Effects of LGI Steam Bread on Glycemia Control in T2DM in China

Inclusion criteria

• Age ≥18yrs；
• Diagnosed as Type 2 Diabetes;
• Had been on a stable hypoglycemic regimen for at least 30 days prior to screening；
• HbA1c between 7.5% and 11.0% (both upper and lower limits included) in the 90 days prior to screening;
• Fasting C-peptide ≥1.0ng/ml in the 90 days prior to screening;
• Be willing to accept and adhere to LGI steamed bread as a staple food for at least 14 days

Exclusion criteria

• Diagnosed with type 1 diabetes, or secondary diabetes;
• Have clinically significant liver disease, moderate/severe kidney injury, or end-stage renal disease;
• Has unstable CV disorders, including heart failure (NYHA) class III or IV), intractable angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥105mmHg);
• An Acute Coronary Syndrome event (ACS) occurred within the 6 months prior to randomization