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Use of Mealtime Pramlintide Added to Basal Insulin Showed Similar Improvements in Glycemic Control Compared to Rapid-Acting Insulin, With Lower Risk of Hypoglycemia and Without Weight Gain

Posted on: Saturday, 6 June 2009, 17:30 CDT

Additional Analyses Showed Pramlintide Improved Treatment Satisfaction and Quality of Life

NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced data showing that the use of mealtime SYMLIN(R) (pramlintide acetate) injection improved glucose control, treatment satisfaction and quality of life for patients with type 2 diabetes. These findings were detailed in oral and poster presentations at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.

This 36-week, randomized, open-label study was designed to compare the efficacy and safety of mealtime pramlintide, rapid-acting insulin or both agents in patients with type 2 diabetes using basal insulin therapy. The multicenter study included 112 patients with type 2 diabetes with an average age of 54 years, baseline A1C of 8.2 percent, fasting plasma glucose of 160 mg/dL and body mass index (BMI) of 36 kg/m2.

Phase 1 of the study (24 weeks) compared mealtime SYMLIN 120 micrograms three times daily with mealtime rapid-acting insulin, when either agent was added to basal insulin. At the end of Phase 1 (week 24), 30 percent of patients treated with SYMLIN achieved the composite primary endpoint (A1C =7.0 percent, no weight gain and no severe hypoglycemia), compared with 11 percent of rapid-acting insulin patients. An A1C of 7 percent or less is the ADA goal for glycemic control for diabetic patients. SYMLIN recipients had a lower incidence of hypoglycemia (55 percent vs. 82 percent). Use of SYMLIN or rapid-acting insulin resulted in similar A1C reductions (-1.1 percent vs. -1.3 percent) and fasting plasma glucose concentrations (122 vs. 123 mg/dL) at week 24; however, significant weight gain from baseline was only seen with rapid-acting insulin treatment (+4.7 kg, P<0.001 vs. baseline). Use of SYMLIN was not associated with weight gain.

"The effect of SYMLIN was similar to that of mealtime rapid-acting insulin when added to basal insulin treatment in this study, with SYMLIN use resulting in no weight gain and less hypoglycemia," said Dennis Karounos, staff physician and associate professor of internal medicine, Lexington Veterans Affairs Medical Center and University of Kentucky College of Medicine. "For patients recently requiring basal insulin, adding mealtime therapy with pramlintide may be a preferable alternative to mealtime rapid-acting insulin."

Phase 2 of the study (12 weeks) explored additional mealtime therapy for patients failing to achieve a target A1C of 6.5 percent or less at week 24. SYMLIN recipients not achieving target A1C (n=31) added rapid-acting insulin at week 26, while rapid-acting insulin recipients not achieving target A1C (n=36) added SYMLIN at week 26. For both combination groups, A1C and weight remained relatively stable throughout Phase 2. The addition of SYMLIN in Phase 2 for patients initially receiving rapid-acting insulin allowed a marked reduction in the amount of rapid-acting insulin used (38.6 plus or minus 3.8 U/d at week 24 vs. 19.4 plus or minus 3.2 U/d at week 36).

Patients who achieved an A1C of 6.5 percent or less at week 24 did not add an additional agent in the second phase of the study. For those patients, A1C levels were stable in both groups and no significant weight change occurred.

Patient Reported Outcomes

Additional analysis from the same study assessed patient-reported diabetes-specific quality of life (using the Diabetes Distress Scale) and treatment satisfaction (using the Diabetes Treatment Satisfaction Questionnaire) through week 24. Only SYMLIN patients experienced an improvement in total diabetes distress, while both SYMLIN and rapid-acting insulin patients experienced improvement in other parameters. Both treatment groups experienced significant improvement in total diabetes treatment satisfaction. Only SYMLIN patients experienced significant improvement in perceived frequency of hypoglycemia.

About Diabetes

Diabetes affects more than 23 million people in the United States and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $174 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii)

About SYMLIN

Taken at mealtime, SYMLIN is the first and only amylin mimetic for use in patients with diabetes treated with mealtime insulin. SYMLIN is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin. In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. The use of SYMLIN contributes to glucose control after meals.

The SymlinPen(R) (pramlintide acetate) pen-injector is an easy way for patients to use SYMLIN and offers convenient pre-filled SYMLIN administration with simple, dial-up dosing to improve mealtime glucose control. The SymlinPen(R)120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. The SymlinPen(R)60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.

Healthcare professionals and patients with diabetes may obtain more information, including the complete Prescribing Information and the Medication Guide, at www.SYMLIN.com.

Important Safety Information for SYMLIN

SYMLIN is not intended for all patients with diabetes. SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is seen within three hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk.

Other adverse events commonly observed with SYMLIN when co-administered with insulin were mostly gastrointestinal in nature, including nausea, which was the most frequently reported adverse event. The incidence of nausea was higher at the beginning of SYMLIN treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN is gradually increased to the recommended doses.

About Amylin Pharmaceuticals

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California. Further information on Amylin Pharmaceuticals is available at http://www.amylin.com.

This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. The Company's actual results could differ materially from those discussed due to a number of risks and uncertainties, including that our clinical trials may not start when planned and/or confirm previous results; our preclinical studies may not be predictive; our product candidates may not receive regulatory approval; and inherent scientific, regulatory and other risks in the drug development and commercialization process; SYMLIN and the SymlinPen may be affected by unexpected new data, technical or safety issues, or manufacturing and supply issues. Commercial and government reimbursement and pricing decisions and the pace of market acceptance may also affect the potential for SYMLIN and the SymlinPen. These and additional risks and uncertainties are described more fully in the Company's most recently filed SEC documents, including its Form 10-Q. Amylin undertakes no duty to update these forward-looking statements.

(i) "All About Diabetes." American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed March 28, 2009.

(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed March 28, 2009.

(iii) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed March 28, 2009.

(iv) Saydah SH, Fradkin J and Cowie CC. "Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes." JAMA: 291(3), January 21, 2004.

(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.

(vi) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008;31 Suppl 1:S61-78.

(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.

SOURCE Amylin Pharmaceuticals, Inc.

Source: PR Newswire

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