This is a phase I placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of Globalagliatin Hydrochloride (SY-004) after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus (T2DM).
Name: Globalagliatin Hydrochloride
Description: once daily, oralType: DrugGlobalagliatin Hydrochloride (SY-004)
Name: Placebo
Description: once daily, oralType: DrugPlacebo
Description: Compared with placebo, the mean change in glucose AUC from baseline at D28.
Measure: the mean change in glucose area under curve (AUC) from baseline. Time: 28 daysDescription: Compared with placebo, the fasting plasma glucose from baseline at D7，D14，D21 and D28.
Measure: the fasting plasma glucose from baseline Time: 7, 14, 21, 28 daysDescription: Compared with placebo, the changes of MMTT (mixed-meal tolerance test) results from baseline at D28
Measure: the changes of MMTT (mixed-meal tolerance test) results from baseline Time: 28 daysDescription: Compared with placebo, the mean changes of average 7-points blood glucose profiles from baseline at D7，D14，D21 and D28.
Measure: the mean changes of average 7-points blood glucose profiles from baseline Time: 7, 14, 21, 28 daysDescription: Compared with placebo, the mean changes of average 14-points blood glucose profiles from baseline at D7，D14，D21 and D28.
Measure: the mean changes of average 14-points blood glucose profiles from baseline Time: 7, 14, 21, 28 daysDescription: Compared with placebo, the mean changes of post-prandial blood glucose from baseline at D7，D14，D21 and D28.
Measure: the mean changes of post-prandial blood glucose from baseline Time: 7, 14, 21, 28 daysDescription: The genetic（TCF7L2 rs7903146 and GCKR rs780094）effects on response of SY-004 in T2DM patients.
Measure: genetic: TCF7L2 ( Transcription factor 7-like 2) rs7903146 and GCKR (glucokinase regulatory protein) rs780094 ) Time: 28 daysDescription: Compared with placebo, the changes of GA (Glycated albumin) from baseline at D28.
Measure: the changes of GA (Glycated albumin) from baseline Time: 28 daysAllocation: Randomized
Parallel Assignment
There are 3 SNPs
Compared with placebo, the mean changes of post-prandial blood glucose from baseline at D7，D14，D21 and D28.. genetic: TCF7L2 ( Transcription factor 7-like 2) rs7903146 and GCKR (glucokinase regulatory protein) rs780094 ).
The genetic（TCF7L2 rs7903146 and GCKR rs780094）effects on response of SY-004 in T2DM patients.. the changes of GA (Glycated albumin) from baseline.
Compared with placebo, the mean changes of post-prandial blood glucose from baseline at D7，D14，D21 and D28.. genetic: TCF7L2 ( Transcription factor 7-like 2) rs7903146 and GCKR (glucokinase regulatory protein) rs780094 ).
The genetic（TCF7L2 rs7903146 and GCKR rs780094）effects on response of SY-004 in T2DM patients.. the changes of GA (Glycated albumin) from baseline.