XIGDUO XR is contraindicated in patients with: Hypersensitivity to the active substances or to any of the excipients; Diabetic ketoacidosis, diabetic pre-coma; Severe renal impairment (eGFR < 30 mL/min/1.73 m2); Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents (see Precautions); Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, pulmonary embolism, recent myocardial infarction, shock, acute significant blood loss, sepsis, gangrene, pancreatitis; During or immediately following surgery where insulin is essential, elective major surgery; Hepatic impairment; Acute alcohol intoxication, alcoholism; Lactation.