Exenatide Effective for Type 2 Diabetes 

“Exenatide significantly reduced HbA1c in patients with type 2 diabetes failing maximally effective doses of a sulfonylurea. "Sulfonylureas, a class of commonly prescribed antidiabetic drugs, are generally safe and efficacious in monotherapy and in combination with other oral agents and insulin in patients with type 2 diabetes," write John B. Buse, MD, PhD, from the University of North Carolina School of Medicine in Chapel Hill, and colleagues from the Exenatide-113 Clinical Study Group. "However, hypoglycemia and weight gain often accompany their use, and sulfonylurea therapy eventually fails to provide adequate glycemic control in the majority of patients with type 2 diabetes. Exenatide (exendin-4) is a 39–amino acid peptide incretin mimetic that exhibits glucoregulatory activities similar to those observed with the mammalian incretin hormone glucagon-like peptide (GLP)-1."

At 101 sites in the U.S., investigators in this triple-blind study enrolled 377 subjects with type 2 diabetes refractory to maximally effective doses of a sulfonylurea as monotherapy. Mean age was 55 ± 11 years, 60% of subjects were men, body mass index (BMI) was 33 ± 6 kg/m², and mean HbA1c level was 8.6% ± 1.2%.

After a four-week, single-blind, placebo lead-in period, subjects were randomized to receive 5 µg subcutaneous exenatide twice daily, before breakfast and dinner (groups A and B, respectively) or placebo. After four weeks of this regimen, the dose of exenatide in group B was increased to 10 µg twice daily. All subjects continued sulfonylurea therapy.

At week 30, HbA1c changes from baseline were –0.86 ± 0.11 in the 10-µg group, –0.46 ± 0.12 in the 5-µg arm, and 0.12% ± 0.09% in the placebo group (adjusted P < .001).

Of 237 evaluable subjects with baseline HbA1c levels greater than 7%, HbA1c after treatment was 7% or less in 41% of patients in the 10 µg group, 33% in the 5 µg group, and 9% in the placebo group (P < .001). Compared with placebo, the 10-µg group had decreased fasting plasma glucose concentrations (P < .05). Dose-dependent, progressive weight loss occurred in both exenatide groups, with an end-of-study loss in the 10-µg group of –1.6 ± 0.3 kg from baseline (P < .05 vs placebo).

Adverse events were typically mild or moderate; no severe hypoglycemia was observed; and the most frequent adverse events were gastrointestinal, especially nausea.

"Exenatide significantly reduced HbA1c in patients with type 2 diabetes failing maximally effective doses of a sulfonylurea," the authors write. "Exenatide was generally well tolerated and was associated with weight loss…. The incidence of hypoglycemic risk associated with sulfonylurea treatment increased with exenatide administration as overall glycemic control improved."

Exenatide’s mechanisms of action include glucose-dependent enhancement of insulin secretion, suppression of high glucagon secretion, and slowing of gastric emptying. It improves β-cell function, weight loss, and may have an insulin-sensitizing effect. Both 10 and 5 μg of exenatide twice daily improve glycemic control and are associated with weight loss over 30 weeks.

Diabetes Care. 2004;27:2628-2635

================================

Where’s your pedometer?

Not sure? Find out what you’re missing on the road to better health. A pedometer without a program is like a computer without any software.

https://www.rx4betterhealth.com/steptracker/