GSK's news came from five long-term Phase IIIstudies (Harmony 1 to Harmony 5) comparing albiglutide, an investigationalglucagon-like peptide receptor agonist (GLP-1), to placebo and a range ofactive comparators: insulin, a sulphonylurea, a thiazolidinedione,and a dipeptidyl peptidase four inhibitor.
The primary efficacy endpoint for these studieswas the change from baseline in HbA1c compared to placebo and/or activecomparators assessed after one or two years of treatment. Secondary endpointsincluded fasting plasma glucose and weight. These studies were specificallydesigned to assess durability of albiglutide effect on HbA1c and othercontinuous variables when used in various combination therapies, at differentstages of the disease, and in various degrees of renal impairment. Albiglutideachieved the primary efficacy endpoint in these five studies, although ahierarchical analysis of noninferiority to pioglitazone was not met in onestudy. The most commonly reported adverse reactions in these studies weregastrointestinal complaints, primarily nausea and diarrhoea and injection sitereactions.
Albiglutide is a GLP-1 receptor agonist for thetreatment of type 2 diabetes—and currently undergoing regulatory review for suchtreatment in the United States and European Union—that is designed foronce-weekly subcutaneous dosing. GLP-1 is a peptide that is normally secretedfrom the gastrointestinal tract during a meal which in turn helps releaseinsulin to control blood sugar elevations after eating. In people with type 2diabetes, GLP-1 secretion in response to a meal is reduced or absent.
Sanofi, for its part, announced Phase III clinicaldata that showed lixisenatide, an investigational once-daily prandial GLP-1receptor agonist, decreased HbA1c by reducing postprandial glucose daytimeexposure when added to a standard of care that includes basal insulin with orwithout oral anti-diabetic agents. Lixisenatide is for the treatment of adultswith type 2 diabetes.
Sanofi also noted that it expects to seekregulatory approval for its next-generation U300 insulin in the United Statesand Europe during the first half of 2014, following the results of two late-stage tests expected by the end of this year. Phase III study results thusfar have indicated equivalent blood sugar control with fewer night-time lowblood sugar events compared to Lantus (insulin glargine [rDNA origin]injection).
Furthermore, Sanofi also noted around the sametime that it intends to start late-stage tests in the first half of 2014 for apen-shaped device called the LixiLan pen that combines two diabetes treatments—Lantusand Lyxumia—and could help patients better control blood sugar levels.
For its part, Elcelyx reportedpositive data for NewMet, the company's proprietary delayed-release formulationof metformin, in type 2 diabetes. According to the Phase IIa data from thecompany, NewMet has better glucose-lowering effects than metformin. Also, thesignificantly lower metformin plasma concentration observed with NewMetsuggests that it might be safely used by patients with moderate and severerenal impairment, a population of patients that is unable to use currentlyavailable metformin formulations due to the risk of lactic acidosis caused by toomuch metformin in the blood.
Finally, there was the news that patients takingEli Lilly's experimental diabetes drug dulaglutide lost weight and had sideeffects that were manageable, based on recent data from three final-stageclinical trials. Lilly released top-line results from the company-sponsoredtrials last year, when it reported more patients taking the therapy had bloodglucose levels indicating their disease was under control than those given Januviaand Byetta. The company plans to submit the drug to U.S. regulators forapproval by the end of this year.