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 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
• HbA1c Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
• HbA1c Change From Baseline at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
  HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
• HbA1c Change From Baseline at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
  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.
• HbA1c Change From Baseline at Week 42 [ Time Frame: Baseline and Week 42 ] [ Designated as safety issue: No ]
  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.
• HbA1c Change From Baseline at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  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.
• HbA1c Change From Baseline at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
• Percentage of Patients With HbA1c < 6.5% at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  The percentage of patients with an HbA1c value below 6.5% at week 12 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
• Percentage of Patients With HbA1c <7.0% at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  The percentage of patients with an HbA1c value below 7.0% at week 12 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
• Percentage of Patients With HbA1c Lowering by 0.5% at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 12 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
• FPG Change From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  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
• FPG Change From Baseline at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
• FPG Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  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
• FPG Change From Baseline at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
  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
• FPG Change From Baseline at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
  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
• FPG Change From Baseline at Week 42 [ Time Frame: Baseline and Week 42 ] [ Designated as safety issue: No ]
  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
• FPG Change From Baseline at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  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
• FPG Change From Baseline at week52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  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
• Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.

to determine safety, efficacy and tolerability of BI 1356 versus placebo

• Drug: BI 1356
  BI 1356 dosed once daily
• Drug: placebo
  placebo matching BI 1356 taken once daily

• Experimental: BI 1356
  patient to receive a tablet containing BI 1356 once daily
  Intervention: Drug: BI 1356
• Placebo Comparator: placebo
  patient to receive a tablet identical to BI 1356 once daily
  Intervention: Drug: placebo

Inclusion criteria:

• Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
• Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
• Age 18 or over and not older than 80 years

Exclusion criteria:

• Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
• Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
• Unstable or acute congestive heart failure