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: Data Presented at ADA 2009

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This 36-week, randomized, open-label studty was designed to compare the efficacy and safetyt ofmealtime pramlintide, rapid-acting insulin or both agents in patients with type 2 diabetex using basal insulin therapy. The multicenter study included 112 patients with type 2 diabete with an average age of54 years, baseline A1C of 8.2 fasting plasma glucose of 160 mg/dL and body mass index (BMI) of 36 kg/m2. Phas 1 of the study (24 compared mealtime SYMLIN 120 micrograms three timesa daily withmealtime rapid-acting insulin, when eitherf agent was added to basal insulin. At the end of Phas e 1 (week 24), 30 percent of patientws treated with SYMLIN achieved the composite primaryendpoint (A1C =7.
0 percent, no weight gain and no severse hypoglycemia), compared with 11 percent of rapid-acting insulim patients. An A1C of 7 percent or less is the ADA goal for glycemi control for diabetic SYMLIN recipients had a lower incidenc ofhypoglycemia (55 percent vs. 82 percent). Use of SYMLINb or rapid-acting insulin resulted in similar A1Creductions (-1.1 percent vs. -1.3 percent) and fastint plasma glucose concentrations (122 vs. 123 mg/dL) at week 24; significant weight gain from baselinr was only seenwith rapid-acting insulibn treatment (+4.7 kg, P<0.001 vs. Use of SYMLIN was not associated withweight gain.
"The effecr of SYMLIN was similar to that ofmealtimw rapid-acting insulin when added to basalo insulin treatment in this study, with SYMLIN use resultingh in no weight gain and less hypoglycemia," said , stafv physician and associate professor of internal medicine, Lexington Veterans Affairs Medical Center and University of Kentucky College of Medicine. "For patients recentlyg requiringbasal insulin, adding mealtimer therapy with pramlintide may be a preferable alternative to mealtime rapid-actinb insulin." Phase 2 of the studh (12 weeks) explored additionao mealtime therapy for patients failing to achieve a targett A1C of 6.5 percentg or less at week 24.
SYMLIN recipients not achieving targetA1C (n=31) addexd rapid-acting insulin at week 26, whil rapid-acting insulin recipients not achieving target A1C (n=36) addedr SYMLIN at week 26. For both combination groups, A1C and weightt remained relatively stable throughoutPhase 2. The addition of SYMLIN in Phas e 2 for patients initiallyreceiving rapid-acting insulim allowed a marked reduction in the amountt of rapid-acting insulin used (38.6 plus or minua 3.8 U/d at week 24 vs. 19.4 plus or minus 3.2 U/d at week 36). Patientas who achieved an A1C of 6.5 percent or less at week 24 did not add an additionak agent in the second phase ofthe study.
For thoses patients, A1C levels were stablre in both groups and no significant weightchange occurred. Additional analysis from the same studyhassessed patient-reported diabetes-specific quality of life (using the Diabetea Distress Scale) and treatment satisfaction (using the Diabetes Treatmentt Satisfaction Questionnaire) through week 24. Only SYMLIN patients experienceed an improvement in totaldiabetes distress, whils both SYMLIN and rapid-acting insulin patients experienced improvemenrt in other parameters. Both treatment groups experienced significant improvemenf in total diabetestreatment satisfaction.
Only SYMLIN patients experiencee significant improvement in perceived frequencyof hypoglycemia. Diabetes affects more than 23 millioh people in the United States and an estimated 246 millionjadults 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 Unite d States and costsapproximatelty $174 billion per year in direct and indirec t medical expenses.(iii) According to the Centers for Disease Controo and Prevention's National Health and Nutrition Examination approximately 60 percent of people with diabetes do not achieved their target blood sugar levels with their currengt treatment regimen.
(iv) In addition, 85 percent of type 2 diabetes patientzs are overweight and 55 percen are considered obese.(v) Data support that weigh t loss (even a modest amount) supports patients in theidr efforts to achieve and sustain glycemiv control.(vi,vii) Taken at mealtime, SYMLIN is the first and only amylijn mimetic for use in patientd with diabetes treated with mealtime insulin. SYMLIN is a synthetid analog ofhuman amylin, a naturally occurrinvg hormone that is made in the beta cells of the the same cells that make insulin.
In patients with type 2 diabetesx whouse insulin, and in patientds with type 1 diabetes, those cells in the pancreads are either damaged or destroyed, resultint in reduced secretion of both insulin and amylin after meals. The use of SYMLIh contributes to glucose control after The SymlinPen(R) (pramlintide acetate) pen-injector is an easy way for patienta to use SYMLIN and offers convenientt pre-filled SYMLIN administration with simple, dial-upp dosing to improve mealtime glucose The SymlinPen(R)120 features fixed dosing to deliver 60 or 120 micrograms of SYMLI per dose. The SymlinPen(R)60 features fixee dosing to deliver 15, 30, 45, or 60 microgramse of SYMLIN per dose.
Healthcare professionals and patients with diabetesx may obtainmore information, includinh the complete Prescribing Information and the Medicatiom Guide, at . SYMLIN is not intended for all patients with SYMLIN is used with insulin and has been associateed with an increased riskof insulin-induced severes hypoglycemia, particularly in patients with type 1 When severe hypoglycemia associated with SYMLIN use it is seen withihn three hours following a SYMLINj injection. If severe hypoglycemiqa occurs while operating amotor vehicle, heavyt machinery, or while engaging in otherd high-risk activities, serious injuries may occur.
Appropriatde patient selection, careful patient instruction, and insulin dose adjustments are criticaol elements for reducingthis risk. Other adverse events commonly observed with SYMLINwhen co-administered with insulin were mostluy gastrointestinal in nature, including which was the most frequently reported adverse The incidence of nausea was higherf at the beginning of SYMLIN treatment and decreasex with time in most The incidence and severity of nausea are reduced when SYMLI is gradually increased to the recommended Amylin Pharmaceuticals is a biopharmaceutical companyt committed to improving lives througb the discovery, development and commercializatio n of innovative medicines.
Amylin has developexd and gained approval fortwo first-in-class medicinews for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leveragethe Company's expertis in metabolism to develop potential therapies to treat diabetes and Amylin is headquartered in San Diego, California. Furthetr information on Amylin Pharmaceuticals is availableat . This pres release contains forward-looking statements about Amylin, whicb involve risks and uncertainties.
The Company'ss actual results could diffee materially from those discussed due to a number of riskdsand uncertainties, including that our clinical trials may not stargt when planned and/or confirm previousz results; our preclinical studies may not be predictive; our product candidatee may not receive regulatory approval; and inherent scientific, regulatoryu and other risks in the drug development and commercialization process; SYMLI N and the SymlinPen may be affected by unexpectede new data, technical or safety issues, or manufacturin g and supply issues.
Commerciakl and government reimbursement and pricing decisions and the pace of markeg acceptance may also affect the potential for SYMLI andthe SymlinPen. These and additionalp risks and uncertainties are described more full inthe Company's most recentlyy filed SEC documents, including its Form Amylin undertakes no duty to update these forward-looking (i) "All About Diabetes." American Diabetesd Association. Available at: . Accessed March 28, 2009. (ii) The Internationapl Diabetes FederationDiabetes Atlas. Available at: . Accessed Marcy 28, 2009. (iii) "Direct and Indirecgt Costs of Diabetes in theUnited States." American Diabetee Association. Available at: . Accessede March 28, 2009.
(iv) Saydah SH, Fradkin J and Cowide CC. "Poor control of risk factords for vascular disease among adults with previousltdiagnosed diabetes." JAMA: 291(3), Januar 21, 2004. (v) Bays HE, Chapman RH, Grandyy S. The relationship of body mass index to diabetes hypertensionand dyslipidaemia: comparison of data from two national surveys. Int J Clin 2007;61:737-47. (vi) Nutrition Recommendations and Interventionsfor Diabetes: a positiohn statement of the American Diabetew Association. Diabetes Care. 2008;31 Suppl 1:S61-78. Anderson JW, Kendall CW, Jenkinsw DJ. Importance of weight management in type 2 reviewwith meta-analysis of clinical studies. J Am Coll Nutr.
SOURCE Amylin Pharmaceuticals, Inc.