Promising results for new GLP-1 analog
MedWire News: Results from a phase II study show that the novel glucagon-like peptide (GLP)-1 analog LY2189265 (LY) significantly improves glycemic control and body weight, and is generally well tolerated in obese patients with Type 2 diabetes.
The GLP-1 analogs exenatide and liraglutide have previously been shown to successfully lower glycated hemoglobin (HbA1c) and reduce body weight in patients with Type 2 diabetes, as reported by MedWire News.
The current dose-titration phase II study assessed the efficacy of LY for treatment of 262 overweight Type 2 diabetes patients with poor glycemic control despite being prescribed oral antihyperglycemic medication (OAM). The patients were aged a mean 57 years, had an average body mass index (BMI) of 33.9 kg/m2, and a mean HbA1c of 8.24% at baseline.
Guillermo Umpierrez (Emory University, Atlanta, Georgia, USA) and colleagues assigned the participants to once-weekly injections with placebo (n=66), LY 0.5 mg for 4 weeks then 1.0 mg for 12 weeks (n=?0.5/1.0), LY 1.0 mg for 16 weeks (n=?1.0/1.0), or LY 1.0 mg for 4 weeks then 2.0 mg for 12 weeks (n=?1.0/2.0). Patients continued their prior OAM regimen during the study, unless changes were required for management of hypoglycemia or hyperglycemia.
At the end of 16 weeks, HbA1c had decreased by 0.24%, 1.38%, 1.32%, and 1.59% in the placebo, LY 0.5/1.0, LY 1.0/1.0, and LY 1.0/2.0 groups, respectively. Fasting and postprandial blood glucose was also found to be significantly lower in all LY groups compared with the placebo group at study completion.
Weight loss ranged from 1.34 to 2.55 kg in the LY groups in a dose-dependent manner, and was significantly greater than in the placebo group at all doses.
Hypoglycemia was uncommon, at 0.8 episodes/patient/30 days or less, but was slightly more common in patients given LY than those given placebo during the first 4 weeks.
Similar to other drugs in the same class, the most common adverse events were gastrointestinal. Nausea, diarrhea, and abdominal distension each occurred in 13.8% of patients in the LY 1.0/2.0 group.
Notably, no significant differences in blood pressure or cardiovascular event rates were observed between the two groups.
"Larger studies of longer duration are warranted to further assess the effects of LY therapy in Type 2 diabetes," conclude the authors in the journal Diabetes, Obesity and Metabolism.
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By Helen Albert