Linagliptin Add-on to Insulin Background Therapy

Inclusion criteria

• Diagnosis of type 2 diabetes mellitus prior to informed consent.
• Chinese male or female patients who are pre-treated with insulin alone or in combination with metformin:
• With maximum insulin dose of = 7.5 % to = 18 years at Visit 1.
• BMI 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
• Any other antidiabetic drug within 3 months prior to informed consent except those defined as background treatment via inclusion criterion 2.
• Acute coronary syndrome (non-STEMI (ST Segment Elevation Myocardial Infarction), STEMI and unstable angina pectoris), stroke or TIA (Transient ischemic attack) within 3 months prior to informed consent.
• Indication of liver disease, defined by serum levels of either ALT (Alanine aminotransferase) (SGPT (serum glutamic pyruvate transaminase )), AST (Aspartate aminotransferase) (SGOT (serum glutamic-oxaloacetic transaminase)), or alkaline phosphatase above 3 × upper limit of normal (ULN (upper limit of normal)) as determined during screening and/or run-in phase.
• Any contraindications to metformin according to the local label for those patients that enter the study with metformin therapy as provided in ISF (Investigator Site File).
• Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
• Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
• Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia).
• Known hypersensitivity or allergy to the investigational product or its recipients.
• Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
• Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM (Type 2 diabetes mellitus).
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
• Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
• Participation in another trial with an investigational drug within 2 months prior to informed consent or previous enrolment in this trial.
• Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial in the opinion of the investigator.