B-MS/AZ drug shows improvements across all glycemic measures

Results from a 12-week, Phase III study presented at the meeting of the American Diabetes Association suggest that the sodium glucose  co-transporter 2 inhibitor dapagliflozin, under joint development by the  USA's Bristol-Myers Squibb and Anglo-Swedish AstraZeneca, produced  improvements across all key glycemic measures studied in type 2 diabetes  patients.

The randomized, double-blind, placebo-controlled study enrolled 71  individuals with type 2 diabetes whose HbA1c was greater than or equal  to 7.5% and less than or equal to 10% with inadequately-controlled type  2 diabetes, despite treatment with U100 insulin plus one or two baseline  oral antidiabetes medications. The primary endpoint of the study  compared mean HbA1c change from baseline for each dapagliflozin  treatment arm compared to placebo. The secondary endpoints included  proportion of individuals achieving the ADA recommended HbA1c target of  less than 7%, proportion of peaople seeing HbA1c decrease from baseline  of at least 0.5% and fasting plasma glucose change from baseline as  compared to placebo.

After 12 weeks, individuals receiving dapagliflozin demonstrated an  adjusted mean decrease in HbA1c from baseline of 0.61% for dapagliflozin  10mg and 0.69% for dapagliflozin 20mg, compared to an increase of 0.09%  for placebo. 13% of individuals treated with dapagliflozin achieved  HbA1c of less than 7% after the 12-week treatment period in the 10mg arm  and 4.3% for 20mg, compared to 5.3% for placebo. The percentage of  individuals who achieved HbA1c decrease from baseline of at least 0.5%  was 65.2% for dapagliflozin 10mg and 65.2 dapagliflozin 20mg, compared  to 15.8% for placebo. The change from baseline in FPG at 12 weeks was  +2.4 mg/dL for dapagliflozin 10 mg and -9.6 mg/dL for dapagliflozin 20  mg, compared to +17.8 mg/dL for placebo.