Table 1 Exclusion criteria for the VISION study

1.

Pregnant or lactating women

2.

Medical history of following diseases:

• Type 1 diabetes mellitus or diabetes caused by pancreatic injury or secondary diabetes: Cushing syndrome or acromegaly

• Acute complications of diabetes: ketoacidosis or non-ketotic hyperosmolar coma within the past 3 months

• Acute infections within 4 weeks prior to the screening (visit 1) that may affect the efficacy and safety of the study

• Any obvious diabetic complications such as symptomatic autonomic neuropathy, gastroparesis, worsening hyperglycemia in the absence of any comorbid illnesses, and conditions that may affect blood glucose

• History of kidney disease or clinical diagnosis of renal insufficiency indicated by serum creatinine ≥132 μmol/L (≥1.5 mg/dL) in males, and ≥123 μmol/L (≥1.4 mg/dL) in females

• History of a liver disease such as cirrhosis, hepatitis B, or hepatitis C (except carriers) or Alanine transaminase (ALT), aspartate aminotransferase (AST) greater than 2 times the ULN or total bilirubin greater than 2 times the ULN

• History of acute and chronic pancreatitis

• Malignant tumor in the past 5 years, including leukemia and lymphoma (except for carcinoma in situ of the skin)

• Torsades de pointes ventricular tachycardia or persistent, clinically relevant ventricular tachycardia or ventricular fibrillation or second-degree atrioventricular block (Mobitz type I and II) or third-degree atrioventricular block, or QTc prolongation (>500 ms)

• Myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, unstable angina, or stroke within the past 6 months

• Congestive heart failure requiring medical treatment

3.

Fasting plasma glucose >15 mmol/L (>270 mg/dL) at visit 1

4.

Clinically significant thyroid-stimulating hormone levels outside the normal range at visit 1

5.

Use of concomitant medications:

• Other antihyperglycemic agents besides metformin within 12 weeks of visit 1

• Long-term glucocorticoids (>7 consecutive days of treatment) within 4 weeks of visit 1

• Treatment with growth hormone or similar drugs

• Treatment with class Ia, Ib, or Ic, or class III antiarrhythmics

• Treatment with any drug with known and frequent toxicity to a major organ system within the past 3 months

6.

Use of other investigational drugs at visit 1, or within 30 days or 5 half-lives of visit 1, whichever is longer

7.

History of active substance abuse (including alcohol) within the past 2 years

8.

Potentially unreliable patients or patients who, in the opinion of the investigator, are unsuitable for the study