Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

HbA1c Change From Baseline at Week 36

HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.

Time frame: Baseline and Week 36

HbA1c Change From Baseline at Week 42

HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.

Time frame: Baseline and Week 42

HbA1c Change From Baseline at Week 48

HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.

Time frame: Baseline and Week 48

The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment

The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=6.5%

Time frame: Baseline and Week 52

The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment

The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=7%.

Time frame: Baseline and Week 52

Percentage of Patients With HbA1c Lowering by 0.5% at Week 52

The percentage of patients with an HbA1c reduction from baseline \>=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).

Time frame: Baseline and Week 52

FPG Change From Baseline at Week 12

This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs

Time frame: Baseline and Week 12

FPG Change From Baseline at Week 18

Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs

Time frame: Baseline and Week 18

FPG Change From Baseline at Week 24

This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs

Time frame: Baseline and Week 24

FPG Change From Baseline at Week 30

This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs

Time frame: Baseline and Week 30

FPG Change From Baseline at Week 36

This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs

Time frame: Baseline and Week 36

FPG Change From Baseline at Week 42

This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs

Time frame: Baseline and Week 42

FPG Change From Baseline at Week 48

This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs

Time frame: Baseline and Week 48

FPG Change From Baseline at week52

This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs

Time frame: Baseline and Week 52

Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time

Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.

Time frame: Baseline and Week 52

Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG

Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.

Time frame: first administration of randomised treatment to ....