This is the phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in T2DM patients uncontrolled by metformin, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.
All eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the SAL067 group (12 mg once daily) or placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 groups continued the same treatment until the end of the whole 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
408
Peking University Hospital
Beijing, Beijing Municipality, China
HbA1c change from baseline at week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at week 24
Time frame: Baseline and week 24
HbA1c change from baseline at week 4,week 12,week 40 and week 52
Change From Baseline in Hemoglobin A1c (HbA1c) at week 4,week 12,week 40 and week 52
Time frame: Baseline, week 4, week 12, week 40 and week 52
FPG change from baseline at week 4, week 8, week 12, week 16, week 24, week 40 and week 52
Time frame: Baseline, week 4, week 8, week 12, week 24, week 40 and week 52
Percentage of patients with HbA1c <7.0% and HbA1c <6.5% at week 24 and week 52
Time frame: Baseline, week 24 and week 52
Percentage of patients required use of rescue therapy at week 24 and week 52
Time frame: Baseline, week 24 and week 52
Fasting c-peptide change from baseline at week 24 and week 52
Time frame: Baseline, week 24 and week 52
Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52
Time frame: Baseline, week 24 and week 52
eatic β-cell function change (calculated by HOMA-β ) from baseline at week 24 and week 52
Time frame: Baseline, week 24 and week 52
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