Firms Report Phase III Data at 72nd American Diabetes Association Congress

Companies presenting late-stage data on their type 2 diabetes candidates at the 72nd American Diabetes Association Congress included Sanofi, Janssen Research & Development, Bristol-Myers Squibb and AstraZeneca. Sanofi  reported positive data from the the GetGoal Duo 1 and GetGoal L studies evaluating the once-daily GLP-1 agonist lixisenatide (Lyxumia®). The studies, in a total of nearly 1,500 patients, showed that the addition of lixisenatide significantly reduced HbA1c levels and as a result lowered postprandial glucose.

GetGoal Duo1 evaluated the addition of lixisenatide to treatment with insulin glargine and oral antidiabetic agents (primarily metformin) in patients with type 2 diabetes who were either new to insulin therapy or had already been receiving insulin therapy for an average of three years. GetGoal-L evaluated lixisenatide therapy in type 2 diabetes patients whose disease wasn’t adequately controlled on basal insulin with or without metformin.

Sanofi says it plans to file for regulatory approval of lixisenatide in the U.S. before the end of 2012. The firm submitted a marketing authorization application for the drug in Europe during November 2011.

Additionally, adult type 2 diabetes patients treated using the sodium glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin in addition to sitagliptin (with or without metformin) demonstrated significantly greater reductions in HbA1c levels than those treated using sitagliptin-based therapy alone, according to Phase III data reported by partners Bristol-Myers Squibb (BMS) and AstraZeneca. The addition of dapagliflozin to sitagliptin (with or without metformin) also led to significant reductions in total body weight and fasting plasma glucose levels that were maintained over the 48-week trial and extension period.

Dapagliflozin has been submitted for review to both FDA and the European regulatory body. In January FDA issued a complete response letter requesting additional clinical data to enable more evaluation of the drug’s benefit-risk profile. In April EMA's Committee for Medicinal Products for Human Use issued a positive opinion for dapagliflozin as an adjunct to diet and exercise in combination with other glucose-lowering drugs including insulin and as monotherapy in metformin-intolerant patients. A final ruling by the EC is pending.

Janssen Research & Development presented positive data from five Phase III studies evaluating canagliflozin as monotherapy and as add-on combination therapy in patients with type 2 diabetes. Two of the studies comparing canagliflozin with either sitagliptin or glimepiride showed that treatment with Janssen’s once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor resulted in significantly greater reductions in HbA1c levels.

The global Phase III canagliflozin clinical program has enrolled over 10,300 patients in nine studies to evaluate the drug in patients exhibiting the full spectrum of type 2 diabetes severity, from those who require diet and exercise only to those requiring insulin injections, as well as studies in older patients and those with moderate renal impairment or who were at risk of cardiovascular disease. Janssen submitted an NDA to FDA for canagliflozin at the end of May. The firm licensed rights to the drug in territories including North America and Europe from Mitsubishi Tanabe Pharma.