Investigational SGLT2 inhibitor meets primary endpoint as add-on therapy in phase III trialNews - Sep. 16, 2016
These study results were presented for the first time during an oral session today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.
In this double-blind, randomised, placebo-controlled study, 463 patients with type 2 diabetes and a baseline A1C of 7.0 – 10.5 percent were randomised to receive ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo in a 1:1:1 ratio. In addition to meeting the primary endpoint of reducing A1C at 26 weeks, ertugliflozin also met the following key secondary endpoints in the study:
- A greater proportion of patients taking ertugliflozin 5 mg and 15 mg achieved the A1C treatment goal of less than 7.0 percent (32.1 percent and 39.9 percent, respectively) compared with the placebo group (17.0 percent) (p<0.001, for both comparisons based on adjusted odds ratios);
- Placebo-adjusted mean reduction in body weight of 4.4 lbs (2.0 kg) for the 5 mg dose and 3.7 lbs (1.7 kg) for the 15 mg dose (p<0.001, for both comparisons);
- Placebo-adjusted mean reductions in fasting plasma glucose (FPG) of 25.1 mg/dl (1.4 mmol/L) for the 5 mg dose and 31.3 mg/dl (1.7 mmol/L) for the 15 mg dose (p<0.001, for both comparisons);
- Placebo-adjusted mean reductions in systolic blood pressure of 2.9 mmHg (5 mg, p=0.019) and 3.9 mmHg (15 mg, p=0.002).
Overall adverse event (AE) rates were generally similar between ertugliflozin 5 mg (41.7 percent), ertugliflozin 15 mg (43.8 percent) and placebo (48.4 percent), with a similar rate of one or more serious AEs across all groups (4.5 percent for ertugliflozin 5 mg; 2.0 percent for ertugliflozin 15 mg; 3.3 percent for placebo). The rates of discontinuations due to AEs were low across all groups (3.2 percent for ertugliflozin 5 mg; 0.7 percent for ertugliflozin 15 mg; 0.7 percent for placebo).
In the study, a higher incidence of genital mycotic infections was observed in patients taking ertugliflozin 5 mg and ertugliflozin 15 mg (males: 4.9 percent and 3.7 percent, respectively, vs. no events for placebo; females: 8.0 percent and 12.7 percent, respectively, vs. 1.9 percent for placebo). Urinary tract infection rates were low across the ertugliflozin 5 mg, ertugliflozin 15 mg and placebo groups (2.6 percent, 4.6 percent and 2.0 percent, respectively).
Across groups, there were similar rates for symptomatic hypoglycemia (3.8 percent for ertugliflozin 5 mg; 0.7 percent for ertugliflozin 15 mg; 2.6 percent for placebo) and for hypovolemia adverse events (0.6 percent for ertugliflozin 5 mg; no events for ertugliflozin 15 mg; 0.7 percent for placebo).
Press release Pfizer and Merck, September 15, 2016