This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, 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 alogliptin group (25 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 and alogliptin groups continued the same treatment until the end of the whole 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
458
SAL067 6mg(2 tablet) and placebo 25mg (1 tablet)
Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet)
placebo 6mg (2 tablet) and placebo 25mg (1 tablet)
1. Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
Guangzhou, Guangdong, 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、week16、week24、week 40 and week 52
Time frame: Baseline、week 4、week 8、week 12、week16、week24、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
Pancreatic 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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