Navigation Links
Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin

Results from a 24-week multi-center, randomized, open-label study presented

at ADA 2008

SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced data showing that the use of mealtime SYMLIN(R) (pramlintide acetate) injection with basal insulin therapy for 24 weeks resulted in more patients achieving diabetes treatment goals of improved glucose control without weight gain or hypoglycemia compared to the use of rapid-acting insulin (RAI) with basal insulin in patients with type 2 diabetes. The results were detailed in an oral presentation at the American Diabetes Association's (ADA) 68th Annual Scientific Sessions in San Francisco.

"These findings are promising because they suggest that treating a deficiency of the hormone amylin in type 2 diabetes can have a beneficial effect on glucose control even when mealtime insulin is not used," said Matthew Riddle, M.D., Professor of Medicine and Head of the Section of Diabetes, Division of Endocrinology at Oregon Health Sciences University and clinical trial investigator. "The effect of SYMLIN was similar to that of mealtime rapid-acting insulin when either was added to basal insulin treatment in this study, with SYMLIN use resulting in no weight gain and less hypoglycemia."

The study was designed to demonstrate improvement in pre-defined comprehensive diabetes treatment goals that included achieving a target A1C and experiencing no weight gain or episodes of severe hypoglycemia. Among those treated with mealtime SYMLIN, 1 in 3 achieved this composite set of goals while only 1 in 10 patients treated with RAI achieved the same results (30 percent vs. 11 percent; P<0.05). Mild or moderate hypoglycemia incidence was lower in SYMLIN-treated patients (55 percent) compared to RAI-treated patients (82 percent) and no severe hypoglycemia was experienced in either group.

At week 24, similar improvements in glucose control were achieved in the SYMLIN- and RAI-treated groups. SYMLIN-treated patients achieved an A1C reduction of 0.9 percent from baseline compared with a 1.1 percent reduction for RAI. Fasting glucose was also similar between groups. RAI treatment was associated with increased body weight (+9.3 pounds) while SYMLIN treatment was not associated with weight gain (-0.5 pound, P<0.001). The most common side effect associated with SYMLIN in the study was nausea (21 percent vs. 0 percent with RAI), which was primarily mild or moderate nausea and decreased with time.

Study Details

This 24-week multi-center, randomized, open-label study, called INSTEAD (INitiating Symlin Therapy: Evaluating Alternatives in Diabetes), compared the safety and efficacy of the addition of mealtime SYMLIN or RAI to basal insulin therapy for 24 weeks in 112 patients with type 2 diabetes. Basal insulin dosage was titrated throughout the study seeking a target fasting glucose of 70 to <100 mg/dL. Patients were randomized to receive either mealtime SYMLIN at a fixed dose of 120 micrograms at major meals or RAI titrated to achieve pre-meal blood glucose of >70 to <100 mg/dL. Patients who entered the study taking oral diabetes medicines continued with their usual regimen throughout the study. Average baseline A1C for the study population was 8.2 percent and body weight was approximately 233 pounds.

In a second phase of the study designed to further understand the complementary effects of RAI and SYMLIN, patients not achieving a target A1C of 6.5 percent or less began using both SYMLIN and RAI at mealtime. Results from this phase of the study will be presented in a future scientific forum.


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.

Pre-filled SymlinPen(R) (pramlintide acetate) pen-injector devices offer convenient SYMLIN administration with simple, fixed dosing to improve mealtime glucose control. SymlinPen(R) 120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. SymlinPen(R) 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.

Healthcare professionals and people with diabetes may obtain more information, including the complete Prescribing Information and the Medication Guide, at

Important Safety Information for SYMLIN(R)

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. This information is highlighted in a boxed warning in the SYMLIN prescribing information for healthcare professionals and in a medication guide for patients, which will be distributed by pharmacists.

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 Diabetes

Diabetes affects over 20 million Americans and is growing at three times the rate of population growth.(1) Approximately 4.5 million patients with diabetes use insulin. Diabetes is the fifth leading cause of death by disease in the United States.(1) Diabetes is a complex metabolic disease manifesting with a defect in the beta cells in the pancreas, resulting in a deficiency of both insulin and amylin secretion.(2) Poor control of blood sugar may result in severe long-term complications such as kidney failure, nerve damage, blindness, amputation and cardiovascular disease.(1)

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 with over 2,000 employees nationwide. Further information on Amylin Pharmaceuticals is available at

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 risks that the results of clinical trials may not be predictive of future results; that SYMLIN and SymlinPen may be affected by unexpected new data, technical issues, or manufacturing and supply issues; that new drug applications will not receive regulatory approval; and risks inherent in the drug development and commercialization process. Commercial and government reimbursement and pricing decisions and the pace of market acceptance may also affect the potential for SYMLIN and 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.

(1) "All About Diabetes." American Diabetes Association. Available at: Accessed June 4, 2008.

(2) Kruger D, Gatcomb P, Owen S. Clinical implications of amylin and

amylin deficiency. Diabetes Educ. 1999;25:389-397.

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared to Bare Metal Stents in Five-Year Randomized Clinical Trial With No Differences in Long-Term Safety
2. Five-Year Data From Taxus II Clinical Trial Highlights Safety and Efficacy of Taxus(R) Stent Compared to Bare-Metal Stent
3. Largest Study to Date Shows Significant Reductions in Risks of Blood Clots and Reintervention With CYPHER(R) Sirolimus-eluting Coronary Stent Compared to Taxus Stent
4. INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients
5. New Study of Concerta(R) Showed Significant Improvement of ADHD Symptom Management in Adults Compared to Placebo
6. Retrospective Analysis Finds That Initiation of Insulin Glargine in Patients With Type 2 Diabetes was Associated With a Lower Incidence Rate of Myocardial Infarction as Compared With NPH Insulin
7. Pharmions Amrubicin Shows Encouraging Results Compared to Standard of Care in Second Line Treatment of Small Cell Lung Cancer
8. TREANDA Significantly Improves Clinical Outcomes in Patients with Chronic Lymphocytic Leukemia Compared to Chlorambucil
9. Study Shows That Low-Molecular Weight Heparin (LMWH) was Associated with Reduced Hospital Costs of Venous Thromboembolism (VTE) Treatment Compared with Unfractionated Heparin (UFH)
10. TAXUS(R) Express(TM) Stent Shows Similarly Low Re-intervention Rates in Diabetic Patients Compared to Non-Diabetics in ARRIVE 1 and 2 registries
11. TAXUS(R) Stent Demonstrates Similar Outcomes in Diabetic Patients Compared to Non-diabetics in Pooled Analysis of TAXUS IV and V Trials
Post Your Comments:
(Date:11/26/2015)... november 2015 AAIPharma Services Corp./Cambridge ... investering aan van ten minste $15,8 miljoen ... het mondiale hoofdkantoor in Wilmington, ... in extra kantoorruimte en extra capaciteit voor ... behoeften van de farmaceutische en biotechnologische markten. ...
(Date:11/26/2015)... --> --> Juntendo University ... contrast weighting of MRI for patients with Multiple Sclerosis ... agreement with SyntheticMR in order to use SyMRI in clinical ... to generate multiple contrast images from a single scan and ... making it possible to both fine tune images and recreate ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new ... Japanese therapeutic drug monitoring market, including emerging tests, ...
Breaking Medicine Technology:
(Date:11/27/2015)... , ... November 27, 2015 , ... ... center software Q-Suite, announces the incorporation of Asterisk 11 LTS (Long Term Support) ... supported Asterisk 11 LTS brings Q-Suite 5.10 up-to-date with a version of Asterisk ...
(Date:11/26/2015)... ... November 26, 2015 , ... Inevitably when people think Thanksgiving, they also ... buy during the Black Friday and Cyber Monday massage chair sales to ... Internet high and low to find the best massage chair deals, they can see ...
(Date:11/26/2015)... , ... November 26, 2015 , ... ... Express Travel Representative. As a franchise owner, Somu now offers travelers, value and ... destination wedding packages, private cruise sales, as well as, cabin upgrades and special ...
(Date:11/26/2015)... NE (PRWEB) , ... November 26, 2015 , ... Jobs ... searched by healthcare professionals and offered by healthcare staffing agency Aureus Medical Group ... during the month of October 2015 among those searching for healthcare jobs through the ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... ... second medical opinion process, participated in the 61st annual Employee Benefits Conference. The ... and took place Sunday, November 8th through Wednesday, November 11th, 2015. The conference ...
Breaking Medicine News(10 mins):