Table 2.

Changes in the efficacy endpoints from baseline to weeks 24 and 52

Endpoints	Dorzagliatin and metformin (n = 376)	Placebo and metformin (n = 375)	ETD, dorzagliatin vs. placebo (95% CI)
HbA1c, %
Week 4	−0.71 ± 0.02	−0.17 ± 0.02	−0.54 (−0.61, 0.48)
Week 12	−1.13 ± 0.04	−0.28 ± 0.04	−0.85 (−0.96, 0.74)
Week 24	−1.02 ± 0.05	−0.36 ± 0.05	−0.66 (−0.79, −0.53)
P value	–	–	<0.0001
Week 52a	−0.81 ± 1.059	−0.96 ± 0.971	–
2h-PPG, mg dl−1
Week 12	−99.5 ± 3.1	−45.0 ± 3.1	−54.5 (−62.82, −46.44)
Week 24	−98.1 ± 3.3	−53.5 ± 3.3	−44.6 (−53.28, −35.82)
Week 52a	−92.2 ± 69.8	−104.9 ± 72.5	–
FPG, mg dl−1
Week 4	−16.9 ± 1.5	−0.9 ± 1.5	−16.0 (−19.98, −11.88)
Week 12	−15.7 ± 1.6	−4.5 ± 1.6	−11.0 (−15.30, −6.84)
Week 24	−12.1 ± 1.9	−5.2 ± 1.9	−6.8 (−12.06, −1.62)
Week 52a	−8.6 ± 37.4	−15.3 ± 35.8	–
HbA1c <7.0%b, %
Week 8	40.6	5.6	-
Week 24	44.4	10.7	7.60 (5.05, 11.42)
Composite endpointb (HbA1c <7.0% without hypoglycemia and no weight gain), %
Week 24	26.6	7.7	4.31 (2.75, 6.75)
Fasting insulin, µIU ml−1
Week 24	−0.59 ± 2.76	3.51 ± 2.756	−4.10 (−11.76, 3.56)
HOMA2-βc
Week 24	3.82 ± 0.71	1.40 ± 0.70	2.43 (0.59, 4.26)
HOMA2-IRc
Week 24	−0.17 ± 0.03	−0.09 ± 0.03	−0.08 (−0.15, −0.01)

The values are presented as the estimated LS mean changes ± s.e. from baseline. The LS mean differences and corresponding 95% CIs were estimated in the FAS using an MMRM.

^aValues are presented as arithmetic means ± s.d. and were calculated using paired t-tests for baseline comparisons.

^bThe response rate was estimated in the FAS with the data imputed by LOCF. ETD is presented as the OR and 95% CI and was calculated using logistic regression analysis.

^cThe values are presented as the estimated LS means ± s.e. The LS mean differences in the FAS were calculated using ANCOVA with the data imputed by the LOCF. Data were computed using the HOMA2 Calculator version 2.2.3: https://www.dtu.ox.ac.uk/homacalculator/download.php.

All statistical tests were two-sided at a significance level of 0.05.