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Table 2 Summary of efficacy and safety outcomes in patients treated with lixisenatide

From: Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data

 

Baseline FPG <  7 mmol/L (<  126 mg/dL) (controlled)

Baseline FPG ≥ 7 mmol/L (≥ 126 mg/dL) (uncontrolled)

PPG respondersa Lixisenatide (n = 156) Placebo (n = 47)

PPG non-respondersb Lixisenatide (n = 127) Placebo (n = 210)

Difference between groups (SE)

PPG respondersa Lixisenatide (n = 147) Placebo (n = 23)

PPG non-respondersb Lixisenatide (n = 157) Placebo (n = 204)

Difference between groups (SE)

Change in PPG from baseline to Week 24, mean (SE), mmol/L

 Lixisenatide

−7.75 (0.3)

−1.09 (0.4)

−6.69 (0.5)c

−9.20 (0.4)

−2.50 (0.4)

− 6.37 (0.5)c

 Placebo

−3.55 (0.6)

0.84 (0.3)

−5.32 (0.7)c

−6.13 (0.9)

−0.26 (0.3)

−6.22 (1.0)c

Change in FPG from baseline to Week 24, mean (SE), mmol/L

 Lixisenatide

0.54 (0.2)

1.63 (0.2)

−1.05 (0.2)c

−1.83 (0.2)

−0.51 (0.2)

−1.43 (0.3)c

 Placebo

0.11 (0.3)

1.39 (0.1)

−1.16 (0.3)c

−3.12 (10.6)

−0.88 (0.2)

−2.05 (0.6)c

Patients with HbA1c goal < 53 mmol/mol (<  7.0%) at Week 24, %

 Lixisenatide

61.6

30.9

−26.7 (5.6)c

52.3

16.1

−32.7 (5.0)c

 Placebo

55.3

12.9

−27.2 (8.2)c

39.0

7.2

−17.3 (10.7)

Change in HbA1c from baseline to Week 24, mean (SE), mmol/mol

 Lixisenatide

−10.1 (0.71)

−4.1 (0.80)

−6.1 (1.07)c

−11.7 (0.90)

−4.4 (0.87)

−7.1 (1.26)c

 Placebo

−5.4 (1.21)

−1.2 (0.61)

−3.7 (1.40)d

−7.7 (2.12)

−2.4 (0.76)

−4.4 (2.30)d

Symptomatic hypoglycemia during 24-week study period, rate (SE)

 Lixisenatide

0.40 (0.04)

0.36 (0.04)

0.03 (0.06)

0.26 (0.04)

0.19 (0.03)

0.06 (0.05)

 Placebo

0.13 (0.05)

0.23 (0.03)

−0.05 (0.06)

0.12 (0.07)

0.16 (0.03)

−0.04 (0.08)

Body weight change from baseline to Week 24, mean (SE), kg

 Lixisenatide

−1.22 (0.23)

−0.10 (0.25)

−1.23 (0.34)c

−0.73 (0.19)

−0.27 (0.19)

−0.62 (0.28)e

 Placebo

0.99 (0.41)

0.55 (0.19)

0.09 (0.47)

0.05 (0.54)

0.01 (0.16)

−0.05 (0.57)

Change in insulin dose from baseline to Week 24, mean (SE), mmol/L

 Lixisenatide

−0.61 (0.50)

−2.44 (0.61)

1.36 (1.18)

−0.37 (0.60)

0.24 (0.54)

−0.39 (1.23)

 Placebo

1.80 (0.79)

−0.16 (0.28)

1.87 (1.12)

1.26 (0.96)

1.25 (0.44)

−0.24 (1.72)

  1. Data were derived from a fixed-effects meta-analysis with inverse variance weights. Changes in HbA1c, PPG, FPG, body weight and insulin were analyzed using last observation carried forward at Week 24
  2. Abbreviations: HbA1c glycated hemoglobin, FPG fasting plasma glucose, PPG postprandial glucose, SE standard error
  3. aPPG < 10 mmol/L (< 180 mg/dL). bPPG ≥ 10 mmol/L (≥ 180 mg/dL). cP ≤ 0.001. dP = 0.008. eP = 0.024
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Clinical Diabetes and Endocrinology

ISSN: 2055-8260

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