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Table 1 Key inclusion and exclusion criteria

From: Rationale, design and baseline characteristics of a 4-year (208-week) phase III trial of empagliflozin, an SGLT2 inhibitor, versus glimepiride as add-on to metformin in patients with type 2 diabetes mellitus with insufficient glycemic control

Inclusion criteria Exclusion criteria
Adult (aged ≥18 years) male or female patients with T2DM with insufficient glycemic control with diet, exercise and metformin IR* (≥1500 mg/day or maximum tolerated dose, or maximum dose according to local label, with dose unchanged for 12 weeks prior to randomization) Blood glucose level >240 mg/dL (13.3 mmol/L) after an overnight fast during placebo run-in, confirmed by a 2nd measurement
HbA1c ≥7% and ≤10% at screening Use of any anti-diabetes drugs other than metformin IR ≤12 weeks prior to randomization
BMI ≤45 kg/m2 at screening Bariatric surgery within 2 years; treatment with anti-obesity drugs within 3 months of screening; any treatment leading to unstable body weight
Female patients: post-menopausal, or pre-menopausal and using appropriate contraception; not pregnant/breastfeeding eGFR <60 mL/min/1.73 m2 (MDRD) during screening or placebo run-in
  Indication of liver disease (ALT, AST or alkaline phosphatase >3 x ULN) during screening or placebo run-in
  History of cancer within 5 years (except basal cell carcinoma)
  Acute coronary syndrome, stroke or transient ischemic attack within 3 months of informed consent
  Disorders causing unstable red blood cells; treatment with systemic steroids; change in dose of thyroid hormones within 6 weeks of screening; any uncontrolled endocrine condition (except T2DM)
  Alcohol or drug abuse within 3 months of informed consent
  Taking an investigational drug ≤ 30 days prior to receiving study drug
  1. Legend: T2DM type 2 diabetes mellitus, IR immediate release, HbA 1c glycosylated hemoglobin, BMI body mass index, eGFR estimated glomerular filtration rate, MDRD Modified Diet Renal Disease formula, ALT alanine transaminase, AST aspartate transaminase, ULN upper limit of normal.
  2. *One patient took metformin extended release.