Table 1

Baseline characteristics of subjects with T2DM in the 12-week study (study 2)

Placebo qAM (n = 41)Met DR 600 mg qAM (n = 39)Met DR 800 mg qAM (n = 40)Met DR 1,000 mg qAM (n = 40)Met XR 1,000 mg qPM (n = 40)Met XR 2,000 mg qPM (n = 40)All (N = 240)
Age, years51 ± 1054 ± 853 ± 1052 ± 951 ± 1052 ± 1052 ± 9
Male sex, %46463265454747
White, black, other,a %68/27/577/23/058/33/1075/23/360/35/568/30/368/28/4
BMI, kg/m233.6 ± 5.333.1 ± 5.733.5 ± 5.933.3 ± 5.632.8 ± 5.333.7 ± 5.233.3 ± 5.4
Duration of T2DM, years7.05.96.05.96.67.06.4
HbA1c, %7.4 ± 1.07.5 ± 0.97.3 ± 0.97.4 ± 1.07.4 ± 1.07.4 ± 1.07.4 ± 0.9
FPG at screening, mg/dL147 ± 37148 ± 43142 ± 35141 ± 30139 ± 34149 ± 41144 ± 37
FPG at baseline, mg/dL177 ± 55180 ± 50163 ± 40172 ± 44166 ± 50180 ± 58173 ± 50
FPG, change from screening to baseline, mg/dL31 ± 4533 ± 4421 ± 2631 ± 3427 ± 4431 ± 3429 ± 38
Patients receiving therapy with Metb prior to study entry (% IR/% XR)93 (87/13)80 (84/16)95 (84/16)90(92/8)85 (82/18)88 (80/20)88 (85/15)
Mean dose of prior Met,b mg (median)1,308 (1,000)1,532 (1,500)1,446 (1,500)1,492 (1,600)1,325 (1,000)1,541 (2,000)1,438 (1,500)
Patients with mild renal impairment,c %34264033433535
  • Data are reported as mean ± SD or percentage of subjects for the ITT population (N = 240), unless otherwise indicated. Other, Asian, Pacific Islander/Native Hawaiian, American Indian/Alaska Native, or other; qAM, once daily in the morning; qPM, once daily in the evening.

  • aPercentages may not add up to 100 because of rounding.

  • bIncludes Met IR and Met XR.

  • cMild renal impairment defined as eGFR ≥60 to <90 mL/min/1.73 m2.