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. Author manuscript; available in PMC: 2018 Nov 1.
Published in final edited form as: Gastroenterology. 2017 Jul 29;153(5):1240–1250.e2. doi: 10.1053/j.gastro.2017.07.035

Table 2.

Change from baseline to week 12 in DGSSD (4-symptom composite scorea) and GEBT

Parameter Placebo BID (n=88) RM 10 μg BID (n=86) RM 30 μg BID (n=91) RM 100 μg BID (n=63)
Weekly Vomiting Episodes
Placebo 10 μg 30 μg 100 μg
N=85 N=81 N=86 N=66
Baseline, mean ± SD 5.7 ±6.0 7.7 ±17.2 6.9 ±10.3 4.8 ±5.2
Week 12, mean ± SD 2.8 ±5.9 3.9 ±17.1 3.1 ±9.1 3.8 ±13.7
Change from baseline, mean ± SD −2.9 ±5.8 −3.7 ±12.5 −3.8 ±7.6 −1.1 ±13.5
Percent change from baselinea −70.5% −74.9% −75.8% −73.4
p-valueb (difference from placebo) 0.36 0.25 0.59
DGSSD 4 symptom composite scorec
Baseline, mean ± SD 22.7 ± 7.3 22.7 ± 7.9 22.4 ± 6.7 24.0 ± 7.5
Week 12, mean ± SD 17.1 ± 8.8 14.0 ± 10.3 13.8 ± 9.6 14.2 ± 9.5
Change from baseline, mean ± SD −5.6 ± 8.8 −8.7 ± 9.0 −8.7 ± 9.0 −9.7 ± 8.8
Change from baselined −6.07 −7.91 −8.41 −8.64
LS mean difference vs. placebo −1.85 −2.34 −2.57
p-value (difference from placebo)e 0.134 0.053 0.052
GEBT (T½ in min)
Baseline, mean ± SD 127.1 ± 36.5 126.8 ± 37.6 128.6 ± 35.9 133.6 ± 35.4
Week 12, mean ± SD 126.3 ± 39.8 112.8 ± 43.5 115.8 ± 45.7 118.0 ± 49.5
Change from baseline, mean ± SD −0.0 ± 38.5 −12.7 ± 38.1 −12.8 ± 36.5 −13.6 ± 40.5
Change from baseline −0.43 −13.36 −12.55 −12.47
LS mean difference vs. placebo −12.93 −12.12 −12.04
95% CI of difference −24.04; −1.82 −22.92; −1.33 −24.11; 0.04
p-value (difference from placebo)b 0.023 0.028 0.051

BID, twice daily; CI = confidence interval; DGSSD, Diabetic Gastroparesis Symptom Severity Diary; GEBT, gastric emptying breath test; LS, least squares; RM, relamorelin; SD, standard deviation

a

Analysis was done on log-transformed change-from-baseline of weekly least square means for vomiting data, and reported as percent change from baseline.

b

Two-sided p-value from longitudinal, mixed-effects model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, as well as baseline and baseline-by-week interaction values as the covariates with unstructured variance-covariance correlation matrix being common to all subjects for the repeated measures over treatment weeks

c

Nausea, post-prandial fullness, abdominal pain, bloating; composite score in total numeric points;

d

Analysis done on change-from-baseline data for sum of weekly averages of 4 individual symptom scores (nausea, abdominal pain, post-prandial fullness, and bloating);