Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and W...(and bloodpressure levels improved. Systo...),Health

Date:6/7/2008

and blood pressure levels improved. Systolic blood pressure decreased from baseline to endpoint by -3.7+/-1.2 mm Hg in the 5 mcg exenatide group (P=0.037; vs placebo) and also -3.7+/-1.2 mm Hg in the 10 mcg exenatide group (P=0.037; vs placebo), compared with -0.3+/-1.2 mm Hg for placebo (means +/- SEM). Diastolic blood pressure decreased from baseline to endpoint by -0.8+/-0.7 mm Hg in the 5 mcg exenatide group (P=0.619; vs placebo) and -2.3+/-0.7 mm Hg in the 10 mcg exenatide group (P=0.046; vs placebo), compared with -0.3+/-0.7 mm Hg for placebo (means +/- SEM).

There was an incidence of reported nausea in both the 5 mcg and 10 mcg arms of 3 and 13 percent, respectively, which is a lower incidence than what was observed in previous studies, where exenatide has been used in combination with other diabetes therapies. There were no instances of severe hypoglycemia. The overall incidence of hypoglycemia was similar to that seen in studies where exenatide was used in conjunction with metformin only.

Study Population

The 24-week, randomized study included 232 patients with type 2 diabetes who were not achieving adequate glucose control using diet and exercise without previous use of antidiabetes agents. Study participants were randomized to receive subcutaneous injections of placebo, 5 mcg exenatide, or 10 mcg exenatide twice daily without taking any oral antidiabetes agents. Patients randomized to 10 mcg exenatide received 5 mcg injections for the first four weeks, and increased to 10 mcg injections for the final 20 weeks.

About BYETTA(R) (exenatide) injection

BYETTA is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by peop
'/>"/>

SOURCE Eli Lilly and Company Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7
Related medicine technology :

1. TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity Without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008)
2. Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
3. Multiple Clinical Trials of VELCADE(R) (Bortezomib) for Injection Based Therapies Demonstrate High Complete Remission Rates in Patients with Newly Diagnosed Multiple Myeloma
4. VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma
5. New Eloxatin(R) (oxaliplatin injection) Prescribing Information in the U.S. Includes Six-Year Overall Survival Data
6. Ikaria Completes Dosing of Phase 1a Clinical Study for IK-1001 (Sodium Sulfide) for Injection
7. New Data Support High Complete Remission Rates With VELCADE(R) (Bortezomib) for Injection Based Therapies in Patients With Newly Diagnosed Multiple Myeloma
8. Patients Treated with Risperidone Long-Acting Injection had a Significantly Longer Time to Relapse Compared to Quetiapine in International Clinical Study
9. CorMatrix(R) Announces Intramyocardial Injection of Emulsified ECM Technology(TM) Demonstrates Enhanced Angiogenesis and Improved Cardiac Function in a Preclinical Model
10. Circulation Publishes Data Showing KYNAPID(TM) (Vernakalant Hydrochloride) Injection Rapidly Converted Short-Duration Atrial Fibrillation to Sinus Rhythm
11. Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review