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Study Shows Humalog Mix75/25 Insulin Provides Better Blood Sugar Control Over NPH Insulin in Type 2 Diabetes Patients.

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INDIANAPOLIS--(BW HealthWire)--June 15, 2002

People with type 2 diabetes who are treated with Humalog(R) Mix75/25(TM) (75% insulin lispro protamine suspension, 25% insulin lispro injection (rDNA origin)) achieve better blood sugar (glucose) control than those treated with NPH insulin, according to a study released today at the annual scientific sessions of the American Diabetes Association (ADA) in San Francisco.

The study compared the effects of combining either NPH or Humalog Mix75/25 with an oral anti-diabetic agent (metformin) to see which resulted in better post-meal (postprandial) and long-term (HbA1c) blood glucose levels. Patients using Humalog Mix75/25 achieved better control compared with those using NPH.

"Many type 2 patients need insulin in combination with oral agents for optimal glycemic control," said Dr. John Holcombe, medical advisor for Eli Lilly and Company and lead researcher for the study. "This study demonstrated that an insulin regimen of twice-daily Humalog Mix75/25 provided superior glycemic control compared to twice-daily NPH therapy."

Study Design

The study examined 366 patients with type 2 diabetes who took at least two oral agents yet demonstrated poor glucose control (HbA1c greater than 8%). Patients were randomized to receive metformin and either Humalog Mix75/25 before dinner or NPH at bedtime for six months. A second morning insulin injection was provided to patients between the second and fifth months if pre-established glycemic targets were not met. Subgroups were then determined based on one or two injections at the end of the study.

Study Results

Similar number of patients in the NPH (66 percent) and Humalog Mix75/25 (69 percent) groups required second insulin injections. Among the groups requiring two injections, those on Humalog Mix75/25 demonstrated significant improvement in HbA1c and 2-hour postprandial glucose levels over patients treated with NPH. Although patients remaining on the once daily insulin injection saw no significant difference in insulin treatments with respect to HbA1c, the glucose levels after dinner were significantly lower.

Several studies(1) have shown that improving postprandial blood glucose levels and overall blood glucose levels helps patients avoid some of the serious complications of diabetes, such as blindness, kidney damage and nerve damage that can lead to limb amputations.

Study researchers will conduct a poster session to discuss their findings at the annual scientific sessions of the American Diabetes Association in San Francisco on Saturday, June 15, 2002 from 10:00 a.m.-6:15 p.m.

About Humalog Mix75/25

Humalog Mix75/25 is for use in patients with diabetes to control high blood sugar. Humalog Mix75/25 starts lowering blood glucose more quickly than regular human insulin, allowing for convenient dosing immediately before a meal (within 15 minutes). By combining the benefits of the rapid-acting Humalog(R) with an intermediate -- acting insulin, Humalog Mix75/25 provides blood glucose control throughout the day -- at mealtime, between meals and at nighttime. It is available by prescription only. Humalog Mix75/25 is not indicated for use with metformin.

Important Safety Information

Potential side effects associated with the use of all insulins include low blood sugar, weight gain, low blood potassium, changes in fat tissue at the site of injection, and allergic reaction, both general and local. Humalog Mix75/25 should not be mixed with another insulin. Starting or changing insulin therapy should be done cautiously and only under medical supervision.

Eli Lilly and Company

Lilly, a leading innovation -- driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

(1) The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New Eng J Med. 1993; 329(14): 977-986.

UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998; 352: 837-852.

Yasuo Ohkubo (Kumamoto University). Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin dependent diabetes: A randomized prospective 6 year study. Diabetes Research and Clinical Practice. 1995; 28: 103-117.

Note to Editors: In "HbA1c", 1c should read subscript.
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