Amylin Pharmaceuticals

About: Amylin Pharmaceuticals is a based out in . It is known for research contribution in the topics: Amylin & Exenatide. The organization has 579 authors who have published 601 publications receiving 41385 citations.

Effects of Exenatide (Exendin-4) on Glycemic Control and Weight Over 30 Weeks in Metformin-Treated Patients With Type 2 Diabetes

Abstract: OBJECTIVE —This study evaluates the ability of the incretin mimetic exenatide (exendin-4) to improve glycemic control in patients with type 2 diabetes failing to achieve glycemic control with maximally effective metformin doses. RESEARCH DESIGN AND METHODS —A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients. In all, 272 patients completed the study. The intent-to-treat population baseline was 53 ± 10 years with BMI of 34.2 ± 5.9 kg/m 2 and HbA 1c of 8.2 ± 1.1%. After 4 weeks of placebo, subjects self-administered 5 μg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 μg exenatide, or placebo subcutaneously twice daily for 26 weeks. All subjects continued metformin therapy. RESULTS —At week 30, HbA 1c changes from baseline ± SE for each group were −0.78 ± 0.10% (10 μg), −0.40 ± 0.11% (5 μg), and +0.08 ± 0.10% (placebo; intent to treat; adjusted P 1c ≤7% ( P P CONCLUSIONS —Exenatide was generally well tolerated and reduced HbA 1c with no weight gain and no increased incidence of hypoglycemia in patients with type 2 diabetes failing to achieve glycemic control with metformin.

Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Sulfonylurea-Treated Patients With Type 2 Diabetes

Abstract: OBJECTIVE —This study evaluated the ability of the incretin mimetic exenatide (exendin-4) to improve glycemic control in patients with type 2 diabetes failing maximally effective doses of a sulfonylurea as monotherapy RESEARCH DESIGN AND METHODS —This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the US After a 4-week, single-blind, placebo lead-in period, 377 subjects were randomized (60% men, age 55 ± 11 years, BMI 33 ± 6 kg/m 2 , HbA 1c 86 ± 12% [±SD]) and began 4 weeks at 5 μg subcutaneous exenatide twice daily (before breakfast and dinner; arms A and B) or placebo Subsequently, subjects in arm B were escalated to 10 μg bid exenatide All subjects continued sulfonylurea therapy RESULTS —At week 30, HbA 1c changes from baseline were −086 ± 011, −046 ± 012, and 012 ± 009% (±SE) in the 10-μg, 5-μg, and placebo arms, respectively (adjusted P 1c > 7% ( n = 237), 41% (10 μg), 33% (5 μg), and 9% (placebo) achieved HbA 1c ≤ 7% ( P P P CONCLUSIONS —Exenatide significantly reduced HbA 1c in patients with type 2 diabetes failing maximally effective doses of a sulfonylurea Exenatide was generally well tolerated and was associated with weight loss

Stability of Protein Pharmaceuticals: An Update

Abstract: In 1989, Manning, Patel, and Borchardt wrote a review of protein stability (Manning et al, Pharm Res 6:903-918, 1989), which has been widely referenced ever since At the time, recombinant protein therapy was still in its infancy This review summarizes the advances that have been made since then regarding protein stabilization and formulation In addition to a discussion of the current understanding of chemical and physical instability, sections are included on stabilization in aqueous solution and the dried state, the use of chemical modification and mutagenesis to improve stability, and the interrelationship between chemical and physical instability