dL (4.9 vs 8.0 events/patient year, p=0.02) than the carbohydrate counting group.
No differences were observed for the proportion of participants achieving A1C<7% (73.0% vs 69.2%, p=0.7) or weight gain (3.7 vs 2.4 kg, p=0.06), for the algorithm and carbohydrate counting groups, respectively. Both groups concluded the study with a basal:bolus ratio of 50:50 and used 1.8-2 U/kg of insulin/day. Adverse events in each group were similar and included infection, gastrointestinal disorders and nervous system-related events.
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to convert glucose (sugar) into energy. It is estimated that more than 20 million Americans have diabetes, including 6.2 million who remain undiagnosed. At the same time, approximately half of those diagnosed are not achieving the general blood sugar control standard of A1C <7% recommended by the American Diabetes Association (ADA). The A1C test measures blood glucose levels over a two- to three-month period.
Important Safety Information for Apidra(R)
Apidra is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. Apidra has a more rapid onset of action and a shorter duration of action than regular human insulin. Apidra should normally be used in regimens that include a longer-acting insulin or basal insulin analog. Apidra is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Apidra or one of its excipients.
Apidra differs from regular human insulin by its rapid onset of action and shorter duration of action. When used as a mealtime insulin, the dose of Apidra should be given within 15 minutes before or within 20 minutes after starting a meal. Because of the short duration of action of Apidra, patients with diabetes also require a longer-acting insulin or insulin infusion pump therapy to maintain adequate glucose control. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength may result in the need for a change in dose. Concomitant oral antidiabetic treatment may need to be adjusted. As with all insulin preparations, the time course of Apidra action may vary in different individuals or at different times in the same individual and is dependent on site of injection, blood supply, temperature, and physical activity. Glucose monitoring is recommended for all patients with diabetes. Hypoglycemia is the most common adverse effect of insulin therapy, including Apidra. The timing of hypoglycemia may differ among various insulin formulations. Adverse events commonly associated with human insulin therapy include hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.
Please visit http://www.apidra.com/ for full prescribing information.
Important Safety Information for Lantus(R)
Lantus 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 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 is contraindicated in patients hypersensitive to insulin glargine or the excipients.
Hypoglycemia is the most common adverse effect of insulin, including Lantus. 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 include the following: lipodystrophy, skin reactions (such as injection-site reaction, pruritus, rash) and allergic reactions.
Please visit http://www.lantus.com/ for full prescribing information.
About sanofi-aventis
Sanofi-aventis 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. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY)
U.S. Contacts: Terri Pedone, +1-908-243-6578,
Terri.Pedone@sanofi-aventis.com
Amy Ba, +1-908-243-4261, Amy.Ba@sanofi-aventis.com
Source: Sanofi-aventis
CONTACT: U.S.: Terri Pedone, +1-908-243-6578,
Terri.Pedone@sanofi-aventis.com, or Amy Ba, +1-908-243-4261,
Amy.Ba@sanofi-aventis.com, both of Sanofi-aventis