Table 1

Baseline and 6-week change in HbA1c level, FBG level, body weight, and daily insulin dose during the study

LixisenatidePlaceboP valuea
Baseline HbA1c (mmol/mol; IFCC)61.4 ± 3.059.9 ± 2.80.548
Baseline HbA1c (%; DCCT)7.7 ± 0.37.6 ± 0.30.548
6-week HbA1c (mmol/mol; IFCC)55.6 ± 2.458.8 ± 2.90.020
6-week HbA1c (%; DCCT)7.3 ± 0.27.5 ± 0.30.020
Change in HbA1c (mmol/mol; IFCC)−5.8 ± 1.2 (P < 0.001)b−1.0 ± 1.3 (P = 0.432)b0.042
Change in HbA1c (%; DCCT)−0.5 ± 0.1 (P < 0.001)b−0.1 ± 0.1 (P = 0.432)b0.042
Baseline FBG (mmol/L)9.7 ± 0.69.3 ± 0.70.547
6-week FBG (mmol/L)8.3 ± 0.69.3 ± 0.70.023
Change in FBG (mmol/L)−1.6 ± 0.4 (P = 0.002)b0.0 ± 0.6 (P = 0.986)b0.046
Baseline body weight (kg)99.5 ± 4.699.8 ± 4.50.962
6-week body weight (kg)97.7 ± 4.499.1 ± 4.40.823
Change in body weight (kg)−1.7 ± 0.4 (P < 0.001)b−0.6 ± 0.4 (P = 0.095)b0.043
Baseline daily insulin dose (units)39 ± 2439 ± 250.934
6-week daily insulin dose (units)37 ± 2440 ± 240.684
Change in daily insulin dose (units)−1.8 ± 4.1 (P = 0.076)b0.8 ± 2.1 (P = 0.135)b0.023
  • Data are reported as the mean ± SD, unless otherwise indicated.

  • aP value for the probability level of random difference between the two treatments.

  • bP value for the probability level of random difference before and after treatment within each treatment arm. DCCT, Diabetes Control and Complications Trial unit; IFCC, International Federation of Clinical Chemistry and Laboratory Medicine unit.