Table 1 Key inclusion and 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 2^nd measurement

HbA_1c ≥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