Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Frequency of Patients With Adverse Events (AEs)

This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.

Time frame: 78 weeks

Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events

Time frame: 78 weeks

Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)

As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').

Time frame: 78 weeks

Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events

Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)

Time frame: 78 weeks

Number of Patients With Abnormalities in Vital Signs

Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)

Time frame: 78 weeks

Number of Patients With Abnormalities in Haematology: Eosinophils

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.

Time frame: 78 weeks

Number of Patients With Abnormalities in Haematology: Haemoglobin

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.

Time frame: 78 weeks

Number of Patients With Abnormalities in Haematology: Haematocrit

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.

Time frame: 78 weeks

Number of Patients With Abnormalities in Haematology: Red Blood Cell Count

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^12/L.

Time frame: 78 weeks

Number of Patients With Abnormalities in Haematology: White Blood Cell Count

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^9/L (decrease) or a value greater than 20.1 \* 10\^9/L (increase).

Time frame: 78 weeks

Number of Patients With Abnormalities in Haematology: Platelets

For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 \* 10\^9/L (decrease) or a value greater than or equal to 700 \* 10\^9/L (increase).

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Potassium

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Amylase

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Creatinine

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Phosphate

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Calcium

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Sodium

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Glucose

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Albumin

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time frame: 78 weeks

Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

Time frame: 78 weeks