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Table 1 Exclusion criteria for the VISION study

From: Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of 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
  1. ULN: upper limit of normal.